FDA approves Keytruda regimen for advanced endometrial cancer
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The FDA approved the use of pembrolizumab in combination with chemotherapy for adults with primary advanced or recurrent endometrial carcinoma.
Pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — has been approved for several indications to treat gynecologic cancers, including two for advanced endometrial carcinoma. The application for this newest indication received priority review by the FDA.
The agency based its approval on results from the randomized KEYNOTE-868/NRG-GY018 trial assessing efficacy and safety of the regimen in 810 women with advanced or recurrent endometrial carcinoma.
The double-blind trial consisted of two cohorts based on mismatch repair status, with 222 patients in the mismatch repair-deficient group and 588 patients in the mismatch repair-proficient group.
Researchers randomly assigned patients in a 1:1 ratio to receive either placebo or 200 mg pembrolizumab every 3 weeks, followed by paclitaxel 175 mg/m2 and carboplatin area under the curve 5 mg/mL/min for six cycles, followed by either placebo or 400 mg pembrolizumab every 6 weeks for up to 14 cycles.
PFS served as the study’s major efficacy outcome measurement.
Median PFS has not been reached the pembrolizumab plus chemotherapy arm (95% CI, 30.7 to not reached) compared with 6.5 months (95% CI, 6.4-8.7) in the placebo arm (HR = 0.3; 95% CI, 0.19 - 0.48).
Among patients in the mismatch repair proficient cohort, study investigators reported median PFS of 11.1 months (95% CI, 8.7–13.5) in the investigative arm and 8.5 months (95% CI, 7.2–8.8) in the placebo arm (HR = 0.6; 95% CI, 0.46–0.78).
They also recommend a pembrolizumab dose of 200 mg every 3 weeks or 400 mg every 6 weeks until either disease progression, unacceptable toxicity or up to 24 months.
The safety profile for the pembrolizumab plus chemotherapy combination remained consistent with previously reported results using the agents in the regimen, although with a higher incidence of rash, according to a press release from the FDA.
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