GSK has announced that the China's National Medical Products Administration (NMPA) accepted a new drug application (NDA) for Nucala (mepolizumab) to be used as an add-on maintenance treatment for severe eosinophilic asthma (SEA). This marks the first targeted anti-interleukin-5 (IL-5) treatment for adult and adolescent patients with SEA in China if approved.
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The NDA is supported by positive data from a Phase III trial among Chinese patients and the global SEA development program that included - DREAM, MENSA, and SIRIUS. The trials have determined the efficacy and safety profile of Nucala for severe eosinophilic asthma patients. The Phase III trial in Chinese patients, which lasted for 52 weeks, evaluated the effect of Nucala as an add-on therapy in patients with SEA. The trial's primary endpoint was to reduce the annual rate of clinically significant exacerbations compared to a placebo. The study found that the efficacy in the Chinese population was consistent with the non-Chinese population with SEA.
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Nucala is currently approved in China for treating adults with eosinophilic granulomatosis with polyangiitis (EGPA). In January 2023, it was included in the National Reimbursement Drug List. However, it is not yet approved for treating SEA in China.
The National Medical Products Administration approved Enhertu (trastuzumab deruxtecan) for treating adult patients with unresectable or metastatic HER2-positive breast cancer previously treated with one or more anti-HER2-based regimens.
The approval was based on Phase 3 DESTINY-Breast03, progression-free survival was the primary endpoint, and overall survival was the secondary endpoint. The risk of disease progression or death was reduced by 72% versus trastuzumab emtansine. The median progression-free survival was not met in the Enhertu arm versus 6.8 months in patients on trastuzumab emtansine.
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The complete response was 16.1%, and a partial response was observed in 63.6%. Only 8.7% and 25.5% of patients who were on trastuzumab emtansine achieved complete response and partial responses.
Enhertu was an antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo. In 2022, China's NMPA granted Breakthrough Therapy Designation and Priority Review.
Tislelizumab is approved for advanced gastric or gastroesophageal junction adenocarcinoma with high PD-L1 expression in combination with chemotherapy. Chinas's National Medical Products Administration (NMPA) approved it with fluoropyrimidine and platinum chemotherapy.
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The approval was based on Phase 3, a placebo-controlled RATIONALE 305 trial evaluating tislelizumab in combination with chemotherapy. The trial included 997 participants worldwide, with overall survival being the primary endpoint. Progression-free survival was the secondary endpoint. Tislelizumab plus chemotherapy significantly improved overall survival, 17.2 months versus 12.6 months in patients on placebo.
Tislelizumab is yet to receive approval in the US and Europe; it is currently under review for advanced or metastatic esophageal squamous cell carcinoma.