Seagen to Highlight Research From 16 Presentations Across Multiple Tumor Types at ESMO 2021

Rhea-AI Summary

Seagen Inc. announced data from ongoing trials will be presented at the ESMO 2021 Annual Meeting, highlighting the safety and efficacy of tisotumab vedotin in treating recurrent or metastatic cervical cancer. Key presentations include interim analyses of tisotumab vedotin combined with chemotherapy. The FDA is currently reviewing Seagen’s Biologics License Application for tisotumab vedotin, with a target action date of October 10, 2021. The company remains committed to transforming cancer treatment through innovative therapies.

Positive

• Presentation of important clinical data at ESMO 2021 highlights Seagen's commitment to cancer research.
• Tisotumab vedotin is under Priority Review by the FDA, suggesting potential for expedited approval.

Negative

• Potential risks remain due to the possibility of adverse events or safety signals in clinical trials.
• The company faces uncertainties regarding regulatory actions which may affect product development timelines.

- 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 -

BOTHELL, Wash.--(BUSINESS WIRE)-- 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 Author	Presentation Type
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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210908005295/en/

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

Source: Seagen Inc.

FAQ

What is the significance of the data presented by Seagen at ESMO 2021?

The data showcases the safety and efficacy of tisotumab vedotin for recurrent or metastatic cervical cancer, indicating potential advancements in treatment options.

When is the FDA expected to make a decision on the tisotumab vedotin application?

The FDA has a target action date set for October 10, 2021, regarding the Biologics License Application for tisotumab vedotin.

What types of cancer therapies is Seagen focusing on?

Seagen is focusing on antibody-drug conjugates and innovative therapies aimed at various cancers, including cervical and urothelial carcinoma.

What are the key presentations from Seagen at ESMO 2021?

Key presentations include interim results from the innovaTV 205 trial evaluating tisotumab vedotin in combination with carboplatin and pembrolizumab.

How does Seagen plan to impact cancer treatment?

Seagen aims to transform cancer treatment through the development of innovative therapies addressing significant unmet medical needs.