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<p>Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal cancers, driven by KRAS mutations long deemed “undruggable”. We conducted a meta-analysis of seven early phase cohorts (<i>n</i> = 695) that evaluated KRAS-targeted therapies in patients with PDAC. The pooled objective response rate was 29% (95% CI 24–35%), indicating promising activity in refractory PDAC, with consistent estimates across studies (I<sup>2</sup> = 5.7%). Gastrointestinal toxicities were among the most common adverse events, with pooled incidences of 40% for diarrhea and 41% for nausea in all patients treated with KRAS-targeted agents. These findings validate direct KRAS inhibition as a breakthrough concept in PDAC but are tempered by modest durability, risk of bias, and limitations of early phase designs, underscoring the need for biomarker-guided, rigorously designed clinical trials.</p>

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Efficacy and safety signals from early-phase studies of KRAS inhibition in pancreatic cancer

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月11日

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  • Kathlen Oliveira Martins Tiede,
  • Maria Fernanda Teixeira,
  • Mariana Moura,
  • Ohana Chiaini,
  • Fernando Moura,
  • Mohamad Bassam Sonbol,
  • Mitesh Borad,
  • Tanios Bekaii-Saab,
  • Pedro Luiz Serrano Uson Junior

摘要

Pancreatic ductal adenocarcinoma (PDAC) remains one of the most lethal cancers, driven by KRAS mutations long deemed “undruggable”. We conducted a meta-analysis of seven early phase cohorts (n = 695) that evaluated KRAS-targeted therapies in patients with PDAC. The pooled objective response rate was 29% (95% CI 24–35%), indicating promising activity in refractory PDAC, with consistent estimates across studies (I2 = 5.7%). Gastrointestinal toxicities were among the most common adverse events, with pooled incidences of 40% for diarrhea and 41% for nausea in all patients treated with KRAS-targeted agents. These findings validate direct KRAS inhibition as a breakthrough concept in PDAC but are tempered by modest durability, risk of bias, and limitations of early phase designs, underscoring the need for biomarker-guided, rigorously designed clinical trials.