On August 27, 2020 Genmab A/S (Nasdaq: GMAB) reported that results from the phase 2 innovaTV 204 study evaluating tisotumab vedotin in patients with recurrent or metastatic cervical cancer will be presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Genmab, AUG 27, 2020, View Source [SID1234564050]). The abstract is scheduled to be available on Sep 19, 2020 and will be published online via the ESMO (Free ESMO Whitepaper) website.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are very pleased that the innovaTV 204 study is selected as a late-breaking oral presentation at ESMO (Free ESMO Whitepaper)," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "There is a high unmet need for treatment options for women with advanced cervical cancer, following disease progression on standard-of-care therapy. Genmab and Seattle Genetics have a shared commitment to transform the treatment of advanced cervical cancer and we look forward to presenting the promising results from the innovaTV 204 study at this prestigious conference."
ESMO Oral Presentation Details
Title: Tisotumab vedotin in previously treated recurrent or metastatic cervical cancer: results from the phase 2 innovaTV 204/GOG-3023/ENGOT-cx6 study
Number: LBA32 | Channel: 3
Presenter: Robert L. Coleman, MD, FACOG, FACS, US Oncology Research, The Woodlands, Texas, USA
Date and Session: Monday, Sep 21, 2020, Proffered Paper 2 – Gynaecological cancers
Time: Lecture – 17:04 – 17:16 CEST | Live Q&A – 17:38 – 17:48 CEST
A trial in progress abstract, titled, "innovaTV 208: New weekly dosing cohort in the phase 2 study of tisotumab vedotin in platinum-resistant ovarian cancer" (882TiP) will be presented as a poster presentation on Thursday, Sep 17, 2020.
About innovaTV 204 Trial
The innovaTV 204 trial (also known as GCT1015-04 or innovaTV 204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with or without bevacizumab if eligible per local standards. Patients were eligible if they had received up to two prior lines of therapy in the recurrent/metastatic setting. In the study operationalized by Genmab, 101 patients were treated with tisotumab vedotin at multiple centers in Europe and the U.S. The primary endpoint of the trial was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by independent central review. Key secondary endpoints included duration of response, time to response, progression-free survival, overall survival, safety and tolerability.
The study was conducted by Genmab in collaboration with Seattle Genetics Inc., European Network of Gynaecological Oncological Trial groups (ENGOT) and Gynecologic Oncology Group (GOG). For more information about the Phase 2 innovaTV 204/GOG-3023/ENGOT-cx6 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.
About Tisotumab Vedotin
Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) composed of Genmab’s fully human monoclonal antibody specific for tissue factor and Seattle Genetics’ ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody and releases it upon internalization, inducing target cell death. In cancer biology, tissue factor is a protein that can promote tumor growth, angiogenesis and metastasis.1 Based on its high expression on many solid tumors and its rapid internalization, tissue factor was selected as a target for an ADC approach. Tisotumab vedotin is being co-developed by Genmab and Seattle Genetics, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.
Tisotumab vedotin is being evaluated in ongoing clinical trials as a monotherapy in a range of solid tumors and in recurrent and/or metastatic cervical cancer in combination with commonly used therapies. These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule.