Tyvyt + Alimta + platinum met primary endpoint in phase III ORIENT-11 study as first-line therapy in nonsquamous NSCLC. Eli Lilly + Innovent Biologics

Eli Lilly and Company jointly announced with Innovent Biologics, Inc. the results of a Phase III study in China; the ORIENT-11 trial of Tyvyt (sintilimab injection) in combination with Alimta (pemetrexed) and platinum in first-line advanced or recurrent nonsquamous non-small cell lung cancer (nsqNSCLC), without sensitive EGFR mutation or ALK rearrangement, met the predefined primary endpoint of progression-free survival (PFS) in an interim analysis. Based on the interim analysis conducted by the Independent Data Monitoring Committee (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 (NMPA) in China in the near future. ORIENT-11 is a randomized, double-blind, Phase III clinical trial to evaluate the efficacy and safety of Tyvyt (sintilimab injection) or placebo in combination with Alimta and platinum as first-line therapy for advanced or recurrent nsqNSCLC without sensitive EGFR mutation or ALK rearrangement (ClinicalTrials.gov, NCT03607539). The primary endpoint is progression-free survival (PFS) assessed by the Independent Radiographic Review Committee (IRRC) based on RECIST v1.1. The other secondary endpoints include overall survival (OS) and safety profile. A total of 397 subjects have been enrolled in the ORIENT-11 trial and randomized in a 2:1 ratio to receive either sintilimab 200mg or placebo in combination with Alimta and platinum every three weeks for up to four cycles, followed by either sintilimab or placebo plus Alimta maintenance therapy. The subjects will receive treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation. Conditional crossover is permitted.