March 24 Quick Takes: Lilly, Innovent weigh next steps after setback at FDA for PD-1 therapy

As expected based on FDA’s statements and the outcome of a meeting of the Oncologic Drugs Advisory Committee (ODAC), FDA has issued a complete response letter for Tyvyt sintilimab from Innovent Biologics Inc. (HKEX:1801) and Eli Lilly and Co. (NYSE:LLY). FDA and its advisers said that the failure to enroll patients outside of China, as well as the use of a placebo-controlled trial design, were unacceptable. “The CRL includes a recommendation for an additional clinical study, specifically a multiregional clinical trial comparing standard of care therapy for first line metastatic NSCLC to sintilimab with chemotherapy utilizing a non-inferiority design with an overall survival endpoint,” Lilly stated. Lilly said that together with Innovent, it is “assessing next steps for the sintilimab program in the U.S.” Further development of the drug for marketing in the U.S. is unlikely. At the ODAC meeting, Lilly said it would take seven years to complete a trial similar to the one FDA has requested.

Imfinzi durvalumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) missed the primary progression-free survival (PFS) endpoint in the Phase III CALLA to treat locally advanced cervical cancer, an indication where market-leading PD-1 inhibitors Keytruda pembrolizumab and Opdivo nivolumab have not been approved. Imfinzi plus chemoradiotherapy failed to significantly increase PFS over chemoradiotherapy alone in the first-line setting. Keytruda is approved to treat PD-L1-expressing recurrent or metastatic cervical cancer with disease progression on or after chemotherapy...