First-line pembrolizumab plus chemotherapy versus chemotherapy alone for advanced esophageal cancer: 5-year extended follow-up in the Japanese subgroup of KEYNOTE-590.
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.
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.
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.
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.
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.
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.
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.
Authors
Kato Kato, Kojima Kojima, Hara Hara, Tsuji Tsuji, Yasui Yasui, Muro Muro, Satoh Satoh, Yatsuzuka Yatsuzuka, Sakata Sakata, Han Han, Doi Doi
View on Pubmed