AstraZeneca’s Imfinzi Gets FDA Approval for Treating Endometrial Cancer

Pictured: Exterior of the FDA headquarters in Mary

Pictured: Exterior of the FDA headquarters in Mary

AstraZeneca on Monday secured FDA approval for its blockbuster Imfinzi, in combination with chemotherapy, to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.

Pictured: Exterior of the FDA headquarters in Maryland/iStock, Grandbrothers

AstraZeneca announced Monday that the FDA has approved its blockbuster cancer drug Imfinzi, in combination with chemotherapy, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.

The FDA’s approval of the PD-L1 blocker in endometrial cancer is based on the results of the DUO-E Phase III trial, which investigated the drug in combination with the chemotherapies carboplatin and paclitaxel followed by an Imfinzi monotherapy. The results, which were presented in October, showed that the Imfinzi combo reduced the risk of disease progression or death by 58% compared to those taking chemotherapy alone. The safety and tolerability of the Imfinzi-chemo combination were “generally manageable” and had no new safety issues.

“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,” Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca, said in a statement. “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.”

However, AstraZeneca isn’t stopping with just one combination in endometrial cancer. During the DUO-E trial, it also investigated Imfinzi in combination with its PARP inhibitor Lynparza, which reached the primary endpoint of progression-free survival (PFS) and reduced the risk of disease progression or death by 45%. Median PFS was also scored at 15.1 months in the Lynparza and Imfinzi arm versus 9.6 in the control group.

AstraZeneca said it continues to assess overall survival rates as a secondary endpoint in the Imfinzi-Lynparza combo and regulatory applications, which are under review in the European Union and Japan.

Imfinzi has also raked in several wins in other indications. In April, AstraZeneca announced that the PD-L1 blocker met its primary efficacy endpoints in a Phase III trial, demonstrating improvement in patients with limited-stage small cell lung cancer. While the exact numbers were not disclosed at the time, overall survival and PFS improvement was reported.

The drug has also been a significant earner for the U.K.-based pharma, bringing in over $1.1 billion in sales in the first quarter of 2024.

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
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