FDA Rejects Lilly's Sintilimab/Chemo Combo Therapy In First-Line Lung Cancer Setting

The FDA sent a rejection letter to Eli Lilly And Co LLY regarding its anti-PD-1 antibody sintilimab for the first-line treatment of nonsquamous non-small cell lung cancer.

• The complete response letter (CRL) follows a nearly unanimous Oncologic Drugs Advisory Committee (ODAC) recommendation against sintilimab's approval. 
• 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.
• Read Next: Eli Lilly's Phase 3 Jardiance Study Stopped Early Due To Clear Positive Efficacy In Kidney Disease.
• As far as the next steps for sintilimab, which is approved in China, Lilly said it's assessing the situation with Innovent Biologics Inc IVBXF on the U.S. market.
• Price Action: LLY shares are up 0.84% at $286.57 during the market session on the last check Thursday.