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25.03.2019 | Original Article | Ausgabe 4/2019 Open Access

Gastric Cancer 4/2019

Pembrolizumab alone or in combination with chemotherapy as first-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma: results from the phase II nonrandomized KEYNOTE-059 study

Zeitschrift:
Gastric Cancer > Ausgabe 4/2019
Autoren:
Yung-Jue Bang, Yoon-Koo Kang, Daniel V. Catenacci, Kei Muro, Charles S. Fuchs, Ravit Geva, Hiroki Hara, Talia Golan, Marcelo Garrido, Shadia I. Jalal, Christophe Borg, Toshihiko Doi, Harry H. Yoon, Mary J. Savage, Jiangdian Wang, Rita P. Dalal, Sukrut Shah, Zev A. Wainberg, Hyun Cheol Chung
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s10120-018-00909-5) contains supplementary material, which is available to authorized users.
Rita P. Dalal was affiliated with Medical Oncology, Merck & Co., Inc., Kenilworth, NJ, USA, at the time of the study.
Yung-Jue Bang, Yoon-Koo Kang and Hyun Cheol Chung contributed equally.

Abstract

Background

The multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, evaluating first-line therapy, are presented.

Methods

Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/m2 on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/m2 on days 1–5 of each 3-week cycle (or capecitabine 1000 mg/m2 twice daily in Japan). Primary end points were safety (combination therapy) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review, and safety (monotherapy).

Results

In the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8–24.1) and 17.5 months (range 1.7–20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3–5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% [95% confidence interval (CI), 38.7–78.9] (combination therapy) and 25.8% (95% CI 11.9–44.6) (monotherapy).

Conclusions

Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma.

Clinical Trial

ClinicalTrials.gov NCT02335411

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