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Updated: Aug 14, 2025

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Neoadjuvant Pembrolizumab in Localized Microsatellite Instability High/Deficient Mismatch Repair Solid Tumors.

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Neoadjuvant pembrolizumab is safe and effective for microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) cancers, showing high response rates and supporting organ-sparing approaches in localized tumors.

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Area of Science:

  • Oncology
  • Immunotherapy
  • Cancer Research

Background:

  • Pembrolizumab is established for advanced MSI-H/dMMR solid tumors.
  • Its efficacy in the neoadjuvant setting for localized MSI-H/dMMR tumors is less understood.

Purpose of the Study:

  • To evaluate the safety and efficacy of neoadjuvant pembrolizumab in patients with localized unresectable or high-risk resectable MSI-H/dMMR tumors.
  • To assess pathologic complete response (pCR) and overall response rates.

Main Methods:

  • Phase II, open-label, single-center trial.
  • Pembrolizumab 200 mg every 3 weeks for 6 months, followed by surgery.
  • Coprimary endpoints: safety and pCR. Secondary endpoints: response rate, organ-sparing outcomes.

Main Results:

  • 35 patients enrolled (27 colorectal, 8 non-colorectal).
  • Best overall response rate was 82% among 33 evaluable patients.
  • pCR rate was 65% in 17 patients who underwent surgery. No new safety signals observed.

Conclusions:

  • Neoadjuvant pembrolizumab is safe in dMMR/MSI-H cancers.
  • Achieved high pathologic, radiographic, and endoscopic response rates.
  • Supports potential for organ-sparing strategies in these cancers.