Eli Lilly and China-based partner Innovent Biologics have released detailed trial results as they attempt to win front-line non-small cell lung cancer approval in China for their PD-1 checkpoint inhibitor, Tyvyt.
The ORIENT-11 trial is a randomized, double-blind, Phase 3 clinical trial of 397 patients that is assessing Tyvyt (sintilimab injection) with Lilly’s Alimta (pemetrexed) and platinum chemotherapy as a first-line treatment for nonsquamous non-small cell lung cancer (nsqNSCLC) without sensitive EGFR mutation or ALK rearrangement.I nterim analysis of the trial was announced at the virtual IASLC World Conference on Lung Cancer (WCLC) 2020.
Based on the analysis by an independent committee, the treatment demonstrated a statistically significant improvement in progression-free survival compared with placebo.
With a similar progression-free survival performance, the drug could challenge Merck's mega-blockbuster Keytruda in the non-small cell lung cancer field.
National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application for this indication.
Read the press release
