NEW YORK – China's National Medical Products Administration (NMPA) on Tuesday approved Innovent Biologics' Tyvyt (sintilimab) in combination with bevacizumab and chemotherapy for EGFR-mutated non-small cell lung cancer patients who progressed after EGFR tyrosine kinase inhibitor (TKI) therapy.
The approval was based on results from the Phase III ORIENT-31 clinical trial, which compared the Tyvyt-bevacizumab-chemotherapy combination to placebo plus chemotherapy. In a second interim analysis from that trial, the three-drug combination demonstrated a median progression-free survival of 7.2 months versus 4.3 months on chemo plus placebo. The Tyvyt arm also demonstrated improved response rates and duration of response compared to chemo alone. The median overall survival in the Tyvyt arm was 21.1 months compared to 19.2 months in the chemo arm.
This NMPA approval marks the first PD-1 inhibitor to be approved for patients with EGFR-mutant NSCLC who have received prior EGFR inhibitor therapy, according to Innovent. In China, Tyvyt is also approved for non-squamous NSCLC, squamous NSCLC, hepatocellular carcinoma, esophageal squamous cell carcinoma, gastric cancer, and classic Hodgkin's lymphoma.
"Different from the Western population, about half of the Chinese patients with NSCLC have EGFR mutations," Shun Lu, principal investigator of the ORIENT-31 study and professor in the oncology department of Shanghai Chest Hospital, said in a statement. "EGFR-TKI targeted therapy is the first-line treatment choice in NSCLC patients with EGFR-sensitive mutation. However, almost all patients will eventually develop TKI resistance and progression of disease, and there are no good treatment options for EGFR-TKI failed NSCLC population."