February 7, 2020
- Innovent Biologics and Eli Lilly have announced that the phase 3 ORIENT-11 trial (NCT03607539) in China has met its primary endpoint of progression-free survival (PFS) for the use of Tyvyt (sintilimab) in combination with ALTIMA (pemetrexed) and platinum-based chemotherapy for patients with 1L advanced or recurrent nonsquamous NSCLC without EGFR mutations or ALK rearrangements tumors, when compared to placebo.
- The safety profile of Tyvyt was consistent with previous studies, and no new safety signals emerged.
- Based on this data, Innovent and Eli Lilly plan to initiate regulatory discussions with China’s National Medical Products Administration (NMPA) in the near future.
- Data will be presented at an upcoming medical conference.