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<p>The phase 2 trial KEYNOTE-158 (<a href="https://clinicaltrials.gov/ct2/show/NCT02628067">NCT02628067</a>) evaluated pembrolizumab in microsatellite-instability-high and mismatch-repair-deficient (MSI-H/dMMR) noncolorectal tumors. With 373 participants (95% with baseline MSI/dMMR documentation) and 4.5 years of follow-up, the primary endpoint of overall response rate was 33.8%. Secondary endpoints of duration of response, overall survival and progression-free survival were 63.2, 19.8 and 4.0 months, respectively. Grade ≥3 treatment-related adverse events occurred in 50 (13%) participants. These results further support pembrolizumab use in MSI-H/dMMR tumors.</p>

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Pembrolizumab in microsatellite-instability-high and mismatch-repair-deficient advanced solid tumors: updated results of the KEYNOTE-158 trial

  • 期刊论文

  • 发表日期：

    2025年2月20日

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  • Aurelien Marabelle,
  • David M. O’Malley,
  • Andrew E. Hendifar,
  • Paolo A. Ascierto,
  • Daniel Motola-Kuba,
  • Nicolas Penel,
  • Philippe A. Cassier,
  • Giovanni Bariani,
  • Ana De Jesus-Acosta,
  • Toshihiko Doi,
  • Federico Longo,
  • Wilson H. Miller Jr,
  • Do-Youn Oh,
  • Maya Gottfried,
  • Lili Yao,
  • Fan Jin,
  • Alexander Gozman,
  • Michele Maio

摘要

The phase 2 trial KEYNOTE-158 (NCT02628067) evaluated pembrolizumab in microsatellite-instability-high and mismatch-repair-deficient (MSI-H/dMMR) noncolorectal tumors. With 373 participants (95% with baseline MSI/dMMR documentation) and 4.5 years of follow-up, the primary endpoint of overall response rate was 33.8%. Secondary endpoints of duration of response, overall survival and progression-free survival were 63.2, 19.8 and 4.0 months, respectively. Grade ≥3 treatment-related adverse events occurred in 50 (13%) participants. These results further support pembrolizumab use in MSI-H/dMMR tumors.