Therapy Areas: Oncology
Seattle Genetics, Genmab Present Data from Tisotumab Vedotin innovaTV 204 Pivotal Trial in Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2020
21 September 2020 - - US-based biotechnology company Seattle Genetics, Inc. (NASDAQ: SGEN) and Denmark-based biotechnology company Genmab A/S (NASDAQ: GMAB) have presented data from the innovaTV 204 pivotal phase 2, single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent and/or metastatic cervical cancer at the European Society for Medical Oncology Virtual Congress 2020, the companies said.

Patients had previously received a doublet chemotherapy and, if eligible, bevacizumab as first-line therapy. Results from the trial showed a 24% confirmed objective response rate by independent central review with a median duration of response of 8.3 months.

The most common treatment-related adverse events (greater than or equal to 20 %) included alopecia, epistaxis (nose bleeds), nausea, conjunctivitis, fatigue and dry eye.

Tisotumab vedotin is an investigational antibody-drug conjugate directed to tissue factor, which is prevalent on solid tumors including cervical cancer and can promote tumor growth, angiogenesis and metastasis.

Current therapies for previously treated recurrent and/or metastatic cervical cancer generally result in limited objective response rates of typically less than 15% with median overall survival ranging from 6.0 to 9.4 months.

Data presented at ESMO include the primary endpoint of confirmed ORR as assessed by independent central review in 101 patients treated with tisotumab vedotin in the trial.

Secondary endpoints included DOR, time to response, progression-free survival, overall survival, safety and tolerability.

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.

Additionally, patients were eligible if they had received up to two prior lines of therapy in the recurrent and/or metastatic setting. In the study, 101 patients were treated with tisotumab vedotin at multiple centers in the US and Europe.

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, progression-free survival, overall survival, safety and tolerability.

The study was conducted in collaboration with European Network of Gynaecological Oncological Trial Groups (ENGOT) and Gynecologic Oncology Group.

Tisotumab vedotin is an investigational antibody-drug conjugate 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 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.

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 monotherapy in a range of solid tumors, including recurrent and/or metastatic cervical cancer, ovarian cancer, and other solid tumors and in combination with commonly used therapies in recurrent or metastatic cervical cancer.

These trials are evaluating tisotumab vedotin on a weekly or every three-week dosing schedule.
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