The NMPA approval is based on the interim analysis of the Phase 3 ORIENT-15 clinical trial, in which sintilimab plus chemotherapy showed a statistically significant improvement in the primary endpoint of overall survival (OS)
Innovent Biologics and Lilly announced that the Chinese regulator approved their Tyvyt (sintilimab injection), in combination with chemotherapy, to treat a type of oesophageal cancer.
China’s National Medical Products Administration (NMPA) Centre for Drug Evaluation (CDE) approved the supplemental New Drug Application (sNDA) for Tyvyt plus chemotherapy.
The chemotherapy includes cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil.
Tyvyt plus chemotherapy is indicated for the treatment of unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma (ESCC).
It marks the fifth indication for Tyvyt in China, following classical Hodgkin’s lymphoma, non-squamous non-small cell lung cancer (NSCLC), squamous NSCLC and hepatocellular carcinoma.
Lilly China president and general manager Julio Gay-Ger said: “From Hodgkin’s lymphoma, lung cancer, liver cancer, and now to esophageal squamous cell carcinoma (ESCC), we are excited to see another indication of Tyvyt (sintilimab injection) approved in China in a short of time, bringing new options to Chinese esophageal cancer patients.
“With our commitment to oncology, Lilly strives to bring high-quality and affordable innovative drugs to Chinese cancer patients through both independent R&D and local partnerships. Tyvyt (sintilimab injection) sets a great example for our partnership with Innovent, and the new approval will further benefit more Chinese cancer patients.”
The NMPA approval is based on the interim analysis of ORIENT-15, a global randomised, double-blind, multi-centre Phase 3 clinical trial.
The Phase 3 study evaluated Tyvyt plus chemotherapy compared to placebo in combination with chemotherapy as first-line therapy for ESCC.
The interim analysis was conducted by an Independent Data Monitoring Committee (IDMC).
In the analysis, Tyvyt plus chemotherapy showed a statistically significant improvement in the primary endpoint of overall survival (OS) compared to placebo plus chemotherapy.
The drug combination showed consistent safety profile with that observed in previously reported studies of Tyvyt with new or unexpected safety signals, said Innovent.
ORIENT-15 Study principal investigator Shen Lin 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.
“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 and median PFS of 7.2 months 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.”
In August 2020, Lilly and Innovent expanded their licensing agreement for Tyvyt, to commercialise the drug outside of China.