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Pembrolizumab With Chemotherapy in Advanced or Recurrent Endometrial Cancer
Results of a phase 3 trial demonstrated the addition of pembrolizumab to standard chemotherapy resulted in significantly longer progression-free survival (PFS) among patients with advanced or recurrent endometrial cancer, compared with chemotherapy alone.
In this double-blinded phase 3 trial, a total of 816 patients with measurable disease, classified as stage III or IVA, or stage IVB or recurrent endometrial cancer were randomized on a 1-to-1 basis to receive standard chemotherapy (paclitaxel plus carboplatin) plus either pembrolizumab or placebo. Pembrolizumab or placebo administration was planned in 6 cycles every 3 weeks, which was followed by up to 14 maintenance cycles every 6 weeks. Patients were stratified based on whether they had mismatch repair–deficient (dMMR) or mismatch repair–proficient (pMMR) disease. The primary outcome was PFS in the two cohorts.
In the 12-month analysis, estimates of PFS in the dMMR cohort were 74% in the pembrolizumab group and 38% in the placebo group (hazard ratio [HR] , 0.30; 95% confidence interval [CI], 0.19 to 0.48; P < .001). In the pMMR cohort, median PFS was 13.1 months with pembrolizumab and 8.7 months with placebo (HR, 0.54; 95% CI, 0.41 to 0.71; P < .001). The documented adverse events were as expected for pembrolizumab and combination chemotherapy.
The study authors concluded, “In patients with advanced or recurrent endometrial cancer, the addition of pembrolizumab to standard chemotherapy resulted in significantly longer progression-free survival than with chemotherapy alone.”
Source:
Eskander R, Sill M, Beffa L, et al. Pembrolizumab plus chemotherapy in advanced endometrial cancer. N Engl J Med. 2023; 388:2159-2170. doi:10.1056/NEJMoa2302312
