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sugemalimab或安慰剂加化疗作为转移性NSCLC的一线治疗

原文发布日期：2023-06-15

英文摘要：

摘要翻译：

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文章：

sugemalimab或安慰剂加化疗作为转移性NSCLC的一线治疗

sugemalimab or placebo plus chemotherapy as first-line treatment for metastatic NSCLC

原文发布日期：2023-06-15

英文摘要：

The randomized, double-blinded, multi-center, phase III GEMSTONE-302 (NCT03789604) study evaluated the efficacy and safety of sugemalimab versus placebo in combination with chemotherapy as first-line treatment for metastatic non-small-cell lung cancer (NSCLC). In this study, 479 treatment-naive patients with stage IV squamous or non-squamous NSCLC without known EGFR sensitizing mutations, ALK, ROS1 or RET fusions were randomized (2:1) to receive 1,200 mg of sugemalimab (n = 320) or placebo (n = 159) every 3 weeks in combination with platinum-based chemotherapy for up to four cycles, followed by maintenance therapy with sugemalimab or placebo for squamous NSCLC and sugemalimab or placebo plus pemetrexed for non-squamous NSCLC. Placebo-treated patients could cross over to receive sugemalimab monotherapy on disease progression. The primary endpoint was investigator-assessed progression-free survival (PFS) and the secondary endpoints included overall survival (OS) and objective response rate. Sugemalimab plus chemotherapy has demonstrated significant PFS prolongation in the primary analysis as reported previously. As of 22 November 2021, the prespecified interim OS analysis showed significant improvement with the addition of sugemalimab to chemotherapy (median OS = 25.4 versus 16.9 months; hazard ratio = 0.65; 95% confidence interval = 0.50–0.84; P = 0.0008). Sugemalimab plus chemotherapy provided superior PFS and OS compared to placebo plus chemotherapy, supporting the use of sugemalimab as a first-line treatment option for metastatic NSCLC.

摘要翻译：

这项随机、双盲、多中心iii期临床研究（name: GEMSTONE-302; trial id: NCT03789604）评估了sugemalimab联合化疗作为转移性非小细胞肺癌（nsclc）一线治疗的有效性和安全性。该研究招募了479例治疗-naïve的nsclc患者，这些患者尚未知具有egfr敏感突变、ALK、ros1或ret融合的晚期鳞状或非鳞状细胞癌患者。他们随机分为2:1的比例接受每3周静脉注射1,200 mg sugemalimab（n=320）或安慰剂（n=159），结合铂类化疗治疗至最多四个周期后，进入维持治疗：对鳞状细胞癌患者使用sugemalimab或安慰剂，对非鳞状细胞癌患者则采用sugemalimab联合pemetrexed。安慰剂接受者在疾病进展时可交叉换用单药sugemalimab治疗。研究的主要终点是研究者评估的无进展生存期（pfs），次要终点包括总生存期（os）和客观缓解率。此前报道过的主要分析显示，sugemalimab联合化疗已显示显著延长无进展生存期的效果。截至2021年11月22日，预先指定的中区间总生存期分析显示，加入sugemalimab后，化疗的总生存期有显著改善（median os=25.4 vs 16.9个月；hazard ratio=0.65；95% confidence interval=0.50–0.84；p=0.0008）。sugemalimab联合化疗相比安慰剂联合化疗在无进展生存期和总生存期方面均更优，支持将sugemalimab作为转移性nsclc一线治疗方案的使用。