Copenhagen, Denmark, Aug 27, 2020
Genmab A/S (Nasdaq: GMAB) announced today 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) Virtual Congress 2020. The abstract is scheduled to be available on Sep 19, 2020 and will be published online via the ESMO website.
"We are very pleased that the innovaTV 204 study is selected as a late-breaking oral presentation at ESMO," 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 TrialThe 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.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of the following approved antibodies: DARZALEX® (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Kesimpta® (subcutaneous ofatumumab, under agreement with Novartis AG), for the treatment of adults with relapsing forms of multiple sclerosis in the U.S. and TEPEZZA® (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. The first approved Genmab created therapy, Arzerra® (ofatumumab, under agreement with Novartis AG), approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan and is also available in other territories via compassionate use or oncology access programs. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, the HexaBody® platform, which creates effector function enhanced antibodies, the HexElect® platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody® platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
This Media Release contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on www.genmab.comand the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO™ are trademarks of Janssen Pharmaceutica NV. TEPEZZA® is a trademark of Horizon Therapeutics plc.
1 Van de Berg YW et al. Blood 2012; 119:924.
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