Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China
Department of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China.
J Immunother Cancer. 2024 Nov 27;12(11):e009240. doi: 10.1136/jitc-2024-009240.
CameL phase 3 study demonstrated the superiority of camrelizumab plus chemotherapy over chemotherapy alone for progression-free survival in patients with previously untreated advanced non-squamous non-small-cell lung cancer (NSCLC) without / alterations. Here, we present the 5-year outcomes.
Patients were randomized (1:1) and received 4-6 cycles of camrelizumab plus carboplatin and pemetrexed (n=205) or carboplatin and pemetrexed (n=207) every 3 weeks, followed by maintenance camrelizumab plus pemetrexed or pemetrexed only. Crossover from chemotherapy group to camrelizumab monotherapy was permitted after disease progression.
Median time from randomization to data cut-off was 65.2 months (range, 59.7-72.2). HR for overall survival (OS) was 0.74 (95% CI 0.58 to 0.93; one-sided p=0.0043), and was 0.62 (95% CI 0.49 to 0.79; one-sided p<0.0001) after adjustment for crossover. Five-year OS rates were 31.2% (95% CI 24.7% to 37.9%) with camrelizumab plus chemotherapy versus 19.3% (95% CI 13.9% to 25.3%) with chemotherapy alone. Among the 33 patients who completed 2 years of camrelizumab, 5-year OS rate was 84.3% (95% CI 66.4% to 93.2%), and 5-year duration of response rate was 46.5% (95% CI 24.9% to 65.6%) in the 32 responders. No new safety signals were noted.
Camrelizumab plus carboplatin and pemetrexed as first-line therapy continued to demonstrate long-term OS benefit over carboplatin and pemetrexed, with manageable toxicity. Patients who completed 2 years of camrelizumab had enduring response and impressive OS. Current 5-year updated analysis further supports camrelizumab plus carboplatin and pemetrexed as a standard-of-care for previously untreated advanced non-squamous NSCLC without / alterations.
NCT03134872.
CameL 三期研究表明，在未经治疗的晚期非鳞状非小细胞肺癌（NSCLC）患者中，与化疗相比，卡瑞利珠单抗联合化疗在无/改变的患者中可显著提高无进展生存期。在此，我们报告了 5 年的结果。
患者按 1:1 随机分组，分别接受卡瑞利珠单抗联合卡铂和培美曲塞（n=205）或卡铂和培美曲塞（n=207）治疗，每 3 周一次，随后接受卡瑞利珠单抗联合培美曲塞或培美曲塞维持治疗。疾病进展后允许化疗组交叉至卡瑞利珠单抗单药治疗。
从随机分组到数据截止的中位时间为 65.2 个月（范围，59.7-72.2）。总生存期（OS）的 HR 为 0.74（95%CI 0.58-0.93；单侧 p=0.0043），调整交叉后为 0.62（95%CI 0.49-0.79；单侧 p<0.0001）。卡瑞利珠单抗联合化疗组的 5 年 OS 率为 31.2%（95%CI 24.7%-37.9%），化疗组为 19.3%（95%CI 13.9%-25.3%）。在完成 2 年卡瑞利珠单抗治疗的 33 例患者中，5 年 OS 率为 84.3%（95%CI 66.4%-93.2%），32 例应答者的 5 年缓解持续时间率为 46.5%（95%CI 24.9%-65.6%）。未发现新的安全性信号。
卡瑞利珠单抗联合卡铂和培美曲塞作为一线治疗，与卡铂和培美曲塞相比，继续显示出长期的 OS 获益，且毒性可管理。完成 2 年卡瑞利珠单抗治疗的患者具有持久的反应和令人印象深刻的 OS。目前的 5 年更新分析进一步支持卡瑞利珠单抗联合卡铂和培美曲塞作为未经治疗的晚期非鳞状 NSCLC 患者的标准治疗方案。
NCT03134872。
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