Garsorasib in patients with KRAS G12C-mutated non-small-cell lung cancer: A pooled analysis of phase 1/2 study.
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Song Zhengbo, Li Ziming, Zhang Yiping, Wang Pingli, Jiang Liyan, Zhao Yanqiu, Zhou Jianying, Wang Xicheng, Zhuang Wu, Shi Jianhua, Huang Dingzhi, Dang Xiaomin, Cang Shundong, Gong Yi, Jin Shi, Li Weiwei, Dong Xiaorong, Zhang Junping, Zhao Mingfang, Meng Xiangjiao, Liu Xuewen, Fang Jian, Wu Ping, Lu Junguo, Zhang Liangming, Yang Junquan, Wang Xiang, Luo Hui, Cui Jiuwei, Zhang Zhihong, Wang Jing, Li Gaofeng, Wu Lin, Yu Yan, Fang Yong, Lv Dongqing, Yang Weihua, Chen Lingxiang, Yang Nong, Li Kunyan, Ma Rui, Wang Mingxi, Zhou Huan, Hu Sheng, Li Qingshan, Zhuang Zhixiang, Cao Baoshan, Zhu Wei, Xu Chunwei, Wang Wenjia, Xiang Ziyong, Shi Zhe, Wang Yaolin, Zhang Ling, Lu Shun
Аннотация
METHODS: This multicenter, open-label phase 1/2 study enrolled patients with KRAS G12C-mutated, locally advanced or metastatic NSCLC. The primary endpoints for phase 1 were safety and tolerability and for phase 2 objective response rate (ORR) by a blinded independent review committee per RECIST version 1.1. Data was pooled from patients who received garsorasib 600 mg twice daily.
RESULTS: This pooled dataset included 189 patients (N = 66 in phase 1 and N = 123 in phase 2). The median pooled follow-up time was 13.0 months (IQR: 6.7-17.5). The objective response rate was 48.1 % (95 %CI: 40.8-55.5), and disease control rate was 87.8 % (95 %CI: 82.3-92.1). The median duration of response was 12.45 months (95 % CI: 8.31, 14.49), the median progression-free survival was 9.07 months (95 %CI: 7.39-9.76), and the median overall survival was 14.19 months (95 %CI: 13.08-17.54). Treatment-related adverse events of any grade occurred in 96.3 % of patients, with grade ≥ 3 in 49.2 % of patients. No new safety findings were observed, and most of the adverse events were controllable.
CONCLUSION: This pooled analysis confirmed the robust efficacy and manageable safety of garsorasib in KRAS G12C-mutated NSCLC.
GOV IDENTIFIER: NCT05383898.