- Data from Phase 1/2 innovaTV 205 Trial Evaluating Tisotumab Vedotin Combination Therapy in Recurrent or Metastatic Cervical Cancer to be Featured in Mini Oral Presentation -
Seagen Inc. (Nasdaq: SGEN) today announced data and trials in progress from its diverse and growing portfolio of marketed and investigational therapies will be presented at the virtual European Society for Medical Oncology (ESMO) 2021 Annual Meeting, to be held from September 16-21. Sixteen presentations will demonstrate the breadth of Seagen’s portfolio and development activities, across multiple cancer types - including a mini oral presentation featuring results from the Phase 1/2 innovaTV 205 clinical trial in recurrent or metastatic cervical cancer.
The innovaTV 205 trial of tisotumab vedotin (TV) is designed to evaluate the safety and efficacy of TV as monotherapy and in combination with chemotherapy and other agents in recurrent or metastatic cervical cancer. Data to be shared will include interim analyses of TV plus carboplatin as a potential first-line therapy, as well as analyses of TV plus pembrolizumab in previously treated patients.
Seagen’s Biologics License Application for TV monotherapy in recurrent or metastatic cervical cancer is currently under Priority Review by the U.S. Food and Drug Administration (FDA) with a target action date of Oct. 10, 2021.
“The data to be shared at ESMO 2021 reflect our commitment to developing transformational cancer medicines for patients in areas of significant unmet medical need, including best-in-class antibody-drug conjugates,” said Roger Dansey, M.D., Chief Medical Officer at Seagen. “Our research to advance antibody-drug conjugates as monotherapies or in combination with other therapies for the treatment of various cancers has the potential to shape future treatment paradigms.”
Other research presentations include subset analyses of EV-301, a phase 3 trial of enfortumab vedotin (EV) versus chemotherapy for previously treated advanced urothelial carcinoma, and the first data from a weekly-dosing trial of ladiratuzumab vedotin (LV), an investigational anti-LIV-1 antibody-drug conjugate, in pre-treated metastatic triple-negative breast cancer.
Data to be presented at ESMO 2021 for Seagen medicines and investigational agents:
Presentation # |
Abstract Title |
Lead
|
Presentation
|
Tisotumab Vedotin |
|||
723MO |
Tisotumab Vedotin (TV) + Carboplatin (Carbo) in First-line (1L) or + Pembrolizumab (Pembro) in Previously Treated (2L/3L) Recurrent or Metastatic Cervical Cancer (r/mCC): Interim Results of ENGOT-Cx8/GOG-3024/innovaTV 205 Study |
I. Vergote |
Mini Oral Session – Gynaelogical Cancers, Sunday, September 19, 5:30-5:35 PM CEST |
930TiP |
innovaTV 207: New Dosing Cohort in the Open Label Phase 2 Study of Tisotumab Vedotin in Solid Tumors |
D. Hong |
On Demand E-Poster |
PADCEV® (enfortumab vedotin) |
|||
698P |
Analysis of hard-to-treat subgroups from EV-301, a phase 3 trial of enfortumab vedotin (EV) vs chemotherapy for previously treated advanced urothelial carcinoma |
J. Rosenberg |
On Demand E-Poster |
705P |
Systematic literature review (SLR) and network meta-analysis (NMA) of first-line (1L) therapies for locally advanced/metastatic urothelial carcinoma (la/mUC) |
L. Bloudek |
On Demand E-Poster |
704P |
Treatment Patterns Among Patients with Advanced Urothelial Carcinoma (aUC) in the US |
A. Morgans |
On Demand E-Poster |
TUKYSA® (tucatinib) |
|||
331TiP |
HER2CLIMB-04: Phase 2 Trial of Tucatinib + Trastuzumab Deruxtecan in Patients With HER2+ Locally Advanced or Metastatic Breast Cancer With and Without Brain Metastases (Trial in Progress) |
L. Carey |
On Demand E-Poster |
1434TiP |
MOUNTAINEER-02: Phase 2/3 study of tucatinib, trastuzumab, ramucirumab, and paclitaxel in previously treated HER2+ gastric or gastroesophageal junction adenocarcinoma (GEC): Trial in Progress |
D. Catenacci |
On Demand E-Poster |
557TiP |
SGNTUC-019: Phase 2 basket study of tucatinib and trastuzumab in previously treated solid tumors with HER2 alterations (Trial in Progress) |
M. Reck |
On Demand E-Poster |
1437TiP |
Phase 1b/2, open label, dose escalation and expansion trial of tucatinib in combination with trastuzumab and oxaliplatin-based chemotherapy in patients with unresectable or metastatic HER2+ gastrointestinal cancers (Trial in Progress) |
H. Park |
On Demand E-Poster |
439P |
Characteristics and treatment patterns among patients with HER2-amplified advanced/metastatic colorectal cancer (mCRC): a clinical-genomic database study |
J. Strickler |
On Demand E-Poster |
Ladiratuzumab Vedotin |
|||
259P |
Weekly ladiratuzumab vedotin monotherapy for metastatic triple negative breast cancer |
M. Tsai |
On Demand E-Poster |
643TiP |
Open-Label, Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors (SGNLVA-005, Trial in Progress) |
HT. Arkenau |
On Demand E-Poster |
ADCETRIS® (brentuximab vedotin) |
|||
1029TiP |
Phase 2 Trial of Pembrolizumab (Pembro) and Brentuximab Vedotin (BV) in Patients With Metastatic Solid Malignancies After Progression on Prior Programmed Cell Death Protein (PD)-1 Inhibitors (SGN35-033, Trial in Progress) |
C. Lance Cowey |
On Demand E-Poster |
Early Pipeline |
|||
555TiP |
A First-in-Human Trial of the Integrin Beta-6-Targeted Antibody–Drug Conjugate, SGN-B6A, in Patients With Advanced Solid Tumors (SGNB6A-001, Trial in Progress) |
E. Calvo |
On Demand E-Poster |
556TiP |
A Phase 1 Study of SGN-STNV, a Novel Antibody–Drug Conjugate Targeting Sialyl-Thomsen-nouveau Antigen (STn), in Adults With Advanced Solid Tumors (SGNSTNV-001) |
N. Lakhani |
On Demand E-Poster |
558TiP |
Phase 1 Study of Effector-function Enhanced Monoclonal Antibody (mAb), SEA-TGT, in Advanced Malignancies (SGNTGT-001, Trial in Progress) |
V. Ribrag |
On Demand E-Poster |
About Seagen
Seagen Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people’s lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on our marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.
Forward Looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of Seagen’s products and product candidates, the company’s pipeline and the advancement of its research and development activities. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include without limitation the risk of adverse events or safety signals, the inability to show sufficient activity in clinical trials, the possibility of adverse regulatory actions, and the potential for delays or setbacks in product development and the regulatory review process. More information about the risks and uncertainties faced by the company is contained under the caption “Risk Factors” included in Seagen’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise except as required by applicable law.
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Contacts
For Media
David Caouette
Vice President, Corporate Communications
(310) 430-3476
dcaouette@seagen.com
For Investors
Peggy Pinkston
Senior Vice President, Investor Relations
(425) 527-4160
ppinkston@seagen.com
