- Eli Lilly (NYSE:LLY) and Innovent Biologics (OTCPK:IVBIY) announce that the results of Phase 3 ORIENT-3 study evaluating Tyvyt (sintilimab injection) vs. docetaxel as a second-line treatment for advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) were released at AACR Meeting 2021.
- A total of 290 patients were enrolled. Tyvyt demonstrated a statistically significant improvement in overall survival (OS) compared to docetaxel, meeting the pre-specified primary endpoint.
- The median OS was 11.79 months for patients on Tyvyt arm and 8.25 months for those on docetaxel (HR=0.74, 95% CI: 0.56-0.96, P=0.02489).
- The median progression-free survival (PFS) was 4.30 months vs. 2.79 months (HR=0.52, 95% CI: 0.39-0.68, P<0.00001), and the confirmed objective response rate (ORR) was 25.5% vs. 2.2% (P<0.00001), respectively.
- Safety was consistent with previous studies of Tyvyt and no new safety signals were identified.