China-based Innovent Biologics Inc., (HKG: 1801) has announced that the National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for Tyvyt (sintilimab injection) in combination with bevacizumab and chemotherapy (pemetrexed and cisplatin) for patients with epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) who have progressed after EGFR tyrosine kinase inhibitor (TKI) therapy. This milestone makes Tyvyt the first PD-1 inhibitor globally approved for this specific patient population, marking a significant breakthrough in the field of immunotherapy.
Seventh Indication for Tyvyt Covered by NRDL
This new approval represents the seventh indication for Tyvyt, with the first six indications already covered by the National Reimbursement Drug List (NRDL) in China. The expansion of indications underscores the drug’s growing importance in the treatment of various lung cancer conditions.
Phase III Clinical Trial Results Lead to Approval
The approval in China is based on the positive results from the randomized, double-blind, multi-center, prospective Phase III clinical trial (ORIENT-31, NCT03802240), which evaluated Tyvyt in combination with Byvsada (bevacizumab injection) and chemotherapy (pemetrexed and cisplatin). The second interim analysis, as of March 31st, 2022, showed that the sintilimab regimen demonstrated significant and clinically meaningful progression-free survival (PFS) benefits compared to chemotherapy alone in the intent-to-treat (ITT) population (median PFS: 7.2 months vs. 4.3 months; HR=0.51, p<0.0001). Additionally, the study observed improvements in objective response rate (ORR) and duration of response (DOR). The safety profile of the study was consistent with previous reports on sintilimab and bevacizumab.-Fineline Info & Tech
