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Randomized Controlled Trial
. 2022 Nov;113(11):3877-3887.
doi: 10.1111/cas.15479. Epub 2022 Sep 15.

Pembrolizumab plus chemotherapy in Japanese patients with persistent, recurrent or metastatic cervical cancer: Results from KEYNOTE-826

Shin Nishio  1 , Kan Yonemori  2 , Tomoka Usami  3 , Shinichiro Minobe  4 , Mayu Yunokawa  5 , Takashi Iwata  6 , Aikou Okamoto  7 , Yoichi Aoki  8 , Hiroaki Itamochi  9 , Munetaka Takekuma  10 , Kenichi Harano  11 , Keiko Yamamoto  12 , Takeshi Maruko  12 , Hiroyuki Ugai  12 , Cumhur Tekin  13 , Nicoletta Colombo  14 , Keiichi Fujiwara  15 , Kosei Hasegawa  15 , Kimio Ushijima  1
Affiliations
Randomized Controlled Trial

Pembrolizumab plus chemotherapy in Japanese patients with persistent, recurrent or metastatic cervical cancer: Results from KEYNOTE-826

Shin Nishio et al. Cancer Sci. 2022 Nov.

Abstract

Pembrolizumab plus chemotherapy with or without bevacizumab demonstrated prolonged progression-free survival (PFS) and overall survival (OS) versus chemotherapy in patients with persistent, recurrent, or metastatic cervical cancer in the phase 3, randomized, double-blind, placebo-controlled KEYNOTE-826 study. We report outcomes in patients enrolled in Japan. Patients received pembrolizumab 200 mg or placebo Q3W for up to 35 cycles plus chemotherapy (paclitaxel 175 mg/m2 + cisplatin 50 mg/m2 or carboplatin AUC 5) with or without bevacizumab 15 mg/kg. Dual primary endpoints were PFS per RECIST v1.1 by investigator assessment and OS in the global population; these were evaluated in patients with tumors with PD-L1 combined positive score (CPS) ≥1, all-comers, and PD-L1 CPS ≥10. Fifty-seven patients from Japan were randomized (pembrolizumab plus chemotherapy, n = 35; placebo plus chemotherapy, n = 22). Pembrolizumab plus chemotherapy improved PFS versus placebo plus chemotherapy in patients with PD-L1 CPS ≥1 (n = 51; hazard ratio [HR; 95% CI], 0.36 [0.16-0.77]), all-comers (n = 57; 0.45 [0.22-0.90]), and patients with PD-L1 CPS ≥10 (n = 25; 0.36 [0.12-1.07]). HRs (95% CI) for OS were 0.38 (0.14-1.01), 0.41 (0.17-1.00), and 0.37 (0.10-1.30), respectively. Incidence of grade 3-5 AEs was 94% in the pembrolizumab group and 100% in the placebo group. Consistent with findings in the global KEYNOTE-826 study, pembrolizumab plus chemotherapy with or without bevacizumab may prolong survival versus placebo plus chemotherapy with or without bevacizumab and had a manageable safety profile in Japanese patients with persistent, recurrent, or metastatic cervical cancer.

Keywords: Japan; bevacizumab; cervical cancer; chemotherapy; pembrolizumab.

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Figures

FIGURE 1
FIGURE 1
Patient disposition in the Japan subset
FIGURE 2
FIGURE 2
Progression‐free survival (PFS) per RECIST version 1.1 by investigator in (A) patients with programmed death ligand 1 (PD‐L1) combined positive score (CPS) ≥1 tumors, (B) all‐comer patients, and (C) patients with PD‐L1 CPS ≥10 tumors. HR, hazard ratio; NR, not reached
FIGURE 3
FIGURE 3
Overall survival (OS) in (A) patients with programmed death ligand 1 (PD‐L1) combined positive score (CPS) ≥1 tumors, (B) all‐comer patients, and (C) patients with PD‐L1 CPS ≥10 tumors. HR, hazard ratio; NR, not reached; PFS, progression‐free survival
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