British journal of cancer · 2025
Efficacy and safety of garsorasib in patients with KRAS G12C-mutated advanced pancreatic cancer.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеКлиническое исследование I фазыНазвание и аннотация: Перевод пока не подготовлен
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Yamamoto Noboru, Yan Dong, Ganju Vinod, Hou Xinfang, Pan Hongming, Shan Jianzhen, Wang Liwei, Kim Sang-We, Richardson Gary, Sanborn Rachel E, Zhang Jingdong, Xiang Ziyong, Wang Wenjia, Shi Zhe, Zhang Ling, Wang Yaolin, Xu Rui-Hua
Аннотация
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.
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.