Policy & Regulation
Innovent Biologics and Eli Lilly's supplemental New Drug Application for TYVYT in combination with chemotherapy receives Chinese regulatory approval
21 June 2022 -

Innovent Biologics, Inc. (HKEX: 01801), a China-based biopharmaceutical company and US-based Eli Lilly and Company (NYSE: LLY) announced on Monday that they have received approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the supplemental New Drug Application (sNDA) for TYVYT (sintilimab injection) in combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil chemotherapy intended as the first-line treatment of unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

TYVYT received approval based on the interim analysis of ORIENT-15, a global randomised, double-blind, multi-centre Phase 3 clinical trial that assessed sintilimab in combination with chemotherapy compared to placebo in combination with chemotherapy as first-line therapy for ESCC. TYVYT in combination with chemotherapy showcased 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 based on the interim analysis carried out by the Independent Data Monitoring Committee (IDMC).

Prof Shen Lin, principal investigator of ORIENT-15 Study, Peking University Cancer Hospital and Institute, said, 'Esophageal cancer is one of the most common cancers in China ranking fifth in cancer prevalence and the fourth in mortality cases, with squamous cell carcinoma as most predominant histologic type. In the past, median OS was approximately 10 months for chemotherapy as the first-line standard of care. The results of ORIENT-15 demonstrated that sintilimab plus chemotherapy as the first-line treatment for ESCC significantly improved overall survival (OS) and progression-free survival (PFS) compared to placebo plus chemotherapy, with median OS of 16.7 months (vs. 12.5 months, HR=0.63) and median PFS of 7.2 months (vs. 5.7months, HR=0.56) for sintilimab plus chemotherapy. In addition, the results showed the general applicability of sintilimab with two different chemotherapy regimens. The approval of sintilimab in combination with chemotherapy as a first-line treatment for ESCC is exciting news and will provide an effective and affordable treatment option for patients living with ESCC in China.'

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