NMPA (China) approves Tyvyt + chemotherapy to treat first line metastatic gastric or gastroesophageal junction adenocarcinoma. - Innovent Biologics -+ Eli Lilly
Innovent Biologics, Inc. and Eli Lilly and Company announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for Tyvyt (sintilimab injection) in combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
The approval in China was based on the results of a randomized, double-blind, multicenter Phase III clinical trial (ORIENT-16, NCT03745170) evaluating sintilimab in combination with chemotherapy (oxaliplatin and capecitabine), compared to placebo in combination with chemotherapy, for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma. Based on the interim analysis by Independent Data Monitoring Committee (iDMC), sintilimab in combination with chemotherapy demonstrated superior overall survival (OS), compared to placebo plus chemotherapy, with a 34.0% reduction in the risk of death (HR 0.660?95%CI 0.505-0.864?p=0.0023) and a 5.5-month improvement in median OS (mOS 18.4 months vs. 12.9 months) in patients with combined positive score (CPS) ?5, and 23.4% reduction in the risk of death (HR 0.766, 95%CI 0.626-0.936?p=0.0090?and a 2.9-month improvement in mOS (15.2 months vs. 12.3 months) in all patients regardless of PD-L1 expression. The safety profile of sintilimab in this study was consistent with that observed in previously reported studies of sintilimab, and no additional safety signals were identified for the combination of sintilimab and chemotherapy. The results of ORIENT-16 study were presented at the European Society for Medical Oncology (ESMO) Congress 2021]..
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