Genmab A/S (GMAB -1.3%) and development partner Seattle Genetics (SGEN -1.7%) announce positive results from a Phase 2 clinical trial, innovaTV 204, evaluating antibody-drug conjugate (ADC) tisotumab vedotin in patients with recurrent/metatstatic cervical cancer who previously received doublet chemo and, if eligible, first-line bevacizumab [Roche’s (OTCQX:RHHBY -1.6%) Avastin]. The results were presented as ESMO.
The overall response rate (ORR) was 24% (n=24/100), including seven complete responders and 17 partials.
Based on median follow-up of 10 months, median duration of response (DOR) was 8.3 months. Median time to response was 1.4 months.
Median overall survival (OS) was 12.1 months and the six-month survival rate was 79%. Median progression-free survival (PFS) was 4.2 months while the PFS rate at month 6 was 30%.
On the safety front, the most common mild/moderate treatment-related adverse events were alopecia (hair loss) (38%), nose bleeds (epistaxis) (30%), nausea (27%), conjunctivitis (26%), fatigue (24%) and dry eye (23%).
The companies are co-developing the ADC under a 2017 agreement. It is composed of Genmab’s fully human monoclonal antibody specific for tissue factor and SGEN’s ADC linker technology.
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