Trial to evaluate enfortumab vedotin & Keytruda in metastatic urothelial cancer

Seattle Genetics and Astellas Pharma have together entered into a clinical collaboration with Merck to evaluate the duo’s antibody-drug conjugate (ADC) enfortumab vedotin and Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab) in patients with previously untreated metastatic urothelial cancer.

The three companies will conduct and fund a global, registrational phase 3 clinical trial to be led by Seattle Genetics. The trial will be designed to evaluate the efficacy of the combination of enfortumab vedotin and pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer.

The companies are working in consultation with regulatory authorities to finalise the trial design and currently plan to initiate the trial in the first half of 2020.

“Recent data from a phase 1b trial of enfortumab vedotin in combination with pembrolizumab showed evidence of clinical activity leading to the development of this phase 3 trial,” said Roger Dansey, Chief Medical Officer at Seattle Genetics.

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