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Seagen Inc.(NasdaqGS:SGEN) dropped from Russell 1000 Value Index

2022-06-24 00:00:00

Seagen Inc.(NasdaqGS:SGEN) dropped from Russell 1000 Value Index

Seagen Inc.(NasdaqGS:SGEN) dropped from Russell Small Cap Comp Value Index

2022-06-24 00:00:00

Seagen Inc.(NasdaqGS:SGEN) dropped from Russell Small Cap Comp Value Index

Seagen Inc.(NasdaqGS:SGEN) dropped from Russell 3000E Value Index

2022-06-24 00:00:00

Seagen Inc.(NasdaqGS:SGEN) dropped from Russell 3000E Value Index

Seagen Inc.(NasdaqGS:SGEN) dropped from Russell Midcap Value Index

2022-06-24 00:00:00

Seagen Inc.(NasdaqGS:SGEN) dropped from Russell Midcap Value Index

Seagen Inc.(NasdaqGS:SGEN) dropped from Russell 3000 Value Index

2022-06-24 00:00:00

Seagen Inc.(NasdaqGS:SGEN) dropped from Russell 3000 Value Index

Merck Reportedly Pushes Forward with Potential Deal for Seagen

2022-06-23 23:51:00

Merck & Co., Inc. (NYSE:MRK) is pushing forward with a potential deal for Seagen Inc. (NasdaqGS:SGEN), according to people familiar with the matter, in what would be one of the largest takeovers of the year. The Wall Street Journal reported last week that Merck was in talks to buy Seagen, which would beef up the pharmaceutical giant’s cancer-drug portfolio, but that no agreement was imminent. The talks have picked up pace and the two companies are scheduled to meet this week, some of the people said on June 23, 2022. It couldn’t be learned whether Merck has already submitted a formal offer for the Washington state company. Other suitors were eyeing Seagen, people familiar with the matter have said, but none has surfaced yet.

Merck, Other Suitors Reportedly Interested in Acquiring Seagen

2022-06-17 15:31:00

Merck & Co., Inc. is eyeing a purchase of Seagen Inc., according to people familiar with the matter. Talks have been under way for a while and a deal isn’t imminent, the people said, cautioning that pulling one off could be tricky given the heightened risk of a regulatory challenge. It is possible the companies could end up striking a marketing agreement instead, some of the people said. Other unnamed suitors are also eyeing Seagen, a perennially speculated takeover target, some of the people said.

Genmab A/S and Seagen Inc. Present Data from Tisotumab Vedotin (TIVDAK) Clinical Development Program and Additional Cervical Cancer Research at ASCO 2022 Annual Meeting

2022-06-06 15:00:00

Genmab A/S and Seagen Inc. announced interim data from the innovaTV 205 trial, which included data evaluating tisotumab vedotin (TIVDAK®) in combination with pembrolizumab (Cohort E) in patients with recurrent or metastatic cervical cancer (r/mCC) who have not received prior systemic therapy, with a confirmed objective response rate (ORR) of 41% (95% Confidence Interval [CI]: 24% to 59%) and median durability of response that was not reached within almost 19 months of median follow up. Data were presented during an oral session at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting on June 6. Dose expansion Cohort E enrolled 33 patients with recurrent or metastatic cervical cancer who had not received any prior systemic therapy. At the time of data cutoff, the confirmed ORR among 32 evaluable patients was 41% (95% Confidence Interval [CI], range 24% to 59%), with 16% of patients (n=5) achieving complete responses and 25% of patients (n=8) achieving partial responses. Median duration of response (DOR) was not reached. Median progression-free survival (PFS) was 5.3 months (95% CI: 4.0 to 12.2). Building on data presented at the European Society for Medical Oncology (ESMO) Congress 2021, additional longer-term follow-up data from Cohorts D (tisotumab vedotin in combination with carboplatin in previously untreated patients) and Cohort F (tisotumab vedotin in combination with pembrolizumab in previously treated patients) of the innovaTV 205 trial were also included in the ASCO 2022 oral presentation. In Cohort E, the most common treatment-emergent adverse events (TEAEs) were alopecia (61%), diarrhea (55%), epistaxis (49%), conjunctivitis (45%), and nausea (46%). Prespecified adverse events (AEs) of interest (grade 1-2/grade =3) with tisotumab vedotin included ocular (58%/9%), peripheral neuropathy (49%/3%), and bleeding (61%/6%). Tisotumab vedotin in combination with pembrolizumab across lines of treatment (Cohorts E/F), and with carboplatin (Cohort D) in first-line, demonstrated a tolerable and manageable safety profile. Across all three cohorts, no new safety signals were reported outside of known adverse events associated with the individual agents. Tisotumab vedotin is approved for treatment of patients with previously treated recurrent or metastatic cervical cancer in the US and is commercialized under the tradename TIVDAK. See TIVDAK U.S. Important Safety Information, including Boxed Warning, below. One highlight of real-world studies presented is a poster discussion on the Cervical Cancer Geographical Burden Analyzer. This is an open access, web-based, interactive tool to visualize geographical areas in the US where cervical cancer education or healthcare resource needs are high. Additional updates from the tisotumab vedotin clinical development program were presented at the ASCO 2022 Annual Meeting, including trial-in-progress overviews for innovaTV 205/ENGOT-cx8/GOG-3024 evaluating first-line tisotumab vedotin in combination with pembrolizumab, carboplatin and bevacizumab in first-line r/mCC; and for innovaTV 207 Part D evaluating tisotumab vedotin in combination with pembrolizumab and platinum in squamous cell carcinoma of the head and neck (HNSCC) and squamous cell non-small cell lung cancer (sqNSCLC).

Seagen Inc. Presents at DIA Global Annual Meeting 2022, Jun-19-2022

2022-05-28 18:13:00

Seagen Inc. Presents at DIA Global Annual Meeting 2022, Jun-19-2022 . Venue: Chicago, Illinois, United States. Speakers: Linda Bowen, Head of Global Regulatory Policy and Intelligence.

Seagen Inc. Presents at The 2022 ASCO Annual Meeting, Jun-03-2022 01:00 PM

2022-05-26 21:25:00

Seagen Inc. Presents at The 2022 ASCO Annual Meeting, Jun-03-2022 01:00 PM. Venue: McCormick Place, Chicago, Illinois, United States.

Seagen Inc. Presents at European Hematology Association 2022 Annual Congress, Jun-10-2022 11:30 AM

2022-05-26 21:25:00

Seagen Inc. Presents at European Hematology Association 2022 Annual Congress, Jun-10-2022 11:30 AM. Venue: Vienna, Austria.

Takeda Pharmaceutical Company Limited and Seagen Inc. to Highlight ADCETRIS® Combination Data Showing Statistically Significant Improvement in Overall Survival (OS) for Patients with Advanced Hodgkin Lymphoma

2022-05-26 21:25:00

Takeda Pharmaceutical Company Limited and Seagen Inc. announced that overall survival (OS) data from the Phase 3 ECHELON-1 clinical trial of an ADCETRIS® (brentuximab vedotin) plus chemotherapy combination will be presented in an oral session at the 59th American Society of Clinical Oncology (ASCO) Annual Meeting on June 3, 2022, 1:00-4:00 PM CT, and at the 27th European Hematology Association (EHA) Annual Meeting on June 10, 2022, 11:30 – 12:45 CEST. Data from the ECHELON-1 trial demonstrated a statistically significant improvement in OS in adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma treated with ADCETRIS plus doxorubicin, vinblastine and dacarbazine (A+AVD) vs. doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). With approximately six years median follow up (73 months), patients receiving A+AVD had a 41% reduction in the risk of death (hazard ratio [HR] 0.59; 95% confidence interval [CI]: 0.396 to 0.879), with an estimated OS rate (95% CI) of 93.9% (91.6, 95.5) at 6 years. The safety profile of ADCETRIS was consistent with previous studies, and no new safety signals were observed. Please see Important Safety Information, including a SPECIAL/BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below. ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma in combination with AVD in the United States and for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD in Europe. First-line brentuximab vedotin plus chemotherapy to improve overall survival in patients with stage III/IV classical Hodgkin lymphoma: An updated analysis of ECHELON-1. (Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia on Friday, June 3, 2022, 1:00 PM-4:00 PM CT at McCormick Place, Hall A8). Key findings, which will be presented by Dr. Ansell, include: The trial achieved its key secondary endpoint with the combination of A+AVD, resulting in a statistically significant improvement in OS versus the control arm of ABVD as assessed by an Independent Review Facility (IRF) (HR 0.59; p-value=0.009). This corresponds to a 41% reduction in the risk of death. At a median follow up of 73 months, 39 and 64 OS events occurred in the A+AVD and ABVD arms, respectively. Estimated six-year OS rates (95% CI) were 93.9% (91.6, 95.5) with A+AVD vs. 89.4% (86.6, 91.7) with ABVD. Subgroup analyses supported a consistent benefit for A+AVD vs. ABVD. The six-year PFS estimate (95% CI) was 82.3% (79.1, 85.0) with A+AVD vs. 74.5% (70.8, 77.7) with ABVD. A+AVD resulted in a manageable safety profile consistent with prior reports. Treatment-emergent peripheral neuropathy continued to resolve or improve in both arms, with 86% (379/443) and 87% (249/286) of patients in the A+AVD and ABVD arms, respectively, either completely resolving (72% vs. 79%) or improving (14% vs. 8%) by last follow up. Fewer patients reported second malignancies in the A+AVD vs. ABVD arm (23 vs. 32). No new safety signals were identified.

Seagen Inc. Announces Positive Topline Results of Pivotal Phase 2 Clinical Trial of TUKYSA(R) (tucatinib) in Combination with Trastuzumab in HER2-Positive Metastatic Colorectal Cancer

2022-05-23 12:00:00

Seagen Inc. announced positive topline results from the pivotal phase 2 MOUNTAINEER clinical trial investigating TUKYSA® (tucatinib) in combination with trastuzumab in patients with previously treated HER2-positive metastatic colorectal cancer (mCRC). Data from this trial will form the basis of a planned supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) under the FDA’s Accelerated Approval Program. Merck, known as MSD outside the U.S. and Canada, is commercializing TUKYSA in regions outside of the U.S., Canada and Europe and plans to discuss these results with health authorities as it continues to accelerate the filing of TUKYSA in its territory. Results showed a 38.1% confirmed objective response rate (cORR) [95% Confidence Interval (CI): 27.7, 49.3] per blinded independent central review (BICR). The median duration of response (DoR) per BICR was 12.4 months [95% CI: 8.5, 20.5]. The combination of tucatinib and trastuzumab was generally well-tolerated, and the most common (greater than or equal to 20%) treatment-emergent adverse events were diarrhea, fatigue, nausea and infusion-related reaction, which were primarily low-grade. Full data from the MOUNTAINEER trial will be presented by John H. Strickler, M.D., Duke University Medical Center, at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in Barcelona, Spain from June 29 through July 2, 2022.

Seagen Announces Resignation of Clay Siegall as CEO

2022-05-16 00:00:00

Seagen announced resignation of Clay Siegall as CEO. Siegall, who co-founded Seagen in 1997, had taken a leave of absence last week after news of his arrest appeared in pharmaceutical trade publications. His resignation was approved by Seagen's board of directors. The 3,000-employee company said it has appointed Chief Medical Officer Roger Dansey as interim CEO while it searches for a new chief executive. Dansey has been with the company since 2018, according to SEC filings. Seagen shares rose nearly 6% following the news of Siegall's resignation.

Seagen Inc., Annual General Meeting, May 13, 2022

2022-05-13 14:33:00

Seagen Inc., Annual General Meeting, May 13, 2022, at 13:00 Pacific Standard Time.

Seagen Inc. - Shareholder/Analyst Call

2022-05-13 14:33:00

AGM

The European Hematology Association, European Hematology Association 2022 Annual Congress, Jun 09, 2022 through Jun 17, 2022

2022-05-10 11:00:00

The European Hematology Association, European Hematology Association 2022 Annual Congress, Jun 09, 2022 through Jun 17, 2022. Venue: Vienna, Austria.

Seagen President, CEO and Chairman Clay Siegall Takes Leave of Absence

2022-05-09 10:00:00

The Board of Directors of Seagen Inc. announced that President, CEO and Chairman Clay Siegall, Ph.D. is on a leave of absence. The company is aware of an alleged incident of domestic violence that occurred recently at Dr. Siegall’s home. Dr. Siegall has denied these allegations and has informed the company that he is engaged in a divorce. The Board of Directors has formed a committee of independent directors and is conducting a thorough investigation with the assistance of an independent law firm. Roger Dansey, M.D., Seagen’s Chief Medical Officer since 2018, has been appointed Interim CEO. Dr. Dansey joined Seagen as Chief Medical Officer in 2018, bringing extensive experience in cancer drug development. His deep oncology background and proven leadership has helped Seagen evolve into a global, multi-product oncology company with a robust and diverse pipeline. Prior to joining Seagen, Dr. Dansey was Therapeutic Area Head for Late-Stage Oncology at Merck & Co. Inc., where he was responsible for registration efforts for Keytruda® (pembrolizumab) across multiple tumor types. Earlier in his career, Dr. Dansey held leadership positions at Gilead Sciences and Amgen. He holds an M.D. from the University of Witwatersrand in Johannesburg, South Africa. He serves as a member of the board of directors for INOVIO Pharmaceuticals Inc.

Seagen Inc. Announces CEO Changes

2022-05-09 10:00:00

The Board of Directors of Seagen Inc. announced that President, CEO and Chairman Clay Siegall, Ph.D. is on a leave of absence. The company is aware of an alleged incident of domestic violence that occurred recently at Dr. Siegall’s home. Dr. Siegall has denied these allegations and has informed the company that he is engaged in a divorce. The Board of Directors has formed a committee of independent directors and is conducting a thorough investigation with the assistance of an independent law firm. Roger Dansey, M.D., Seagen’s Chief Medical Officer since 2018, has been appointed Interim CEO. Dr. Dansey joined Seagen as Chief Medical Officer in 2018, bringing extensive experience in cancer drug development. His deep oncology background and proven leadership has helped Seagen evolve into a global, multi-product oncology company with a robust and diverse pipeline. Prior to joining Seagen, Dr. Dansey was Therapeutic Area Head for Late-Stage Oncology at Merck & Co. Inc., where he was responsible for registration efforts for Keytruda® (pembrolizumab) across multiple tumor types. Earlier in his career, Dr. Dansey held leadership positions at Gilead Sciences and Amgen. He holds an M.D. from the University of Witwatersrand in Johannesburg, South Africa. He serves as a member of the board of directors for INOVIO Pharmaceuticals Inc.

Seagen Inc. Presents at 2022 Fc Receptor and IgG Targeted Therapies Conference, Apr-26-2022

2022-04-21 15:29:00

Seagen Inc. Presents at 2022 Fc Receptor and IgG Targeted Therapies Conference, Apr-26-2022 . Venue: Boston, Massachusetts, United States. Speakers: Alyson Smith, Associate Director Cancer Target Discovery.

Hanson Wade Limited, 2022 Fc Receptor and IgG Targeted Therapies Conference, Apr 26, 2022 through Apr 28, 2022

2022-04-21 09:39:00

Hanson Wade Limited, 2022 Fc Receptor and IgG Targeted Therapies Conference, Apr 26, 2022 through Apr 28, 2022. Venue: Boston, Massachusetts, United States.

Seagen Announces Plans to Expand Pacific Northwest Biomanufacturing Capacity to Support Growing Portfolio of Transformative Cancer Medicines

2022-04-20 13:00:00

Seagen Inc. announced plans to build a new facility in Everett, Washington, to expand the company’s biomanufacturing capacity and enable the company greater control and flexibility over the production of its medicines to treat cancer. The 270,000-square-foot facility will be built north of the company’s U.S. headquarters in Bothell, Washington. Seagen expects to have the facility operational in 2024 and ultimately employ up to 200 highly skilled workers to produce medicines for clinical trials and the commercial market. The new biomanufacturing facility is a “greenfield” project, constructed from the ground up into a modern production facility to make advanced medicines. Seagen plans to make antibody-based medicines (also called biologics) in the new fully integrated plant for the commercial market and for use in clinical sites around the world. The new facility will add to Seagen’s existing manufacturing site in the Bothell area. This project will create up to 150 new jobs during the initial construction of the shell and core of the building. Seagen has four marketed therapies used in the treatment of Hodgkin lymphoma and urothelial (bladder), breast and cervical cancers. In research and development, Seagen is advancing more than 17 programs, including approved products and a deep and diverse early- and late-stage pipeline across a range of solid tumors and hematologic malignancies.

Seagen Inc. Adopts Amended and Restated Bylaws of the Company

2022-04-15 20:36:00

On April 12, 2022, the board of directors of Seagen Inc. (the 'Company'), adopted, effective immediately, amended and restated bylaws of the company (as amended, the “Amended and Restated Bylaws”). Among other changes, the Amended and Restated Bylaws: update provisions regarding the conduct of business at meetings of stockholders to provide additional flexibility in the conduct of such meetings; and unless the Company consents in writing to the selection of an alternative forum, designate, to the fullest extent permitted by law, (A)certain Delaware courts as the forum for (i)any derivative claim brought on behalf of the Company, (ii)any claim for breach of a fiduciary duty owed by any director, officer or other employee of the Company, (iii)any claim arising out of or relating to the General Corporation Law of Delaware (“DGCL”) (including any claims for which DGCL confers jurisdiction to such courts) and claims governed by the internal affairs doctrine and (iv)any claim arising out of or related to the Company’s organizational documents (including claims seeking to interpret, apply, enforce or determine the validity of such documents); and (B)the federal district courts as the forum for any complaint asserting a cause of action arising under the Securities Act of 1933, as amended. The Amended and Restated Bylaws also include updates for current provisions of the DGCL and include certain other clarifying, administrative, conforming, ministerial and related revisions related to, among other things, director nominations, notice provisions, naming of proxies, electronic board consents and delivery of communications to the Company.

Astellas Pharma Inc. and Seagen Inc. Announces European Commission Approves PADCEV™ (Enfortumab Vedotin) for Locally Advanced or Metastatic Urothelial Cancer

2022-04-13 15:45:00

Astellas Pharma Inc. and Seagen Inc. announced that the European Commission (EC) has approved PADCEV™ (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor. The EC approval is supported by data from the global phase 3 EV-301 trial that demonstrated an overall survival (OS) benefit compared with chemotherapy. The EV-301 trial compared enfortumab vedotin to chemotherapy in adult patients (n=608) with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. At the time of the pre-specified interim analysis, patients who received enfortumab vedotin (n=301) in the trial lived a median of 3.9 months longer than those who received chemotherapy (n=307). Median OS was 12.9 vs. 9 months, respectively [Hazard Ratio=0.70 (95% Confidence Interval [CI]: 0.56, 0.89), p=0.001]. Across clinical trials, the most common adverse reactions with enfortumab vedotin were alopecia, fatigue, decreased appetite, peripheral sensory neuropathy, diarrhea, nausea, pruritus, dysgeusia, anemia, weight decreased, rash maculo-papular, dry skin, vomiting, aspartate aminotransferase increased, hyperglycemia, dry eye, alanine aminotransferase increased and rash. Results from the EV-301 trial are intended to support global registrations for enfortumab vedotin. The EC marketing authorization for enfortumab vedotin is applicable in the European Union (EU) Member States, as well as Iceland, Norway and Liechtenstein.

Seagen to Highlight Preclinical Data for Enfortumab Vedotin and Two Novel Antibody-Drug Conjugates at AACR Annual Meeting

2022-04-08 17:19:00

Seagen Inc. announced data from intravesical instillation of enfortumab vedotin (EV) in a non-muscle invasive bladder cancer (NMIBC) preclinical model in addition to preclinical data from SGN-ALPV and SGN-B7H4V, two of its novel antibody-drug conjugates (ADCs) that utilize the company’s proprietary vedotin drug linker technology. These data will be presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place in New Orleans, April 8-13, 2022. Seagen and Astellas Pharma Inc. are co-developing enfortumab vedotin under a 50:50 worldwide development and commercialization collaboration. Enfortumab vedotin demonstrated antitumor activity in preclinical models of non-muscle invasive bladder cancer (NMIBC). Enfortumab vedotin is directed to Nectin-4, which is highly prevalent in NMIBC. Studies with human bladder cancer cells expressing Nectin-4 showed sustained activity under conditions mimicking intravesical dosing and achieved tumor growth inhibition of 97% when administered in an orthotopic xenograft animal model of NMIBC. Intravesical administration of enfortumab vedotin was well tolerated in a good laboratory practice (GLP) study with minimal local and no systemic toxicities at doses up to six-fold the intravenous maximum tolerated dose. The antitumor activity and safety profile seen in these preclinical studies support further investigation of intravesical enfortumab vedotin in this patient population, which is now enrolling in a phase 1 trial, EV-104. SGN-ALPV is a novel ADC designed to target two proteins, ALPP and ALPPL2, to maximize drug delivery. ALPP and ALPPL2 are aberrantly co-expressed in a broad set of solid tumors, including ovarian, endometrial and germ cell cancers. In preclinical studies, SGN-ALPV exhibited robust antitumor activity in cell line and patient-derived xenograft cancer models with both homogenous and heterogeneous expression of placental alkaline phosphatases ALPP and ALPPL2, consistent with robust monomethyl auristatin E (MMAE)-directed cytotoxicity and bystander activity of vedotin ADCs. Importantly, ALPP and ALPPL2 exhibit a highly restricted normal tissue expression, which may enable a favorable safety profile. Differential expression of ALPP and ALPPL2 in the tumor versus normal tissue, antibody specificity, antitumor activity and tolerability of SGN-ALPV provided a strong rationale for the initiation of the first-in-human phase 1 clinical study currently enrolling patients. Enfortumab vedotin-ejfv (PADCEV®) is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.i,ii Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis). SGN-ALPV is a novel, investigational vedotin antibody drug conjugate (ADC) designed to bind and internalize the homodimers (ALPP or ALPPL2) or heterodimers (ALPP/ALPPL2-ADC) complex from the surface of tumor cells and release the microtubule-disrupting agent MMAE, inducing cell cycle arrest and apoptosis. SGN-ALPV has demonstrated highly effective targeting of alkaline phosphatases ALPP and ALPPL2 in preclinical models and will be initially evaluated in ovarian and endometrial cancer, non-small cell lung cancer (NSCLC), gastric cancer, cervical cancer, testicular germ cell tumors and ovarian germ cell tumors where ALPP and ALPPL2 are highly prevalent. SGN-B7H4V is a novel, investigational vedotin ADC directed to the T cell checkpoint ligand, B7-H4. B7-H4 expression is limited on normal tissue and overexpressed on a variety of solid malignancies, including breast, ovarian and endometrial tumors. SGN-B7H4V is designed to bind and internalize the B7-H4/ADC complex from the surface of the tumor cells and release the therapeutic payload MMAE, inducing MMAE-mediated direct cytotoxicity, bystander killing and immunogenic cell death, as well as antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP). SGN-B7H4V demonstrates strong activity in xenograft models, including models with heterogenous B7-H4 expression.

Seagen Inc., Q1 2022 Earnings Call, Apr 28, 2022

2022-04-07 12:00:00

Seagen Inc., Q1 2022 Earnings Call, Apr 28, 2022

Seagen Inc. to Report Q1, 2022 Results on Apr 28, 2022

2022-04-07 12:00:00

Seagen Inc. announced that they will report Q1, 2022 results After-Market on Apr 28, 2022

Seagen Inc. Presents at 12th Annual World ADC Conference 2022, Mar-29-2022 through Mar-31-2022

2022-03-30 09:20:00

Seagen Inc. Presents at 12th Annual World ADC Conference 2022, Mar-29-2022 through Mar-31-2022. Venue: London, United Kingdom. Presentation Date & Speakers: Mar-30-2022, Nicholas Choong, VP, Clinical Development, Shweta Jain, Senior Medical Director. Mar-31-2022, Heather Van Epps, Director, Research Early-Stage Clinical Programs, Shweta Jain, Senior Medical Director.

Hanson Wade Limited, 12th Annual World ADC Conference 2022, Mar 29, 2022 through Mar 31, 2022

2022-03-29 17:52:00

Hanson Wade Limited, 12th Annual World ADC Conference 2022, Mar 29, 2022 through Mar 31, 2022. Venue: London, United Kingdom.

Seagen Inc. Presents at Bank of America 2022 Healthcare Conference, May-10-2022 12:40 PM

2022-03-22 05:03:00

Seagen Inc. Presents at Bank of America 2022 Healthcare Conference, May-10-2022 12:40 PM. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las Vegas, Nevada, United States. Speakers: Clay B. Siegall, Co-Founder, Chairman, President & CEO.

Bank of America Corporation, Bank of America 2022 Healthcare Conference, May 10, 2022 through May 13, 2022

2022-02-17 10:42:00

Bank of America Corporation, Bank of America 2022 Healthcare Conference, May 10, 2022 through May 13, 2022. Venue: Encore Hotel, 3121 Las Vegas Blvd. S, Las Vegas, Nevada, United States.

Seagen Inc. Provides Earnings Guidance for the Year 2022

2022-02-09 21:03:00

Seagen Inc. provided earnings guidance for the year 2022. For the year, the company expects total revenue to range from $1,665 million to $1,745 million.

ADCETRIS® Combination Significantly Improves Overall Survival in Newly Diagnosed Patients with Advanced Hodgkin Lymphoma

2022-02-03 13:00:00

Seagen Inc. announced that the phase 3 ECHELON-1 clinical trial demonstrated a statistically significant improvement in overall survival (OS) (p=0.009) in patients with advanced classical Hodgkin lymphoma (cHL) following treatment with ADCETRIS (brentuximab vedotin) in combination with chemotherapy. With approximately six years median follow up, patients receiving ADCETRIS plus doxorubicin, vinblastine, and dacarbazine (A+AVD) in the frontline setting had a 41 percent reduction in the risk of death (HR 0.59; [95% CI: 0.396 to 0.879]) compared with patients receiving doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). The safety profile of ADCETRIS was consistent with previous studies and no new safety signals were observed. ECHELON-1 is an open-label, international, randomized, phase 3 trial evaluating the safety and efficacy of frontline ADCETRIS plus AVD versus ABVD in 1,334 adult patients with stage III or IV cHL. Patients were randomly assigned to receive A+AVD or ABVD intravenously on days 1 and 15 of each 28-day cycle for up to six cycles. OS is the key secondary endpoint of the trial. The primary endpoint, modified progression free survival, served as the basis for global regulatory approvals. ADCETRIS is approved for certain types of relapsed or refractory Hodgkin lymphoma (HL) including previously untreated Stage III/IV cHL and previously untreated peripheral T-cell lymphoma (PTCL). It has received marketing authorization in more than 75 countries and is being evaluated globally in more than 70 corporate- and investigator-sponsored clinical trials across multiple settings in lymphoma and other diseases.

Seagen Inc. Presents at SCOPE Summit 2022, Feb-07-2022 through Feb-10-2022

2022-02-03 10:27:00

Seagen Inc. Presents at SCOPE Summit 2022, Feb-07-2022 through Feb-10-2022. Venue: Orlanda, Florida, United States. Presentation Date & Speakers: Feb-07-2022, Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations. Feb-08-2022, Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations.

Seagen Inc. Announces Executive Changes

2022-02-01 13:00:00

Seagen Inc. announced the appointment of Lee Heeson as Executive Vice President, Commercial International. Heeson has nearly 30 years of industry experience, and will have responsibility for the continued expansion of Seagen’s Commercial operations in Europe, Canada and the rest of the world outside the United States. He will be a member of Seagen’s Executive Committee and report to Clay Siegall, Ph.D., President and Chief Executive Officer of Seagen. Heeson succeeds Tuomo Pätsi, who will retire effective February 4, 2022. Most recently, Heeson was President of International at Vifor Pharma in Switzerland. Previously, he was President of Worldwide Markets at Celgene following other executive positions at the company. Earlier in his career he held leadership positions at Galderma and Schering-Plough. Heeson will be based at Seagen’s International Headquarters in Zug, Switzerland.

Seagen Inc., Q4 2021 Earnings Call, Feb 09, 2022

2022-01-18 13:00:00

Seagen Inc., Q4 2021 Earnings Call, Feb 09, 2022

Seagen Inc. to Report Q4, 2021 Results on Feb 09, 2022

2022-01-18 13:00:00

Seagen Inc. announced that they will report Q4, 2021 results After-Market on Feb 09, 2022

Astellas and Seagen Receive Positive CHMP Opinion for PADCEV™ (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

2021-12-17 11:40:00

Astellas Pharma Inc. and Seagen Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of the antibody-drug conjugate (ADC) PADCEV™ (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and a PD-1/L1 inhibitor. Urothelial cancer is the most common type of bladder cancer In Europe, an estimated 204,000 people were diagnosed with urothelial cancer in 2020, and more than 67,000 died as a result of the disease. If approved by the European Commission (EC), enfortumab vedotin will be the first ADC authorized in the European Union for people living with advanced urothelial cancer. The CHMP recommendation is based on data from the global phase 3 EV-301 trial, which evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. Results from the trial, which had a primary endpoint of overall survival, were published in the New England Journal of Medicine. The positive opinion from the CHMP will now be reviewed by the EC. EC decisions are valid in the European Union Member States, as well as Iceland, Norway and Liechtenstein. The EV-301 trial (NCT03474107) was a global, multicenter, open-label, randomized phase 3 trial designed to evaluate enfortumab vedotin versus physician's choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in 608 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/L1 inhibitor and platinum-based therapies. The primary endpoint was overall survival and secondary endpoints included progression-free survival, overall response rate, duration of response and disease control rate, as well as assessment of safety/tolerability and quality-of-life parameters.

Seagen Announces Preliminary Results from Phase 2 Clinical Trial of ADCETRIS® (brentuximab vedotin)

2021-12-12 23:00:00

Seagen Inc. announced promising efficacy and safety results from Part B of an open-label, phase 2 clinical trial evaluating ADCETRIS® (brentuximab vedotin) in a novel combination with nivolumab, doxorubicin, and dacarbazine (AN+AD) as a frontline treatment for patients with advanced stage classical Hodgkin lymphoma (cHL). Data from this preliminary analysis were presented (Abstract #2454) as part of a poster presentation at the 63rdAmerican Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta. The preliminary results demonstrated a complete response rate of 88% (95% CI: 75.9, 94.8) and overall response rate of 93% (95% CI: 82.7, 98.0) among 56 patients who had an end of treatment assessment on or prior to the data cutoff date. Patients received up to six cycles of treatment and were evaluated after two cycles of therapy and at the end of treatment. AN+AD was well-tolerated and no new safety signals were observed. Efficacy: Among 56 patients who had an end of treatment assessment on or prior to the data cutoff date, there was a complete response rate of 88% (95% CI: 75.9, 94.8) and overall response rate of 93% (95% CI: 82.7, 98.0). Safety: The most frequently reported treatment-related treatment-emergent adverse events (AEs) occurring in more than 20% of patients who received AN+AD included nausea (65%), fatigue (46%), peripheral sensory neuropathy (39%), alopecia (35%), diarrhea (30%) and constipation (25%); Immune-mediated AEs were observed in 18 patients (32%) and eight patients (14%) experienced treatment-related treatment-emergent serious AEs; Two patients (4%) experienced Grade > 3 peripheral neuropathy and no patients discontinued treatment due to peripheral neuropathy. No febrile neutropenia was observed, and there were no Grade 5 adverse events.

American Society Of Clinical Oncology, Inc., the 2022 ASCO Annual Meeting, Jun 03, 2022 through Jun 07, 2022

2021-12-10 06:32:00

American Society Of Clinical Oncology, Inc., The 2022 ASCO Annual Meeting, Jun 03, 2022 through Jun 07, 2022. Venue: McCormick Place, Chicago, Illinois, United States.

Drug Information Association, Inc., DIA Global Annual Meeting 2022, Jun 19, 2022 through Jun 23, 2022

2021-12-10 06:32:00

Drug Information Association, Inc., DIA Global Annual Meeting 2022, Jun 19, 2022 through Jun 23, 2022. Venue: Chicago, Illinois, United States.

Seagen Announces Updated Results from Pivotal HER2CLIMB Trial Evaluating TUKYSA® (tucatinib)

2021-12-08 23:00:00

Seagen Inc. announced the presentation of new data from exploratory analyses from the pivotal HER2CLIMB trial showing that improvement in overall survival (OS) was maintained after an additional 15.6 months of follow-up when TUKYSA® (tucatinib) was combined with trastuzumab and capecitabine in patients with HER2-positive metastatic breast cancer (MBC) who had stable or active brain metastases. The data were featured in a spotlight poster (Abstract #PD4-04) at the 2021 San Antonio Breast Cancer Symposium (SABCS). After a median follow-up of 29.6 months, the TUKYSA regimen improved OS for patients with brain metastases by 9.1 months compared to trastuzumab and capecitabine alone (21.6 months vs. 12.5 months) (HR: 0.60; [95% CI: 0.44, 0.81]). The benefit extended to patients with active or stable brain metastases.

Seagen Inc. Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference, Dec-01-2021 03:00 PM

2021-11-22 15:06:00

Seagen Inc. Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference, Dec-01-2021 03:00 PM. Venue: New York, New York, United States. Speakers: Roger D. Dansey, Chief Medical Officer, Todd E. Simpson, Chief Financial Officer.

Seagen to Highlight New Data in Advanced Breast Cancer at 2021 San Antonio Breast Cancer Symposium

2021-11-19 14:33:00

Seagen Inc. announced upcoming data presentations for TUKYSA® (tucatinib) at the San Antonio Breast Cancer Symposium (SABCS), taking place December 7-10, 2021. Seven abstracts including three spotlight posters - highlight the company’s commitment to addressing unmet needs in advanced breast cancer. Two abstracts featured in spotlight poster presentations show: Continued Clinical Benefit in HER2-Positive Metastatic Breast Cancer Patients (MBC) with Active and Stable Brain Metastases. Updated exploratory results from the pivotal HER2CLIMB trial showed that TUKYSA combined with trastuzumab and capecitabine resulted in a robust and durable prolongation of overall survival (OS) that was consistent with results from the primary analysis for HER2-positive metastatic breast cancer patients with brain metastases after an additional 15.6 months of follow-up. The benefit was maintained in patients with active and stable brain metastases. These results will be featured in a spotlight poster (Abstract #PD4-04) presented by Nancy U. Lin, M.D., Director of the Metastatic Breast Cancer Program in the Susan F. Smith Center for Women’s Cancers at Dana-Farber in Boston, MA. Promising Activity of TUKYSA Regimen in HER2-Positive MBC Patients with Leptomeningeal Metastases: A single-arm, investigator-sponsored phase 2 trial (n=17) of TUKYSA combined with trastuzumab and capecitabine represents the first prospective evidence of a systemic regimen demonstrating clinical benefit for HER2-positive breast cancer patients with leptomeningeal metastases, cancer that has spread to the membranes lining the brain and spinal cord. The findings showed a median OS of nearly one year (11.9 months [95% Confidence Interval: 4.1, NR]). Patients with leptomeningeal disease have a historically poor prognosis with median survival of four to five months. The most common treatment for leptomeningeal metastases is radiation therapy. These results will be featured in a spotlight poster (Abstract #PD4-02) presented by Rashmi Murthy, M.D., University of Texas MD Anderson Cancer Center. Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. Up to 50% of metastatic HER2-positive breast cancer patients develop brain metastases over time. In 2020, more than two million new cases of breast cancer were diagnosed worldwide. Between 15% and 20% of breast cancer cases are HER2-positive.

Seagen to Highlight Two Novel Antibody-Drug Conjugates (ADCs) at the SITC 36th Annual Meeting

2021-11-09 13:54:00

Seagen Inc. announced the presentation of two new vedotin-based antibody-drug conjugate (ADC) programs at the Society for Immunotherapy of Cancer (SITC) 36th Anniversary Annual Meeting, taking place in Washington, D.C. and virtually, November 10-14, 2021. Each program combines antibodies targeted to an immune checkpoint [PD-(L)1 or B7-H4] with the cytotoxic properties of the vedotin payload. Preclinical data demonstrate promising antitumor activity. Both ADCs are set to enter first-in-human phase 1 studies in 2022. SGN-PDL1V is a novel, investigational vedotin ADC directed to the T cell checkpoint ligand, PD-(L)1. PD-(L)1 is a target with limited normal tissue expression and clinically validated expression across a variety of malignancies, including non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinomas (HNSCC). SGN-PDL1V is engineered for efficient delivery of the therapeutic payload, monomethyl auristatin E (MMAE), and is proposed to have distinct mechanisms of action from other PD-(L)1-directed therapeutics, including direct cytotoxicity against PD-(L)1-expressing cells, bystander killing, and immunogenic cell death. SGN-PDL1V demonstrates robust antitumor activity in xenograft models, including in tumors with low, heterogenous PD-(L)1 expression, supporting the potential to treat patients across a wide range of PD-(L)1 expression levels. (Abstract #783); SGN-B7H4V is a novel, investigational vedotin ADC directed to the T cell checkpoint ligand, B7-H4. B7-H4 expression is limited on normal tissue and overexpressed on a variety of solid malignancies, including breast, ovarian, and endometrial tumors. SGN-B7H4V is designed to bind and internalize the B7-H4/ADC complex from the surface of the tumor cells and release the therapeutic payload MMAE, inducing MMAE-mediated direct cytotoxicity, bystander killing, and immunogenic cell death, as well as antibody-dependent cellular cytoxicity (ADCC) and phagocytosis (ADCP). SGN-B7H4V demonstrates strong activity in xenograft models, including models with heterogenous B7-H4 expression.

Seagen Inc. to Highlight Multiple ADCETRIS® (brentuximab vedotin) Data Presentations at the Upcoming 2021 American Society of Hematology (ASH) Annual Meeting

2021-11-04 13:31:00

Seagen Inc. announced that new data for ADCETRIS® (brentuximab vedotin), including five oral presentations, will be featured at the upcoming 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 11-14, 2021. Data presentations will include updated safety and efficacy results from clinical trials examining the potential of ADCETRIS with novel combinations in patients with advanced stage classical Hodgkin lymphoma (HL), in patients with newly diagnosed CD30-expressing peripheral T-cell lymphoma (PTCL) and in patients with other histologies. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and expressed on the surface of several types of PTCL. ADCETRIS is approved in more than 75 countries for relapsed or refractory HL and systemic anaplastic large cell lymphoma (sALCL).

SVB Leerink LLC, 11th SVB Leerink Annual Global Healthcare Conference 2022, Feb 14, 2022 through Feb 18, 2022

2021-10-29 14:57:00

SVB Leerink LLC, 11th SVB Leerink Annual Global Healthcare Conference 2022, Feb 14, 2022 through Feb 18, 2022. Venue: New York, New York, United States.

Seagen Inc. Presents at TIGIT Therapies Digital Summit, Dec-07-2021

2021-10-12 17:24:00

Seagen Inc. Presents at TIGIT Therapies Digital Summit, Dec-07-2021 . Speakers: Alyson Smith, Associate Director, Shyra Gardai, Executive Director & Head of Immunology.

Seagen Inc. and Astellas Pharma Inc. Complete Enrollment in EV-103 Trial Cohort K Combining Padcev (Enfortumab Vedotin-Ejfv) with Pembrolizumab as First-Line Treatment for Advanced Urothelial Cancer

2021-10-12 12:00:00

Seagen Inc. and Astellas Pharma Inc. announced that patient enrollment was completed in Cohort K of the phase 1b/2 EV-103 clinical trial (also known as KEYNOTE-869). The cohort is evaluating PADCEV (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. Merck is known as MSD outside the United States and Canada. EV-103 is a multi-cohort, open-label, multicenter phase 1b/2 trial of PADCEV alone or in combination, evaluating safety, tolerability and efficacy in muscle invasive bladder cancer and in locally advanced or metastatic urothelial cancer in first- or second-line settings. Key outcome measures of EV-103 Cohort K are objective response rate (ORR) per blinded independent central review (BICR) using RECIST 1.1 and duration of response (DoR). The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation in February 2020 for PADCEV in combination with KEYTRUDA for patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. The designation is based on results from the dose-escalation cohort and expansion cohort A of the EV-103 trial.

Hanson Wade Limited, TIGIT Therapies Digital Summit, Dec 07, 2021 through Dec 09, 2021

2021-10-12 06:21:00

Hanson Wade Limited, TIGIT Therapies Digital Summit, Dec 07, 2021 through Dec 09, 2021.

Seagen Inc. Presents at Festival of Biologics Basel 2021, Nov-09-2021 09:10 AM

2021-10-11 18:52:00

Seagen Inc. Presents at Festival of Biologics Basel 2021, Nov-09-2021 09:10 AM. Venue: Congress Centre, Basel, Switzerland. Speakers: Peter D. Senter, Vice President of Chemistry and Distinguished Fellow.

Seagen Inc. to Report Q3, 2021 Results on Oct 28, 2021

2021-10-07 12:00:00

Seagen Inc. announced that they will report Q3, 2021 results After-Market on Oct 28, 2021

Seagen Inc., Q3 2021 Earnings Call, Oct 28, 2021

2021-10-07 12:00:00

Seagen Inc., Q3 2021 Earnings Call, Oct 28, 2021

Seagen Inc. Presents at Antibody Engineering & Therapeutics US, Dec-12-2021 through Dec-17-2021

2021-10-06 12:38:00

Seagen Inc. Presents at Antibody Engineering & Therapeutics US, Dec-12-2021 through Dec-17-2021. Venue: Marriott Marquis San Diego, San Diego, California, United States. Presentation Date & Speakers: Dec-16-2021, Peter D. Senter, Vice President of Chemistry and Distinguished Fellow, Shyra Gardai, Executive Director & Head of Immunology.

Seagen Inc. Announces Last Patient Enrolled in Phase 2 MOUNTAINEER Trial Evaluating TUKYSA® (Tucatinib) Regimen in HER2-Positive Metastatic Colorectal Cancer

2021-09-28 12:00:00

Seagen Inc. announced it completed patient enrollment in the phase 2 open-label MOUNTAINEER clinical trial, evaluating TUKYSA® (tucatinib) in combination with trastuzumab (Herceptin®) and as a single agent in patients with HER2-positive (HER2+) metastatic colorectal cancer (mCRC) following previous treatment with first- and second-line standard-of-care therapies. Early results from the MOUNTAINEER trial were presented at the European Society for Medical Oncology (ESMO) 2019 Congress and showed encouraging anti-tumor activity with a well-tolerated safety profile.

Japan’s MHLW Approves Astellas Pharma Inc. and Seagen Inc.'s PADCEV (enfortumab vedotin) for Advanced Urothelial Cancer

2021-09-27 07:00:00

Astellas Pharma Inc. and Seagen Inc. announced that Japan'sMinistry of Health, Labour and Welfare (MHLW) has approved PADCEV (enfortumab vedotin) for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy. The New Drug Application received priority review. The approval is primarily based on the global Phase 3 EV-301 clinical trial, which included sites in Japan. The trial evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. At the time of pre-specified interim analysis, patients who received enfortumab vedotin (n=301) in the trial lived a median of 3.9 months longer than those who received chemotherapy (n=307). Median overall survival was 12.9 vs. 9.0 months, respectively [Hazard Ratio=0.70 (95% Confidence Interval [CI]: 0.56, 0.89), p=0.001]. The most common (=20%) adverse reactions included alopecia, peripheral sensory neuropathy, pruritus, fatigue, decreased appetite, diarrhea, dysgeusia and nausea. Each year in Japan, more than 24,300 people are diagnosed with bladder cancer and an estimated 9,500 die from the disease.1 Enfortumab vedotin is the subject of a robust clinical development program aimed at addressing unmet needs across the continuum of urothelial cancer and in other solid tumors. The EV-301 trial (NCT03474107) was a global, multicenter, open-label, randomized Phase 3 trial designed to evaluate enfortumab vedotin versus physician's choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in 608 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/L1 inhibitor and platinum-based therapies. The primary endpoint was overall survival, and secondary endpoints included progression-free survival, overall response rate, duration of response and disease control rate, as well as assessment of safety/tolerability and quality-of-life parameters. Results were published in the New England Journal of Medicine. Enfortumab vedotin is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.3,4 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).4 PADCEV is co-developed by Astellas and Seagen.

U.S. Food and Drug Administration Grants Approval to TIVDAK

2021-09-21 10:11:00

Seagen Inc. and Genmab A/S announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TIVDAK™ (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is approved under the FDA’s Accelerated Approval Program based on tumor response and the durability of the response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. In the innovaTV 204 clinical trial, TIVDAK was evaluated in 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Results from the trial showed a 24% confirmed objective response rate (ORR) (95% CI; 15.9-33.3), as assessed by an independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. The median duration of response (DOR) was 8.3 months (95% CI; 4.2 to not reached).

Seagen Inc. - Special Call

2021-09-20 21:05:00

To discuss the U.S. Food and Drug Administration approval of TIVDAK™ (tisotumab vedotin-tftv)

Seagen Inc. and Genmab A/S Announce FDA Accelerated Approval for TIVDAK™ (Tisotumab Vedotin-Tftv) in Previously Treated Recurrent or Metastatic Cervical Cancer

2021-09-20 21:00:00

Seagen Inc. and Genmab A/S announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TIVDAK™ (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is approved under the FDA’s accelerated approval program based on tumor response and the durability of the response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. In the innovaTV 204 clinical trial, TIVDAK was evaluated in 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Results from the trial showed a 24% confirmed objective response rate (ORR) (95% CI; 15.9-33.3), as assessed by an independent review committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. The median duration of response (DOR) was 8.3 months (95% CI; 4.2 to not reached). The prescribing information for TIVDAK includes a BOXED WARNING for ocular toxicity, and Warnings for peripheral neuropathy, hemorrhage, pneumonitis, and embryo-fetal toxicity. The most common (=25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (52%), fatigue (50%), lymphocytes decreased (42%), nausea (41%), peripheral neuropathy (39%), alopecia (39%), epistaxis (39%), conjunctival adverse reactions (37%), hemorrhage (32%), leukocytes decreased (30%), creatinine increased (29%), dry eye (29%), prothrombin international normalized ratio increased (26%), activated partial thromboplastin time prolonged (26%), diarrhea (25%), and rash (25%). Please see Important Safety Information below. The Biologics License Application (BLA) for TIVDAK was submitted in February 2021 and accepted with Priority Review in April 2021. The submission was based on the results of the innovaTV 204 trial. The FDA’s Accelerated Approval Program allows for approval of a medicine based on a surrogate endpoint that is reasonably likely to predict clinical benefit, if the medicine fills an unmet medical need for a serious condition. A global, randomized phase 3 clinical trial (innovaTV 301) is underway and is also intended to support global registrations.

Seagen and Genmab Present Interim Results From the innovaTV 205 Study for Tisotumab Vedotin Combination Therapy Treatment of Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2021

2021-09-19 15:30:00

Seagen Inc. and Genmab A/S presented interim data from two cohorts of the phase 1b/2 innovaTV 205 multi-cohort, open-label trial of tisotumab vedotin in recurrent or metastatic cervical cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2021 as part of a featured mini oral presentation. Initial results from these two dose expansion cohorts of the study showed encouraging and durable anti-tumor activity with tisotumab vedotin in combination with carboplatin (Cohort D) as first-line therapy for patients with advanced cervical cancer who had not received prior systemic therapy, with a 55% objective response rate (ORR) and with tisotumab vedotin in combination with pembrolizumab (Cohort F) for patients with advanced cervical cancer who experienced disease progression after 1-2 lines of prior systemic therapy, with a 38% ORR. Both combinations demonstrated a manageable and acceptable safety profile, with no new safety signals identified. 1L TV + Carbo Dose Expansion Cohort Interim Results Within this cohort, recurrent or metastatic cervical cancer patients who had not received any prior systemic therapy were given the recommended phase 2 dose of tisotumab vedotin 2.0 mg/kg plus carboplatin AUC 5 Q3W. Efficacy: The primary endpoint of ORR was 55% (n=18/33 patients), with four patients achieving complete responses and 14 patients achieving partial responses. Median time to response was 1.4 months (range 1.1-4.4), with median follow up of 7.9 months and median duration of response of 8.3 months (95% CI: 4.2-NR). Median progression-free survival (PFS) was 9.5 months (95% CI: 4.0-NR). Safety: Grade =3 adverse events (AE) occurred in 78.8% of patients (n=26/33), with 57.6% (n=19/33) of patients experiencing Grade =3 AEs related to treatment with tisotumab vedotin. Adverse events of special interest (AESI) included ocular events (Grade 1-2: 57.6%; Grade =3: 9.1%), bleeding (Grade 1-2: 51.5%; Grade =3: 6.1%) and peripheral neuropathy (Grade 1-2: 48.5; Grade =3: 12.1%). 2L/3L TV + Pembro Dose Expansion Cohort Results Interim Results Within this cohort, recurrent or metastatic cervical cancer patients who had received 1-2 prior systemic therapies were given the recommended phase 2 dose of tisotumab vedotin 2.0 mg/kg plus pembrolizumab 200 mg Q3W. Efficacy: The primary endpoint of ORR was 38% (n=13/34 patients), with two patients achieving complete responses and 11 patients achieving partial responses. Median time to response was 1.4 months (range 1.3-5.8), with median follow-up of 13.0 months and a median duration of response of 13.8 months (95% CI: 2.8-NR). Median PFS was 5.6 months (95% CI: 2.7-13.7). Safety: Grade =3 AEs occurred in 74.3% of patients (n=26/35), with 45.7% (n=16/35) of patients experiencing Grade =3 AEs related to treatment with tisotumab vedotin. AESI included ocular events (Grade 1-2: 51.4%; Grade =3: 2.9%), bleeding (Grade 1-2: 57.1%; Grade =3: 8.6%) and peripheral neuropathy (Grade 1-2: 37.1%; Grade =3: 2.9%), with one patient experiencing a Grade 4 bleeding event.

Seagen Inc. Presents at 2021 Veeva R&D and Quality Summit Connect, Oct-14-2021

2021-09-14 11:35:00

Seagen Inc. Presents at 2021 Veeva R&D and Quality Summit Connect, Oct-14-2021. Presentation Date & Speakers: Oct-14-2021, Muralikrishnan Sundararajan, Senior Director, IT Business Application Management, Predrag Denkovski, Executive Director, Regulatory Operations, Scott Caparelli, Senior Regulatory Information Management Specialist, Verchel Wunpheng, Sr Manager, Regulatory Information Management.

Veeva Systems Inc., 2021 Veeva R&D and Quality Summit Connect, Oct 14, 2021

2021-09-14 11:03:00

Veeva Systems Inc., 2021 Veeva R&D and Quality Summit Connect, Oct 14, 2021.

Seagen Inc. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-13-2021 02:00 PM

2021-09-09 12:00:00

Seagen Inc. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-13-2021 02:00 PM. Venue: New Windsor, United States.

Seagen Inc. Presents at BioProcess International Conference & Exhibition, Sep-20-2021

2021-09-08 22:27:00

Seagen Inc. Presents at BioProcess International Conference & Exhibition, Sep-20-2021 . Speakers: Shanta Boddapati, Senior Scientist.

Informa plc, BioProcess International Conference & Exhibition, Sep 20, 2021 through Sep 30, 2021

2021-09-08 21:27:00

Informa plc, BioProcess International Conference & Exhibition, Sep 20, 2021 through Sep 30, 2021.

Cambridge Innovation Institute, LLC, SCOPE Summit 2022, Feb 07, 2022 through Feb 10, 2022

2021-09-04 12:00:00

Cambridge Innovation Institute, LLC, SCOPE Summit 2022, Feb 07, 2022 through Feb 10, 2022. Venue: Orlanda, Florida, United States.

Seagen Inc. Presents at European Society for Medical Oncology Virtual Congress 2021, Sep-16-2021

2021-08-23 12:06:00

Seagen Inc. Presents at European Society for Medical Oncology Virtual Congress 2021, Sep-16-2021 . Venue: Paris Expo Porte de Versailles, Paris, France.

Seagen Inc. and RemeGen Co., Ltd. Announces Exclusive Worldwide License and Co-Development Agreement for Disitamab Vedotin

2021-08-09 10:00:00

Seagen Inc. and RemeGen Co., Ltd. announced that the two companies have entered into an exclusive worldwide licensing agreement to develop and commercialize disitamab vedotin, a novel HER2-targeted ADC. Disitamab vedotin combines the drug-linker technology originally developed by Seagen with RemeGen’s novel HER2 antibody exhibiting higher affinity and an increased internalization rate as compared to trastuzumab in preclinical models. As monotherapy, disitamab vedotin has demonstrated antitumor activity in clinical trials in several solid tumor types, including urothelial, gastric and breast cancer, as well as across a spectrum of HER2 expression levels. In addition, promising combination activity was demonstrated with a PD-1 inhibitor in urothelial cancer. It is believed that vedotin-based immunogenic cell death (ICD) may differentiate this class of ADC’s when combined with checkpoint inhibitors. Disitamab vedotin received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation in 2020 for use in second-line treatment of patients with HER2-expressing, locally advanced or metastatic urothelial cancer (mUC) who have previously received platinum-containing chemotherapy. In the same year, RemeGen announced FDA’s clearance of an Investigational New Drug (IND) application for a Phase II clinical trial in mUC. Disitamab vedotin is conditionally approved for treating locally advanced metastatic gastric cancer in China, and in July 2021 the National Medical Products Administration (NMPA) of China also accepted a New Drug Application for disitamab vedotin in mUC. Under the terms of the agreement, Seagen will make a $200 million upfront payment to exclusively license rights to disitamab vedotin for global development and commercialization, outside of RemeGen’s territory. RemeGen will retain development and commercialization rights for Asia, excluding Japan and Singapore. Seagen will lead global development and RemeGen will fund and operationalize the portion of global clinical trials attributable to its territory. RemeGen will also be responsible for all clinical development and regulatory submissions specific to its territory. Seagen will pay RemeGen up to $2.4 billion in potential total milestone payments based upon the achievement of specified development, regulatory and commercialization goals across multiple indications and products. RemeGen will be entitled to a tiered, high single digit to mid-teen percentage royalty based on net sales of disitamab vedotin in Seagen’s territory. Disitamab vedotin is a novel ADC that selectively delivers the anti-cancer agent monomethyl auristatin E (MMAE) into HER2-expressing tumor cells. The novel antibody component of the ADC exhibits a higher affinity and increased internalization rate as compared to trastuzumab in preclinical models, and in animal models, demonstrates promising antitumor activity. It is the first domestically developed ADC in China to receive marketing approval. In June 2021, disitamab vedotin received conditional approval by the NMPA of China to treat locally advanced or metastatic gastric cancer (GEJ carcinoma). In July 2021, the NMPA accepted the New Drug Application for disitamab vedotin in locally advanced or metastatic urothelial carcinoma. In addition, disitamab vedotin has shown significant antitumor activity in clinical trials of a number of HER2-expressing cancers, including those with low HER2 expression. It is currently being studied in multiple late-stage clinical trials across several solid tumor types.

Seagen Inc. Provides Earnings Guidance for 2021

2021-07-29 20:02:00

Seagen Inc. provided earnings guidance for 2021. For the period, the company expects revenues in the range of $675 million to $700 million.

Seagen Inc. Enters into A Commercial Supply Agreement Hovione FarmaCiencia SA

2021-07-15 20:23:00

Seagen Inc. entered into a commercial supply agreement dated as of July 1, 2021 with Hovione FarmaCiencia SA to manufacture tucatinib spray-dried dispersion or drug product intermediate (“Product”) for TUKYSA®. The Agreement provides that the Company will purchase Product pursuant to rolling forecasts and will purchase a minimum percentage of its requirements for Product from Hovione. The Agreement will remain in effect for an initial five-year term, followed by successive automatic two-year renewals. Either party may terminate the Agreement by written notice prior to commencement of the applicable renewal term. In addition, either party has the right to terminate the Agreement if the other party breaches the Agreement and does not remedy the breach after written notice or if the occurrence of a force majeure event prevents the other party from performing its obligations under the Agreement. The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by the terms and conditions of the Agreement, which will be filed as an exhibit to the Company’s quarterly report on Form 10-Q for the quarter ending September 30, 2021.

Seagen Inc. and Astellas Pharma Inc. Announces the U.S. Food and Drug Administration Granted PADCEV

2021-07-09 18:10:00

Seagen Inc. and Astellas Pharma Inc. announced the U.S. Food and Drug Administration (FDA) granted PADCEV® (enfortumab vedotin-ejfv) regular approval in the U.S., in addition to approving a new indication for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. Cisplatin-ineligible patients typically have limited treatment options and a poor prognosis. In 2019, the FDA granted accelerated approval for PADCEV for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery, or in a locally advanced or metastatic urothelial cancer setting. The conversion from accelerated approval to regular approval and the label expansion were based on two supplemental Biologics License Applications (sBLAs) reviewed under the Real-Time Oncology Review (RTOR) pilot program. The EV-301 trial compared PADCEV to chemotherapy in adult patients (n=608) with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. At the time of pre-specified interim analysis, patients who received PADCEV (n=301) in the trial lived a median of 3.9 months longer than those who received chemotherapy (n=307). Median overall survival was 12.9 vs. 9.0 months, respectively [Hazard Ratio=0.70 (95% Confidence Interval [CI]: 0.56, 0.89), p=0.001]. The most common all-grade adverse reactions (=20%) included rash, fatigue, peripheral neuropathy, alopecia, decreased appetite, diarrhea, pruritus, nausea, constipation, dysgeusia, musculoskeletal pain, dry eye, pyrexia, abdominal pain and anemia. Cohort 2 of the EV-201 trial evaluated PADCEV in patients (n=89) with locally advanced or metastatic urothelial cancer who had been previously treated with a PD-1/L1 inhibitor, had not received a platinum-containing chemotherapy in this setting, and were ineligible for cisplatin. After a median follow-up of 16 months, 51% of patients who received PADCEV had an objective response [95% CI: 39.8, 61.3] per blinded independent central review, with a median duration of response of 13.8 months [95% CI: 6.4, not reached]. The most common all-grade adverse reactions (=20%) included rash, peripheral neuropathy, alopecia, fatigue, decreased appetite, anemia, diarrhea, pruritus, weight decreased, nausea, dry eye and dysgeusia. Globally, approximately 573,000 new cases of bladder cancer and more than 212,000 deaths are reported annually.1 PADCEV is the subject of a robust development program aimed at addressing unmet needs across the continuum of urothelial cancer and in other solid tumors. The FDA’s RTOR program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible. The agency’s review was also conducted as part of Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among participating international health authorities. Through Project Orbis, health authorities in Australia and Canada are continuing to review data from EV-301 and EV-201 for initial registrations. About the EV-301 Trial: The EV-301 trial (NCT03474107) is a global, multicenter, open-label, randomized phase 3 trial designed to evaluate enfortumab vedotin versus physician's choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in 608 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/L1 inhibitor and platinum-based therapies.2 The primary endpoint is overall survival and secondary endpoints include progression-free survival, overall response rate, duration of response and disease control rate, as well as assessment of safety/tolerability and quality-of-life parameters. About the EV-201 Trial: The EV-201 trial (NCT03219333) is a single-arm, multi-cohort, multicenter, pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1 or PD-L1 inhibitor, including those who have also been treated with a platinum-containing chemotherapy (Cohort 1) and those who have not received a platinum-containing chemotherapy in this setting and who are ineligible for cisplatin (Cohort 2). The trial enrolled 125 patients in Cohort 1 and 89 patients in Cohort 2 at multiple centers internationally.3 The primary endpoint is confirmed objective response rate per blinded independent central review. Secondary endpoints include assessments of duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability. Results of Cohort 2 were published in the Lancet Oncology.

Seagen Inc. to Report Q2, 2021 Results on Jul 29, 2021

2021-07-08 12:00:00

Seagen Inc. announced that they will report Q2, 2021 results After-Market on Jul 29, 2021

Seagen Inc., Q2 2021 Earnings Call, Jul 29, 2021

2021-07-08 12:00:00

Seagen Inc., Q2 2021 Earnings Call, Jul 29, 2021