Pembrolizumab plus chemotherapy with or without bevacizumab in East Asian participants with persistent, recurrent, or metastatic cervical cancer: results from KEYNOTE-826 final analysis

Abstract

Objective: In the phase 3 KEYNOTE-826 study (NCT03635567), pembrolizumab plus chemotherapy with or without bevacizumab significantly improved progression-free survival (PFS) and overall survival (OS) in participants with persistent, recurrent, or metastatic cervical cancer. We report an exploratory analysis of outcomes for participants enrolled in East Asia based on the final analysis of KEYNOTE-826.

Methods: Participants were randomized 1:1 to receive pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles. All participants received chemotherapy with paclitaxel and cisplatin or carboplatin for up to 6 cycles, and optionally received bevacizumab at the investigator's discretion. PFS and OS were dual primary endpoints.

Results: Ninety-seven participants from East Asia were enrolled in the intention-to-treat population. At data cutoff (October 3, 2022), in the intention-to-treat population, median PFS in the pembrolizumab plus chemotherapy and placebo plus chemotherapy groups was 18.0 and 10.4 months, respectively (hazard ratio [HR]=0.42; 95% confidence interval [CI]=0.23-0.77); median OS was not reached and 20.4 months, respectively (HR=0.53; 95% CI=0.28-0.99). In the programmed cell death ligand 1 combined positive score (CPS) ≥1 population, median PFS was 29.3 and 10.9 months, respectively (HR=0.36; 95% CI=0.19-0.68); median OS was not reached and 17.4 months, respectively (HR=0.43; 95% CI=0.22-0.86). The most common adverse events with pembrolizumab plus chemotherapy versus placebo plus chemotherapy were alopecia (75% vs. 68%) and anemia (67% vs. 65%).

Conclusion: These data support the use of pembrolizumab plus chemotherapy with or without bevacizumab for the treatment of persistent, recurrent, or metastatic cervical cancer in East Asian patients.

Trial registration: ClinicalTrials.gov Identifier: NCT03635567.

Keywords: Cervical Cancer; East Asia; Pembrolizumab.

Fig. 1. Flow diagram of East Asian participants from KEYNOTE-826.

Data cutoff date: October 3, 2022.

Fig. 2. PFS per RECIST version 1.1 as assessed by the investigator in the ITT and PD-L1 CPS ≥1 populations.

(A) ITT and (B) PD-L1 CPS ≥1 populations. Data cutoff date: October 3, 2022. CI, confidence interval; CPS, combined positive score; HR, hazard ratio; ITT, intention-to-treat; NR, not reached; PD-L1, programmed cell death ligand 1; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors.

Fig. 3. OS in the ITT and PD-L1 CPS ≥1 populations.

(A) ITT and (B) PD-L1 CPS ≥1 populations. Data cutoff date: October 3, 2022. CI, confidence interval; CPS, combined positive score; HR, hazard ratio; ITT, intention-to-treat; NR, not reached; OS, overall survival; PD-L1, programmed cell death ligand 1.