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Background <p>Garsorasib (D-1553), a highly selective, oral KRAS<sup>G12C</sup> inhibitor, has shown clinical efficacy in NSCLC and CRC and is under evaluation in pancreatic cancer.</p> Methods <p>Pancreatic cancer patients with KRAS G12C mutation were enroled and received garsorasib 600 mg twice daily treatment in two international, multicenter, open-label phase 1/2 trials (NCT04585035 and NCT05383898) with similar eligibility criteria. Their data were pooled for analyses of efficacy and safety endpoints.</p> Results <p>As of April 30, 2024, 24 KRAS G12C–mutated pancreatic cancer patients were enroled with a median follow-up of 8.9 months (range 1.1–22.9). Among 22 evaluable patients, the confirmed objective response rate (ORR) was 45.5% (95% CI, 24.4 to 67.8) with a median duration of response (DOR) of 6.4 months (95% CI, 4.2 to 16.4). The median progression-free survival (PFS) was 7.6 months (95% CI, 3.3 to 8.5) and the 6-month OS rate was 79.2% (95% CI, 57.0, 90.8). Treatment-related adverse events (TRAEs) occurred in 18 (75.0%) patients, including 6 (25.0%) with grade ≥3 events. No TRAEs led to treatment discontinuation. The safety profile was consistent with previous reports of garsorasib.</p> Conclusion <p>Garsorasib demonstrated encouraging antitumor activity and a tolerable safety profile in patients with KRAS G12C-mutated advanced pancreatic cancer.</p>

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Efficacy and safety of garsorasib in patients with KRAS G12C-mutated advanced pancreatic cancer

  • 期刊论文

  • 发表日期：

    2025年12月4日

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  • Noboru Yamamoto,
  • Dong Yan,
  • Vinod Ganju,
  • Xinfang Hou,
  • Hongming Pan,
  • Jianzhen Shan,
  • Liwei Wang,
  • Sang-We Kim,
  • Gary Richardson,
  • Rachel E. Sanborn,
  • Jingdong Zhang,
  • Ziyong Xiang,
  • Wenjia Wang,
  • Zhe Shi,
  • Ling Zhang,
  • Yaolin Wang,
  • Rui-Hua Xu

摘要

Background

Garsorasib (D-1553), a highly selective, oral KRASG12C inhibitor, has shown clinical efficacy in NSCLC and CRC and is under evaluation in pancreatic cancer.

Methods

Pancreatic cancer patients with KRAS G12C mutation were enroled and received garsorasib 600 mg twice daily treatment in two international, multicenter, open-label phase 1/2 trials (NCT04585035 and NCT05383898) with similar eligibility criteria. Their data were pooled for analyses of efficacy and safety endpoints.

Results

As of April 30, 2024, 24 KRAS G12C–mutated pancreatic cancer patients were enroled with a median follow-up of 8.9 months (range 1.1–22.9). Among 22 evaluable patients, the confirmed objective response rate (ORR) was 45.5% (95% CI, 24.4 to 67.8) with a median duration of response (DOR) of 6.4 months (95% CI, 4.2 to 16.4). The median progression-free survival (PFS) was 7.6 months (95% CI, 3.3 to 8.5) and the 6-month OS rate was 79.2% (95% CI, 57.0, 90.8). Treatment-related adverse events (TRAEs) occurred in 18 (75.0%) patients, including 6 (25.0%) with grade ≥3 events. No TRAEs led to treatment discontinuation. The safety profile was consistent with previous reports of garsorasib.

Conclusion

Garsorasib demonstrated encouraging antitumor activity and a tolerable safety profile in patients with KRAS G12C-mutated advanced pancreatic cancer.