FDA Approves Durvalumab-Chemo Regimen for Advanced or Recurrent dMMR Endometrial Cancer

Durvalumab (Imfinzi) plus carboplatin and paclitaxel, followed by durvalumab monotherapy was approved by the FDA for patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

The regulatory decision was supported by data from the phase 3 DUO-E trial (NCT04269200), which showed that patients with dMMR tumors treated in the durvalumab arm (n = 95) experienced a median progression-free survival (PFS) that was not reached (NR; 95% CI, NR-NR) compared with 7 months (95% CI, 6.7-14.8) for patients in the placebo arm (HR, 0.42; 95% CI, 0.22-0.80).

In a news release, the FDA stated that although a statistically significant improvement in PFS was observed with the durvalumab regimen in the overall population, the improvement was attributed to patients with dMMR tumors, based on an exploratory analysis of MMR status.

The most common adverse effects reported in more than 25% of patients treated with durvalumab plus chemotherapy included peripheral neuropathy, musculoskeletal pain, nausea, alopecia, fatigue, abdominal pain, constipation, rash, diarrhea, vomiting, and cough.

The recommended dose of durvalumab is 1,120 mg with carboplatin plus paclitaxel every 3 weeks for 6 cycles, followed by single-agent durvalumab 1,500 mg every 4 weeks, in patients with a body weight of at least 30 kg. In patients with a body weight of less than 30 kg, durvalumab is recommended at 15 mg/kg in combination with carboplatin and paclitaxel every 3 weeks for 6 cycles, followed by 20 mg/kg of durvalumab every 4 weeks.