Eli Lilly announces ORIENT-11 trial met primary endpoint in interim analysis
Eli Lilly jointly announced with Innovent Biologics, the results of a Phase 3 study in China; the ORIENT-11 trial of Tyvyt in combination with Alimta and platinum in first-line advanced or recurrent nonsquamous non-small cell lung cancer, or nsqNSCLC, without sensitive EGFR mutation or ALK rearrangement, met the predefined primary endpoint of progression-free survival, or PFS, in an interim analysis. Based on the interim analysis conducted by the Independent Data Monitoring Committee, or IDMC, sintilimab in combination with Alimta and platinum demonstrated a statistically significant improvement in PFS compared with placebo in combination with Alimta and platinum, which met the pre-defined efficacy criteria. The safety profile of sintilimab in this trial was consistent with previously reported studies, and no new safety signals were identified. Relevant data will be presented at an upcoming medical conference. Based on the IDMC recommendations, Lilly and Innovent will initiate regulatory discussions for registration with the National Medical Products Administration, or NMPA, in China in the near future.