NMPA (China) approves the sNDA for Tyvyt + cisplatin + paclitaxel or cisplatin + 5-fluorouracil chemotherapy for the first-line metastatic esophageal squamous cell carcinoma.
Innovent Biologics and Eli Lilly announced that the Center for Drug Evaluation of China's National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for Tyvyt (sintilimab injection) in combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
The new approval was based on the interim analysis of ORIENT-15, a global randomized, double-blind, multi-center Phase III clinical trial – which evaluated sintilimab in combination with chemotherapy compared to placebo in combination with chemotherapy as first-line therapy for ESCC. 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 regardless of PD-L1 expression status, meeting the pre-defined superior efficacy criteria. Safety profile was consistent with that observed in previously reported studies of sintilimab without new or unexpected safety signals. The results of ORIENT-15 were published in British Medical Journal on April 19, 2022.
See-"Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase III trial ".Zhihao Lu, Junye Wang, Yongqian Shu, Lianke Liu, Li Kong, Lei Yang. et al., -BMJ 2022; 377: e068714 (Published 19 Apr 2022).
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