Pembrolizumab plus chemotherapy in Japanese patients with persistent, recurrent or metastatic cervical cancer: Results from KEYNOTE‐826. Issue 11 (15th September 2022)

• Record Type: Journal Article
• Authors: Nishio, Shin; Yonemori, Kan; Usami, Tomoka; Minobe, Shinichiro; Yunokawa, Mayu; Iwata, Takashi; Okamoto, Aikou; Aoki, Yoichi; Itamochi, Hiroaki; Takekuma, Munetaka; Harano, Kenichi; Yamamoto, Keiko; Maruko, Takeshi; Ugai, Hiroyuki; Tekin, Cumhur; Colombo, Nicoletta; Fujiwara, Keiichi; Hasegawa, Kosei; Ushijima, Kimio
• Is Part Of: Cancer science. Volume 113:Issue 11(2022)
• Page Start: 3877
• Page End: 3887
• Publication Date: 2022-09-15
• Subjects: bevacizumab -- cervical cancer -- chemotherapy -- Japan -- pembrolizumab; Cancer -- Periodicals; Neoplasms -- Periodicals; Research -- Periodicals; Electronic journals; 616.994005
• DOI: 10.1111/cas.15479
• Languages: English
• ISSNs: 1347-9032

Abstract

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/m 2 + cisplatin 50 mg/m 2 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. Abstract : Pembrolizumab plus chemotherapy with or without bevacizumab demonstrated prolonged progression‐free survival and overall survival compared with chemotherapy in patients with persistent, recurrent, or metastatic cervical cancer in the phase 3 KEYNOTE‐826 study. In this subset analysis of patients enrolled in Japan in the KEYNOTE‐826 study, pembrolizumab plus chemotherapy with or without bevacizumab was associated with prolonged progression‐free survival and overall survival in this setting.