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FDA Approves AstraZeneca's Imfinzi, Chemotherapy for MMR-Deficient Endometrial Cancer

NEW YORK – The US Food and Drug Administration on Friday approved AstraZeneca's immune checkpoint inhibitor Imfinzi (durvalumab) plus chemotherapy in DNA mismatch repair (MMR) deficient endometrial cancer. 

The agency approved a regimen of the PD-1 checkpoint inhibitor combined with carboplatin and paclitaxel chemotherapy followed by single-agent Imfinzi. 

The approval is based on the results of the Phase III DUO-E clinical trial, which included 805 patients with advanced or recurrent endometrial cancer. Patients weren't required to have mismatch repair deficient tumors to be eligible for the trial, but they did need to have available tissue for MMR immunohistochemistry testing. 

Although adding Imfinzi to chemotherapy versus placebo and chemo benefited allcomers, the researchers deduced that patients with dMMR tumors were driving the observed progression-free survival benefit. 

Among dMMR patients who received Imfinzi plus chemotherapy followed by Imfinzi, the median progression-free survival was not yet reached. Among dMMR patients who received chemotherapy and placebo, meanwhile, the median progression-free survival was seven months. 

Imfinzi is also FDA-approved in certain patients with advanced non-small cell lung cancer, small cell lung cancer, biliary tract cancer, and liver cancer. This newest dMMR endometrial cancer approval, however, is the drug's first biomarker-specific indication.