FDA approves AstraZeneca's Imfinzi-chemo combo for advanced endometrial cancer in US

Published: 17-Jun-2024

Imfinzi reduced the risk of disease progression and death compared to chemotherapy alone by 58% in the recent Phase III DUO-E trial

AstraZeneca, a global pharmaceutical company, has received US FDA approval for the use of Imfinzi (durvalumab) in combination with carboplatin and paclitaxel to treat adults with primary advanced or recurrent endometrial cancer.

The combination therapy is designed to treat patients who are mismatch repair deficient (dMMR), and its approval has come off the back of the DUO-E Phase III trial — which was published in the Journal of Clinical Oncology.1

The results

In the trial, Imfinzi plus carboplatin and paclitaxel followed by Imfinzi monotherapy (Imfinzi arm) reduced the risk of disease progression or death by 58% in patients with dMMR endometrial cancer versus chemotherapy alone.2

Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, and principal investigator of the trial, Shannon N. Westin, said: “With the prevalence of endometrial cancer expected to increase, it’s 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.”


Safety and tolerability profile

The safety profile of the Imfinzi-chemotherapy combination was generally manageable and tolerated in the patient population; with the results aligning with prior clinical trials.1,2

The Lynparza (olaparib) and Imfinzi arm, which investigated Imfinzi plus chemotherapy followed by Imfinzi plus Lynparza as maintenance therapy, also met the primary endpoint of progression-free survival (PFS). 

The trial continues to assess OS as a key secondary endpoint for both arms. 

Regulatory applications for both Imfinzi as well as Imfinzi and Lynparza regimens are currently under review in the EU, Japan and several other countries based on the DUO-E results.



 Imfinzi (durvalumab) US prescribing information; Jun 2024.

2  Shannon N. Westin et al. Durvalumab Plus Carboplatin/Paclitaxel Followed by Maintenance Durvalumab With or Without Olaparib as First-Line Treatment for Advanced Endometrial Cancer: The Phase III DUO-E Trial. JCO 42, 283-299(2024).

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