China-based Innovent Biologics, Inc. (HKG: 1801) and its partner Eli Lilly & Co. (NYSE: LLY) announced that the PD-1 inhibitor Tyvyt (sintilimab) has been approved by the National Medical Products Administration (NMPA) for a new indication. The drug is now approved to treat first-line unresectable locally advanced, recurrent, or metastatic gastric and gastroesophageal junction adenocarcinoma (GC/GEJC) in combination with fluorouracil and platinum-based chemotherapy.
Approval Based on ORIENT-16 Study
The approval is based on the results of the randomized, double-blind, multi-center Phase III ORIENT-16 study. An interim analysis conducted by the Independent Data Monitoring Committee (iDMC) showed that the combination therapy significantly reduced the risk of death in the PD-L1 CPS ≥5 population (HR 0.660, 95%CI 0.505-0.864, p=0.0023) and overall population (HR 0.766, 95%CI 0.626-0.936, p=0.0090), meeting the pre-set superiority criteria. The median overall survival (mOS) was extended by 5.5 months in the CPS≥5 population (mOS 18.4 months vs. 12.9 months) and 2.9 months in the overall population (mOS 15.2 months vs. 12.3 months). The safety profile is consistent with previously reported clinical studies, with no new safety signals. The results were published at the 2021 European Society for Medical Oncology (ESMO) annual meeting. The ORIENT-16 study is the first randomized, double-blind Phase III clinical study led by Chinese researchers to demonstrate significant benefits of immunotherapies combined with chemotherapy in the first-line treatment of advanced gastric cancer in the whole population.
Tyvyt’s Previous Approvals and Future Outlook
First approved in China in December 2018, Tyvyt has been approved for five indications, including third-line treatment for relapsed or refractory classic Hodgkin’s lymphoma (cHL); first-line treatment for non-squamous non-small cell lung cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy; first-line treatment for squamous NSCLC in combination with gemcitabine and platinum chemotherapy; first-line treatment for hepatocellular carcinoma in combination with Byvasda (bevacizumab biosimilar injection); and first-line treatment of esophageal squamous cell carcinoma (ESCC). With this new approval, Innovent and Eli Lilly continue to expand Tyvyt’s therapeutic applications, addressing significant unmet needs in oncology.-Fineline Info & Tech
