FDA Approves Imfinzi Plus Chemo for dMMR Endometrial Cancer

The Food and Drug Administration (FDA) approved Imfinzi (durvalumab) plus carboplatin and paclitaxel, followed by single-agent Imfinzi for the treatment of adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

The approval was based off findings from the DUO-E clinical trial, where patients were randomly assigned to one of three groups:

• 1,120 mg of Imfinzi plus carboplatin/paclitaxel every three weeks for up to six cycles, followed by 1,500 mg of Imfinzi every four weeks as maintenance therapy until their disease progressed.
• Placebo (inactive drug) plus carboplatin and paclitaxel every three weeks for a maximum of six cycles, followed by a placebo as maintenance therapy every four weeks until disease progression.
• An additional investigational combination regimen.

The main goal of the trial was progression-free survival (PFS), which is the time patients live before their disease gets worse. Among 95 patients in the trial whose disease was dMMR – which occurs when there is a mutation that prevents cells from fixing errors when replicating DNA, according to the National Cancer Institute – the median PFS was not reached in the Imfinzi arm, meaning that not enough patients died or experienced disease progression for the researchers to calculate an average. Meanwhile, it was seven months in the placebo group.

Overall survival (time from treatment until death of any cause) data was not yet ready at the time of the most recent data collection.

The most common side effects that occurred in 25% or more of patients treated with Imfinzi included: peripheral neuropathy, musculoskeletal pain, nausea, hair loss, fatigue, abdominal pain, constipation, rash, diarrhea, vomiting and cough.

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