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Background <p>After a median study follow-up of 36.6&#xa0;months, first-line pembrolizumab plus chemotherapy numerically improved overall survival (OS) and progression-free survival (PFS) versus placebo plus chemotherapy in Japanese participants with advanced esophageal cancer in the phase 3 KEYNOTE-590 study. The 5-year follow-up is presented.</p> Methods <p>Participants with previously untreated advanced esophageal cancer were randomly assigned 1:1 to pembrolizumab 200&#xa0;mg or placebo every 3&#xa0;weeks up to 35 cycles plus chemotherapy (cisplatin 80&#xa0;mg/m<sup>2</sup> and 5-fluorouracil 800&#xa0;mg/m<sup>2</sup>/day). Primary end points were OS and PFS per RECIST v1.1 by investigator; objective response rate (ORR) and safety were secondary. The data cutoff date was July 10, 2023.</p> Results <p>In total, 141 of 794... participants were enrolled in Japan. Median study follow-up was 60.6&#xa0;months (range, 53.8–69.7). Median OS was 17.7&#xa0;months (95% CI, 13.9–28.5) with pembrolizumab plus chemotherapy versus 11.7&#xa0;months (95% CI, 9.5–19.0) with placebo plus chemotherapy (HR, 0.65; 95% CI, 0.45–0.94); 60-month rates were 24.0% and 8.5%. Median PFS was 6.3&#xa0;months (95% CI, 6.0–8.2) versus 6.0&#xa0;months (95% CI, 4.2–6.2) (HR, 0.57; 95% CI, 0.39–0.83); 60-month rates were 16.9% and 0%. ORRs were 56.8% (95% CI, 44.7–68.2) and 38.8% (95% CI, 27.1–51.5). The median DOR was 8.3&#xa0;months for pembrolizumab plus chemotherapy and 6.1&#xa0;months for placebo plus chemotherapy. No new treatment-related adverse events occurred since the prior analysis.</p> Conclusions <p>After a median follow-up of 5&#xa0;years, pembrolizumab plus chemotherapy continues to provide long-term survival outcomes among Japanese participants with advanced esophageal cancer. No new safety signals were observed.</p> <p><i>Clinical trial registration</i> ClinicalTrials.gov, NCT03189719.</p>

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First-line pembrolizumab plus chemotherapy versus chemotherapy alone for advanced esophageal cancer: 5-year extended follow-up in the Japanese subgroup of KEYNOTE-590

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  • 发表日期：

    2026年4月28日

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  • Ken Kato,
  • Takashi Kojima,
  • Hiroki Hara,
  • Akihito Tsuji,
  • Hisateru Yasui,
  • Kei Muro,
  • Taroh Satoh,
  • Naoyoshi Yatsuzuka,
  • Tomoko Sakata,
  • Shirong Han,
  • Toshihiko Doi

摘要

Background

After a median study follow-up of 36.6 months, first-line pembrolizumab plus chemotherapy numerically improved overall survival (OS) and progression-free survival (PFS) versus placebo plus chemotherapy in Japanese participants with advanced esophageal cancer in the phase 3 KEYNOTE-590 study. The 5-year follow-up is presented.

Methods

Participants with previously untreated advanced esophageal cancer were randomly assigned 1:1 to pembrolizumab 200 mg or placebo every 3 weeks up to 35 cycles plus chemotherapy (cisplatin 80 mg/m2 and 5-fluorouracil 800 mg/m2/day). Primary end points were OS and PFS per RECIST v1.1 by investigator; objective response rate (ORR) and safety were secondary. The data cutoff date was July 10, 2023.

Results

In total, 141 of 794... participants were enrolled in Japan. Median study follow-up was 60.6 months (range, 53.8–69.7). Median OS was 17.7 months (95% CI, 13.9–28.5) with pembrolizumab plus chemotherapy versus 11.7 months (95% CI, 9.5–19.0) with placebo plus chemotherapy (HR, 0.65; 95% CI, 0.45–0.94); 60-month rates were 24.0% and 8.5%. Median PFS was 6.3 months (95% CI, 6.0–8.2) versus 6.0 months (95% CI, 4.2–6.2) (HR, 0.57; 95% CI, 0.39–0.83); 60-month rates were 16.9% and 0%. ORRs were 56.8% (95% CI, 44.7–68.2) and 38.8% (95% CI, 27.1–51.5). The median DOR was 8.3 months for pembrolizumab plus chemotherapy and 6.1 months for placebo plus chemotherapy. No new treatment-related adverse events occurred since the prior analysis.

Conclusions

After a median follow-up of 5 years, pembrolizumab plus chemotherapy continues to provide long-term survival outcomes among Japanese participants with advanced esophageal cancer. No new safety signals were observed.

Clinical trial registration ClinicalTrials.gov, NCT03189719.