Eli Lilly expands Innovent alliance with $1 billion agreement

Aug. 18, 2020

Innovent Biologics and Eli Lilly have announced an expansion of their strategic alliance for TYVYT (sintilimab injection), an anti-PD-1 monoclonal antibody immuno-oncology medicine that was co-developed by Innovent and Lilly in China.

In 2019, Innovent and Lilly began commercializing the med in China after being granted marketing approval for relapsed or refractory classic Hodgkin's lymphoma after at least two lines of systemic chemotherapy. TYVYT is the only PD-1 inhibitor to be included in China's National Reimbursement Drug List (NRDL) and is included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies.

Innovent and Lilly currently co-commercialize TYVYT in China. Under the terms of the expanded license agreement, Lilly will obtain an exclusive license for TYVYT for geographies outside of China and plans to pursue registration of TYVYT in the U.S. and other markets. In return, Innovent will receive an upfront payment of $200 million and will be eligible for up to $825 million in potential development and commercial milestones, as well as tiered double-digit royalties on net sales. Both companies will also retain the right to study TYVYT in combination with other medicines as part of their own clinical programs.

Innovent is currently conducting more than 20 clinical studies with TYVYT to evaluate its safety and efficacy in a wide variety of cancer indications, including in combination with Lilly's Alimta (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer, and is actively pursuing the development of TYVYT outside of China. Earlier this month, the two companies released interim analysis data from ORIENT-11 at the IASLC World Conference on Lung Cancer 2020 Virtual Presidential Symposium. ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial evaluating TYVYT or placebo in combination with Alimta and platinum chemotherapy as a first-line treatment for advanced or recurrent non-squamous NSCLC without sensitizing EGFR mutations or ALK rearrangements. Based on the interim analysis conducted by the Independent Data Monitoring Committee, TYVYT in combination with Alimta and platinum chemotherapy demonstrated a statistically significant improvement in progression-free survival compared with placebo in combination with Alimta and platinum chemotherapy, which met the pre-defined efficacy criteria. A supplemental New Drug Application (sNDA) for this indication is under regulatory review in China.

Read the full Innovent statement