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Background <p>Pimitespib is a first-in-class heat shock protein 90 (HSP90) inhibitor, approved in Japan for the treatment of advanced gastrointestinal stromal tumors (GIST). This study aimed to characterize the incidence and time course of adverse drug reactions (ADRs) associated with pimitespib.</p> Methods <p>This was a post hoc analysis of pooled safety data from a phase 1 (NCT02965885), phase 2 (jRCT2080223127), and phase 3 (jRCT2080224033) study of pimitespib in patients with advanced GIST. The present analysis included Japanese study participants who received oral pimitespib 160&#xa0;mg once daily for 5&#xa0;days followed by 2&#xa0;days’ rest per week in 21-day cycles. Pooled safety outcomes included the incidence and severity of ADRs; ADRs leading to treatment modifications or discontinuation; and the time to ADR onset and resolution.</p> Results <p>In total, 119 patients were included. ADRs were reported in 114 patients (95.8%); gastrointestinal ADRs were most common (99 patients [83.2%]; most often diarrhea [75.6%]) and ocular ADRs occurred in 26 patients (21.8%; most often night blindness [11.8%]). Median time to first onset of any gastrointestinal ADR was 3.0&#xa0;days; the outcome of gastrointestinal ADRs was recovered/recovering in 61 patients (61.6%), with a median time to resolution of 44.0&#xa0;days. Median time to first onset of any ocular ADR was 19.0&#xa0;days; ocular ADRs were recovered/recovering in 20 patients (76.9%), with a median time to resolution of 21.0&#xa0;days.</p> Conclusions <p>This analysis suggests that most ADRs associated with pimitespib are manageable and reversible, thus supporting its use in patients with advanced GIST.</p>

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Pooled safety analysis of pimitespib for the treatment of patients with advanced gastrointestinal stromal tumors

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月20日

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  • Yukinori Kurokawa,
  • Noboru Yamamoto,
  • Yuko Hirano,
  • Naoki Arimura,
  • Chunlan Sun,
  • Toshihiko Doi

摘要

Background

Pimitespib is a first-in-class heat shock protein 90 (HSP90) inhibitor, approved in Japan for the treatment of advanced gastrointestinal stromal tumors (GIST). This study aimed to characterize the incidence and time course of adverse drug reactions (ADRs) associated with pimitespib.

Methods

This was a post hoc analysis of pooled safety data from a phase 1 (NCT02965885), phase 2 (jRCT2080223127), and phase 3 (jRCT2080224033) study of pimitespib in patients with advanced GIST. The present analysis included Japanese study participants who received oral pimitespib 160 mg once daily for 5 days followed by 2 days’ rest per week in 21-day cycles. Pooled safety outcomes included the incidence and severity of ADRs; ADRs leading to treatment modifications or discontinuation; and the time to ADR onset and resolution.

Results

In total, 119 patients were included. ADRs were reported in 114 patients (95.8%); gastrointestinal ADRs were most common (99 patients [83.2%]; most often diarrhea [75.6%]) and ocular ADRs occurred in 26 patients (21.8%; most often night blindness [11.8%]). Median time to first onset of any gastrointestinal ADR was 3.0 days; the outcome of gastrointestinal ADRs was recovered/recovering in 61 patients (61.6%), with a median time to resolution of 44.0 days. Median time to first onset of any ocular ADR was 19.0 days; ocular ADRs were recovered/recovering in 20 patients (76.9%), with a median time to resolution of 21.0 days.

Conclusions

This analysis suggests that most ADRs associated with pimitespib are manageable and reversible, thus supporting its use in patients with advanced GIST.