Li Zhang, MD
The first-line combination of sintilimab injection (Tyvyt) plus pemetrexed (Alimta) and platinum-based therapy showed a statistically significant improvement in progression-free survival (PFS) compared with chemotherapy and placebo in patients with advanced or recurrent nonsquamous non–small cell lung cancer (NSCLC) who did not harbor EGFR
abnormalities, according to an interim analysis of the phase III ORIENT-11 trial (NCT03607539).1
In the Chinese study, results showed that the combination met the predefined efficacy criteria of the interim analysis, which was conducted by the Independent Data Monitoring Committee (IDMC). The safety profile of sintilimab injection was found to be consistent with prior studies, and no new safety signals were identified.
Further findings will be presented at an upcoming medical meeting. Based on a recommendation from the IDMC, Eli Lilly and Company and Innovent, the companies that are jointly developing sintilimab and pemetrexed, stated that they will initiate regulatory discussions with the National Medical Products Administration (NMPA) in China in the near future.
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