Genmab Announces Preliminary Cervical Cancer Data from Tisotumab Vedotin Phase I/II Study
- Category: Antibodies
- Published on Saturday, 17 June 2017 08:42
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- Preliminary data shows responses achieved in 11 of 34 evaluable patients with cervical cancer treated with tisotumab vedotin
- Next steps in clinical development of tisotumab vedotin in this indication under active consideration
COPENHAGEN, Denmark I June 16, 2017 I Genmab A/S (Nasdaq Copenhagen: GEN) announced today preliminary data from the ongoing Phase I/II study of tisotumab vedotin in solid tumors (GEN701). In Part 2 of the study, 11 of 34 evaluable patients in the cervical cancer cohort achieved a response; with a median time of treatment of 4.9 months, 7 responders are still ongoing or in follow up for progression. The safety profile of tisotumab vedotin was consistent with known MMAE based antibody-drug conjugates (ADC), including peripheral neuropathy and neutropenia. Additionally, conjunctivitis was identified as a tisotumab vedotin specific toxicity, which led to introducing of prophylactic management. In the cervical cancer cohort, 15 patients experienced one or more Grade 3 adverse events: gastro-intestinal related (5 patients), anemia (2 patients), infections (1 patient), neuropathy (2 patients), bleeding (2 patients), other (10 patients). Genmab is considering plans for further clinical development of tisotumab vedotin in cervical cancer. The GEN701 study is ongoing and further data in both cervical cancer and other solid tumor indications will be published at a later date.
“The preliminary data we see in patients with cervical cancer treated with tisotumab vedotin are encouraging. We believe further development of this novel antibody-drug conjugate may be warranted in cervical cancer and are actively looking into possible next steps,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Genmab intends to submit data from this study for presentation at an upcoming medical conference.
About the GEN701 study
The GEN701 study is a 173 patient, two-part Phase I/II study of tisotumab vedotin in seven types of solid tumors: ovarian, cervical, endometrium, bladder, prostate, esophageal, and lung. Part 1 was a classical 3+3 dose escalation design testing various doses of tisotumab vedotin once every three weeks to establish the recommended Phase II (RP2D) and maximum tolerated dose as well as the safety profile of tisotumab vedotin. The still ongoing Part 2 of the study investigates all seven indications in parallel expansion cohorts. Patients receive 2.0 mg/kg (=RP2D) of tisotumab vedotin once every three weeks. The primary objective of this part of the study is to further investigate the safety profile of tisotumab vedotin and preliminary efficacy.
About tisotumab vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of a human antibody that binds to tissue factor (TF) conjugated to Seattle Genetics’ clinically validated cytotoxic drug MMAE. TF is a protein involved in tumor signaling and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, TF was selected as a target for an ADC approach. Tisotumab vedotin is in Phase I/II clinical development for solid tumors in two studies (GEN701 and GEN702). Genmab has a license and collaboration agreement for tisotumab vedotin with Seattle Genetics under which Seattle Genetics has the right to exercise a co-development option at the end of Phase I clinical development.
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 has two approved antibodies, DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications. Daratumumab is in clinical development for additional multiple myeloma indications, other blood cancers, and solid tumors. A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis. 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, and the HexaBody® platform which creates effector function enhanced antibodies. 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. For more information visit www.genmab.com.