Policy & Regulation
Genmab and Seattle Genetics to present data on tisotumab vedotin at ESMO 2018 Congress in Munich, Germany
10 October 2018 -

Genmab A/S (CPH:GEN), a biotechnology company specialising in the creation and development of differentiated antibody therapeutics for the treatment of cancer, and Seattle Genetics Inc (Nasdaq: SGEN), an emerging multi-product, biotechnology company that develops and commercialises transformative therapies targeting cancer, announced on Tuesday that updated clinical data from the innovaTV 201 phase II study evaluating tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer will be presented as a poster at the European Society for Medical Oncology (ESMO) 2018 Congress taking place in Munich, Germany from 19 October 2018 to 23 October 2018.

Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) designed to target the Tissue Factor (TF) antigen, which is expressed on a broad range of solid tumours.

This poster, entitled 'A phase IIa study of tisotumab vedotin in patients with previously treated recurrent or metastatic cervical cancer: updated analysis of full cervical expansion cohort', will be presented by Nicole Concin, M.D. Medical University of Innsbruck, Austria on 20 October 2018, 12:30 hours to 13:30 hours CEST.

Reportedly, the innovaTV 201 study is a 170 patient, two-part phase I/II study of tisotumab vedotin in eight types of solid tumours, namely ovarian, cervical, endometrial, bladder, prostate, oesophageal, lung, and head and neck. Part 1 is 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. Part 2 of the study investigates all eight indications in parallel expansion cohorts. The cervical cancer cohort includes 55 patients. 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.

Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab's human antibody that binds to Tissue Factor (TF) and Seattle Genetics' ADC technology that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E (MMAE). TF is a protein involved in tumour cell signalling and angiogenesis. Based on its high expression on many solid tumours and its rapid internalization, TF was selected as a target for an ADC approach.

Currently, tisotumab vedotin is being evaluated in ongoing or planned phase II trials in recurrent and/or metastatic cervical cancer, ovarian cancer and other solid tumours. Tisotumab vedotin is being co-developed by Genmab and Seattle Genetics.

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