FDA Approves IMFINZI® Plus Chemotherapy for Mismatch Repair Deficient Advanced or Recurrent Endometrial Cancer

AstraZeneca‘s IMFINZI® (durvalumab) in combination with carboplatin and paclitaxel followed by IMFINZI monotherapy has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

The approval was based on the results of a prespecified exploratory subgroup analysis by MMR status in the DUO-E Phase III trial, published in the Journal of Clinical Oncology. The trial demonstrated that the IMFINZI arm reduced the risk of disease progression or death by 58% in patients with dMMR endometrial cancer compared to chemotherapy alone.

Endometrial cancer is the fourth most common cancer among women in the United States, with over 66,000 patients diagnosed and nearly 12,000 deaths in 2022. While early-stage endometrial cancer has a five-year survival rate of 80-90%, advanced disease survival rates drop below 20%, highlighting the urgent need for new treatment options.

“The approval of IMFINZI offers an important new option for patients with mismatch repair deficient endometrial cancer,” said Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca. “Immunotherapy in combination with chemotherapy is emerging as a new standard of care in this setting, and we are committed to continued innovation as the burden of this cancer is expected to grow in the future.”

Professor Shannon N. Westin, principal investigator of the trial and Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, emphasized the significance of bringing new treatment options to patients as early as possible in their care, given the expected increase in endometrial cancer incidence and mortality in the coming decades.

The safety and tolerability profile of the IMFINZI and chemotherapy regimen was generally manageable and well tolerated, with no new safety signals reported.

AstraZeneca also investigated the combination of LYNPARZA® (olaparib) and IMFINZI in the DUO-E trial, which met the primary endpoint of progression-free survival. The trial continues to assess overall survival as a key secondary endpoint for both arms. Regulatory applications for both IMFINZI and IMFINZI plus LYNPARZA regimens are currently under review in the EU, Japan, and several other countries based on the DUO-E results.

  • FDA approves AstraZeneca’s IMFINZI® (durvalumab) plus chemotherapy for advanced or recurrent endometrial cancer with mismatch repair deficiency (dMMR)
  • DUO-E Phase III trial showed a 58% reduction in the risk of disease progression or death compared to chemotherapy alone
  • Endometrial cancer incidence and mortality expected to rise, highlighting the need for new treatment options
  • Approval offers a crucial new therapy for patients facing poor outcomes with advanced disease
AstraZeneca scientist working in a lab.

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