Phase III ORIENT-11 trial of Tyvyt plus Alimta shows efficacy in NSCLC.- Innovent Biologics + Eli Lilly

Innovent Biologics announced with Eli Lilly that interim analysis data from the phase III ORIENT-11 trial of Tyvyt (sintilimab injection) in combination with Alimta (pemetrexed) and platinum chemotherapy as a first-line treatment in people with nonsquamous non-small cell lung cancer (nsqNSCLC) were released at the IASLC World Conference on Lung Cancer (WCLC) 2020 Virtual Presidential Symposium. On the same day, the data was published online by the Journal of Thoracic Oncology. This trial was conducted to assess the efficacy of sintilimab injection in combination with pemetrexed and platinum chemotherapy as a first-line treatment in people with nsqNSCLC without sensitive EGFR mutation or ALK rearrangement. ORIENT-11 is a randomized, double-blind, Phase III clinical trial evaluating Tyvyt (sintilimab injection) or placebo in combination with Alimta (pemetrexed) and platinum chemotherapy as a first-line treatment for advanced or recurrent nsqNSCLC without sensitizing EGFR mutations or ALK rearrangements. Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), Tyvyt (sintilimab injection) in combination with Alimta (pemetrexed) and platinum chemotherapy demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo in combination with Alimta (pemetrexed) and platinum chemotherapy, which met the pre-defined efficacy criteria. After a median follow up of 8.9 months, the median PFS of the sintilimab combination and the placebo combination assessed by the Independent Radiographic Review Committee (IRRC) was 8.9 months and 5.0 months, respectively [HR (95%CI) = 0.482 (0.362, 0.643), P < 0.00001]. The median overall survival (OS) was not reached in both groups, but OS showed an improvement favoring the sintilimab combination (HR=0.609, 95%CI: 0.400-0.926). Confirmed objective response rate (assessed by IRRC) was improved from 29.8% to 51.9%, and the sintilimab combination showed a shorter time to response (median time to response: 1.51 months in the sintilimab combination versus 2.63 months in the placebo combination). The safety profile was consistent with previously reported sintilimab studies, and no new safety signals were identified. National Medical Products Administration of China has accepted the supplemental New Drug Application for this indication.