Innovent Announces NMPA Acceptance of a Supplemental New Drug Application for Sintilimab in Combination with Chemotherapy as First-Line Treatment for Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Excerpt from the Press Release:

SAN FRANCISCO and SUZHOU, China, Nov. 4, 2021 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for sintilimab in combination with chemotherapy (oxaliplatin and capecitabine) for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

The sNDA application is based on the interim analysis of the randomized, double-blind, multi-center Phase 3 ORIENT-16 clinical trial – which evaluated 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 (G/GEJ) adenocarcinoma. Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), sintilimab in combination with chemotherapy demonstrated a statistically significant improvement in the primary endpoint of overall survival (OS) compared to placebo in combination with chemotherapy, in both the intention-to-treat (ITT) group and PD-L1 positive group. The results of ORIENT-16 study were released in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2021.

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