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In the global, randomized, phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 (NCT04221945) study, pembrolizumab (pembro) + concurrent chemoradiotherapy (CCRT) showed a statistically significant improvement over placebo (pbo) + CCRT in PFS (median PFS, not reached in either group; hazard ratio HR, 0.70 95% CI, 0.55–0.89; P=0.0020) and a favorable trend for improved OS vs pbo + CCRT (median OS not reached in either group; HR, 0.73 95% CI, 0.49–1.07) in patients with high-risk locally advanced cervical cancer (LACC) at the first interim analysis. We present results for patients enrolled in East Asia. Eligible patients had newly diagnosed, previously untreated, high-risk LACC (FIGO 2014 stage IB2-IIB with node-positive disease or stage III-IVA regardless of lymph node status). Patients were randomly assigned (1:1) to receive 5 cycles of pembro 200 mg or pbo Q3W + CCRT, followed by 15 cycles of pembro 400 mg or pbo Q6W. CCRT included 5 cycles (with optional 6th dose) of cisplatin 40 mg/m2 QW + external beam radiotherapy, then brachytherapy. Primary endpoints were PFS per RECIST v1.1 by investigator assessment and OS. No alpha was allocated to this exploratory analysis in the East Asia subgroup. 299 patients were enrolled in East Asia (China, n=149; Japan, n=90; Republic of Korea, n=26; Thailand, n=20; Taiwan, n=14): pembro + CCRT, n=153; pbo + CCRT, n=146. Median follow-up at database cutoff (Jan 9, 2023) was 19.3 (range, 0.9–31.0) months. Median PFS was not reached in either treatment group (HR, 0.55 95% CI, 0.35–0.88); 24-month PFS rate was 77.6% in the pembro + CCRT group and 59.8% in the pbo + CCRT group. Grade ≥3 treatment-related AEs occurred in 78.3% of patients in the pembro + CCRT group and 77.4% in the pbo + CCRT group; none were grade 5. Immune-mediated AEs occurred in 43.4% and 10.3% of patients, respectively. Consistent with the global analysis, pembro + CCRT demonstrated PFS benefit vs pbo + CCRT, with manageable safety in patients with high-risk LACC enrolled in East Asia. These results suggest pembro + CCRT may be considered as a new treatment option for patients with high-risk LACC in East Asia.
Xiang et al. (Sat,) studied this question.