FDA nod for Keytruda sets up three-way battle in endometrial cancer

18 Jun 2024
Drug ApprovalClinical ResultPhase 3Accelerated Approval
Merck & Co.’s Keytruda (pembrolizumab) became the first anti-PD-1 therapy approved in combination with chemotherapy by the FDA for adults with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status. The company also noted that the clearance marks the third for Keytruda in endometrial cancer and the 40th indication for the product in the US.
The decision came shortly after the FDA authorised AstraZeneca’s PD-L1 inhibitor Imfinzi (durvalumab) in combination with chemotherapy as a treatment for adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). GSK’s PD-1-blocking antibody Jemperli (dostarlimab) is also approved in the US for the front-line treatment of advanced or recurrent dMMR endometrial cancer, while a decision is due by August 23 on whether to expand use to all adults with primary advanced or recurrent endometrial cancer.
Keytruda’s new approval was based on findings from the Phase III KEYNOTE-868 study, in which Keytruda plus carboplatin and paclitaxel, followed by Keytruda alone, reduced the risk of disease progression or death by 40% in patients whose cancer was mismatch repair proficient (pMMR) and by 70% those with dMMR tumours, compared to placebo with carboplatin and paclitaxel followed by placebo alone.
More to come.
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