The regulatory agency has issued a complete response letter (CRL) to the Biologics License Application (BLA) for sintilimab, which is being co-developed by Innovent Biologics.
It recommended the companies to run an additional clinical trial of sintilimab against the standard of care therapy for first line metastatic NSCLC.
An investigational PD-1 inhibitor, sintilimab is an immunoglobulin G4 monoclonal antibody type.
It works by binding to PD-1 molecules on the T-cells surface, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells for killing the cancer cells.
Eli Lilly is evaluating further steps for the sintilimab programme along with Innovent in the US.
At present, Innovent is conducting over 20 clinical studies to assess sintilimab’s efficacy and safety in a range of cancer indications that include more than 10 registrational or pivotal clinical trials.
The PD-1 inhibitor, which is marketed as TYVYT (sintilimab injection), has been approved in China to treat relapsed or refractory classic Hodgkin’s lymphoma following two lines or later of systemic chemotherapy.
It also received approval for the first-line NSCLC treatment in combination with pemetrexed and platinum chemotherapy.
Furthermore, sintilimab has been granted approval for the first-line treatment of squamous non-small cell lung cancer along with gemcitabine and platinum chemotherapy.
Recently, Eli Lilly and Erasca entered into a clinical trial partnership and supply deal for assessing an oral ERK1/2 inhibitor, ERAS, in combination with Eli Lilly’s anti-EGFR antibody cetuximab (ERBITUX).