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🌱 來自: Metastatic Colon Cancer

KEYNOTE-177

Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer | NEJM

• at ↣ the second interim analysis, after a median follow-up (from randomization to data cutoff) of 32.4 months (range, 24.0 to 48.3), pembrolizumab was superior to chemotherapy with respect to

  • progression-free survival
  • (median, 16.5 vs. 8.2 months; hazard ratio, 0.60; 95% confidence interval [CI], 0.45 to 0.80; P=0.0002).

• The estimated restricted mean survival after 24 months of follow-up was 13.7 months (range, 12.0 to 15.4) as compared with 10.8 months (range, 9.4 to 12.2).

• As of the data cutoff date, 56 patients in the pembrolizumab group and 69 in the chemotherapy group had died.

• Data on overall survival were still evolving (66% of required events had occurred) and remain blinded until the final analysis.

• An overall response (complete or partial response), as evaluated with Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, was observed in 43.8% of the patients in the pembrolizumab group and 33.1% in the chemotherapy group.

• Among patients with an overall response, 83% in the pembrolizumab group, as compared with 35% of patients in the chemotherapy group, had ongoing responses at ↣ 24 months.

• Treatment-related adverse events of grade 3 or higher occurred in 22% of the patients in the pembrolizumab group, as compared with 66% (including one patient who died) in the chemotherapy group.