AstraZeneca PLC (AZN) on Monday said that its cancer immunotherapy Imfinzi, in combination with standard-of-care FLOT chemotherapy, has been recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) in the European Union for the treatment of adults with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers.
The proposed regimen includes neoadjuvant Imfinzi with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) before surgery, followed by adjuvant Imfinzi with chemotherapy, and then Imfinzi monotherapy.
The CHMP's positive opinion was based on results from the MATTERHORN Phase III trial which showed a 29% reduction in the risk of progression, recurrence or death and a 22% reduction in the risk of death for the Imfinzi regimen versus chemotherapy alone.
Imfinzi is already approved in the United States and other countries for the same indication based on the MATTERHORN results. Regulatory reviews are currently underway in Japan and several other markets.
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