AstraZeneca: IMFINZI +chemo gets approval for endometrial cancer with dMMR

AstraZeneca’s IMFINZI or durvalumab in combination with carboplatin and paclitaxel followed by IMFINZI monotherapy has been approved in the US as treatment for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient or dMMR. The approval by the Food and Drug Administration, FDA was based on the results of a prespecified exploratory subgroup analysis by MMR status in the DUO-E Phase III trial. Results from DUO-E were published in the Journal of Clinical Oncology. …Shannon N. Westin, Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, and principal investigator of the trial, said, “With the incidence and mortality of endometrial cancer expected to continue to increase significantly in the coming decades, it is more important than ever that we bring new treatment options to patients at the earliest possible moment in their care. This approval underlines clear evidence that durvalumab plus chemotherapy followed by durvalumab monotherapy delivers important clinical benefits for patients with mismatch repair deficient endometrial cancer.”..The safety and tolerability profile of the IMFINZI and chemotherapy regimen was generally manageable, well tolerated and broadly consistent with prior clinical trials with no new safety signals…