The US Food and Drug Administration (FDA) has approved AstraZeneca’s Imfinzi (durvalumab) in combination with carboplatin and paclitaxel chemotherapy, followed by durvalumab monotherapy, to treat certain types of endometrial cancer.

The approval is for the treatment of adult patients having primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). It was based on the findings from a prespecified exploratory subgroup analysis by MMR status in the DUO-E Phase 3 trial.

DUO-E is a three-arm, randomised, double-blind, placebo-controlled, multicentre trial of 699 patients with newly diagnosed advanced or recurrent endometrial cancer.

The late-stage study’s dual primary endpoint was progression-free survival (PFS) of each treatment arm compared to standard of care. Additionally, key secondary endpoints comprised overall survival (OS), as well as safety and tolerability assessments.

In the trial, treatment with Imfinzi in combination with carboplatin and paclitaxel, followed by Imfinzi monotherapy, resulted in a 58% reduction in the risk of disease progression or death compared to chemotherapy alone.

The safety and tolerability profile of the Imfinzi and chemotherapy regimen was generally manageable and well tolerated.

It was consistent with prior clinical trials, showing no new safety signals.

AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “There have been limited advances in the treatment of endometrial cancer in the last few decades, and continued innovation is critical as the burden of this cancer is expected to grow in the future.

“Immunotherapy in combination with chemotherapy is emerging as a new standard of care in this setting, and the approval of Imfinzi offers an important new option for patients with mismatch repair deficient disease.”

The Lynparza (olaparib) and Imfinzi arm, which studied the Imfinzi-chemo combination followed by Imfinzi plus Lynparza as maintenance therapy, also achieved the primary endpoint of PFS.

The trial is ongoing to evaluate OS as a key secondary endpoint for both treatment arms.

Regulatory submissions for both the Imfinzi monotherapy and the Imfinzi plus Lynparza regimens are currently under review in the European Union, Japan, and several other countries based on the results from the DUO-E trial.

The monoclonal antibody is already approved for unresectable, Stage 3 non-small cell lung cancer (NSCLC) and ES-SCLC, metastatic NSCLC, and unresectable hepatocellular carcinoma (HCC).