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.



Copyright(c) 2024 RTTNews.com. All Rights Reserved

Copyright RTT News/dpa-AFX