Seattle Genetics, Astellas, and MSD Announce Global Phase III Collaboration to Evaluate Enfortumab Vedotin Plus Keytruda as First-Line Therapy for Locally Advanced or Metastatic Urothelial Cancer

On December 2, Seattle Genetics/Astellas announced a collaboration agreement with Merck Sharp & Dohme to jointly conduct clinical trials of the antibody-drug conjugate (ADC) enfortumab vedotin in combination with Keytruda for the first-line treatment of locally advanced or metastatic urothelial carcinoma.

Under the agreement, the three companies will fund and initiate a global registration-enabling Phase III study, which will be led by Seattle Genetics. The company is currently communicating with regulatory authorities regarding the trial design, with launch expected in the first half of 2020.

Enfortumab vedotin has submitted a marketing application to the FDA for locally advanced or metastatic urothelial carcinoma in patients who have received PD-1/L1 inhibitors and platinum-containing neoadjuvant/adjuvant chemotherapy. It is currently under FDA review, with a PDUFA date of March 15 next year.

Enfortumab vedotin utilizes Seattle Genetics’ proprietary linker technology to conjugate the microtubule-disrupting agent MMAE to an anti-Nectin-4 monoclonal antibody. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule expressed on various solid tumors.

Urothelial carcinoma is the most common type of bladder cancer, accounting for approximately 90% of cases. In 2019, there were more than 80,000 newly diagnosed cases of bladder cancer in the United States. Globally, there were an estimated 549,000 new cases of bladder cancer and approximately 200,000 deaths in 2018.