LONDON (dpa-AFX) - AstraZeneca PLC (AZN.L) Monday said its Imfinzi plus chemotherapy was approved by the Food and Drug Administration (FDA) to treat patients with mismatch repair deficient (dMMR) endometrial cancer.
The approval was based on results from the DUO-E Phase 3 trial, in which Imfinzi plus chemotherapy followed by Imfinzi monotherapy reduced the risk of disease progression or death by 58 percent in patients with dMMR endometrial cancer versus chemotherapy alone.
The DUO-E trial is a three-arm Phase III trial of 1st-line Imfinzi plus platinum-based chemotherapy followed by either Imfinzi monotherapy or Imfinzi plus Lynparza as maintenance therapy versus platinum-based chemotherapy alone as a treatment for patients with newly diagnosed advanced or recurrent endometrial cancer.
The Lynparza and Imfinzi arm, which investigated Imfinzi plus chemotherapy followed by Imfinzi plus Lynparza as maintenance therapy, also met the primary endpoint of progression-free survival.
Regulatory applications for both Imfinzi as well as Imfinzi and Lynparza regimens are currently under review in the EU, Japan and several other countries.
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