The approval represents the pharmaceutical company’s third perioperative approval in Europe for an Imfinzi-based regimen.
The European Commission has approved AstraZeneca’s Imfinzi (durvalumab) alongside chemotherapy as the first perioperative immunotherapy for early gastric and gastroesophageal cancers.
The regimen comprises the monoclonal antibody in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) in adults with Stages II, III, IVA, gastric and gastroesophageal junction (GEJ) cancers. This involves two cycles prior to and post surgery, then Imfinzi monotherapy.
The approval is based on positive data from the Matterhorn Phase III trial, published in the NEJM. Its authorisation follows the CHMP’s decision on the regimen in February.
Findings from the interim analysis found that the regimen reduced the risk of disease progression, recurrence or death by 29 percent, versus chemotherapy only.
Final overall survival analysis showed the regimen reduced the risk of death by 22 percent compared to chemotherapy alone. Additionally, an estimated 69 percent were alive at three years compared with 62 percent in the comparator arm.
This EU approval brings patients the first immunotherapy regimen to extend survival in this early setting and is poised to become the new standard of care”
Dr Josep Tabernero, the trial’s principal investigator, said: “Despite curative-intent surgery and chemotherapy, patients with resectable gastric and gastroesophageal cancers still face high recurrence rates and an urgent need for improved long-term survival.
“In Matterhorn, nearly 70 percent of patients were still alive three years after treatment with the durvalumab-based perioperative regimen. This EU approval brings patients the first immunotherapy regimen to extend survival in this early setting and is poised to become the new standard of care.”
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “This approval marks our third perioperative approval in Europe for an Imfinzi-based regimen, underscoring AstraZeneca’s commitment to transforming outcomes in early-stage disease, where cure is possible. For patients with early gastric and gastroesophageal cancers, this immunotherapy-based regimen delivers a durable survival benefit that increases over time.”
Overall survival results from Matterhorn were presented last year at the European Society for Medical Oncology (ESMO) Congress.
Imfinzi was first approved in May 2017. The biologic is authorised in combination with FLOT chemotherapy in the US and other countries based on the Matterhorn results.
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