AstraZeneca Imfinzi regimen for endometrial cancer gains FDA approval
AstraZeneca‘s Imfinzi (durvalumab), in combination with chemotherapy, has received approval from the US Food and Drug Administration (FDA) for treating adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).
The treatment regimen comprises Imfinzi plus chemotherapy including carboplatin and paclitaxel, followed by Imfinzi monotherapy. This approval from the FDA is based on a subgroup analysis from the DUO-E Phase III trial, which focused on MMR status.
The randomised, multicentre, double-blind, placebo-controlled study assessed Imfinzi plus platinum-based chemotherapy followed by either Imfinzi monotherapy or Imfinzi plus Lynparza (olaparib), against chemotherapy alone. It included 699 patients with newly diagnosed advanced or recurrent epithelial endometrial carcinoma.
Results showed that the Imfinzi combination regimen reduced the risk of disease progression or death by 58% in patients versus chemotherapy alone. Imfinzi and chemotherapy regimen’s safety profile was found to be generally manageable and well-tolerated, aligning with outcomes from previous trials without any new safety concerns.
The Lynparza and Imfinzi arm also met the trial’s primary endpoint of progression-free survival (PFS). Regulatory submissions for the Imfinzi and Lynparza regimens are currently under review in regions and countries including the European Union and Japan, drawing from the data from the DUO-E trial.
The latest development comes after the FDA approved AstraZeneca‘s Farxiga (dapagliflozin) for the treatment of paediatric patients aged 10 years and above with type-2 diabetes.
June 19, 2024
