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.
Innovent’s Tyvyt was approved by NMPA for 2L+ R/R Hodgkin lymphoma in December 2018. It is being co-developed by Lilly under a 2015 agreement where Innovent develops three oncology programs , and Lilly takes the lead in commercialization. Innovent has co-promotion rights, and will co-market in China, Hong Kong, and Macau.
In April 2019, Keytruda/chemotherapy was approved for 1L metastatic nonsquamous NSCLC without EGFR mutations or ALK aberrations, and now faces impending competition from Tyvyt. Competing with Keytruda in China is likely to pose a strong obstacle to Innovent/Lilly, as Keytruda has racked up three total NMPA approvals for 1L NSCLC in the past year. According to Innovent’s press release, 70% of NSCLC cases are nonsquamous and 50% of those are without EGFR mutations or ALK rearrangements
Overall, the Chinese PD-1 axis inhibitor market continues to heat up. Most recently, in December 2019, BeiGene’s tislelizumab was approved for R/R cHL. Three additional antibodies from Chinese companies are also approved, along with Opdivo (nivolumab; NSCLC), Imfinzi (durvalumab; NSCLC) and Keytruda (pembrolizumab; melanoma, NSCLC). Jiangsu Hengrui’s camrelizumab was approved in May 2019 for cHL, joining Junshi’s Tuoyi (toripalimab; melanoma) and Innovent/Lilly’s Tyvyt (sintilimab; cHL).
Source: Innovent Press Release