Innovent Biologics : China Accepts SNDA Of TYVYT On Lung-cancer

(RTTNews) - Innovent Biologics Inc. said that the National Medical Products Administration or NMPA of China has accepted the supplemental New Drug Application (sNDA) for sintilimab plus bevacizumab biosimilar injection and chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung-cancer (nsqNSCLC) who progressed after EGFR-TKI therapy.

The application was based on the first interim analysis of ORIENT-31, the randomized, double-blind, multi-center Phase 3 clinical trial - which evaluated sintilimab in combination with or without bevacizumab biosimilar and chemotherapy compared to placebo in combination with chemotherapy for patients with EGFR-mutated nsqNSCLC who had disease progression after EGFR-TKI therapy.

According to the first interim analysis conducted by the Independent Data Monitoring Committee, Arm A (sintilimab in combination with bevacizumab and chemotherapy) demonstrated a statistically significant improvement in the primary endpoint of IRRC-assessed progression-free survival compared to Arm C (placebo in combination with chemotherapy).

In addition, key secondary endpoints of objective response rate (ORR) and duration of response (DOR) were improved in Arm A compared with Arm C, which was immature yet.

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company.