Anti-programmed death-1 agents are an established option for advanced melanoma, but the anti-programmed death-ligand 1 (anti-PD-L1) antibody atezolizumab, an agent approved for the treatment of multiple solid tumors, was not previously evaluated. This phase 1b study cohort (NCT03178851; cohort C) evaluated first-line atezolizumab 1,200 mg every 3 weeks in adults with BRAF^V600 wild-type, histologically confirmed, advanced or metastatic melanoma. The co-primary end points were confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors v1.1 and disease control rate (DCR = complete response [CR] +partial response [PR] +stable disease [SD] at 16 weeks). Of 52 enrolled patients, most had lactate dehydrogenase levels lower than the upper limit of normal (77%) and PD-L1-positive tumors (55%). Investigator-assessed confirmed ORR was 35% (95% CI, 22%-49%) and included three CRs (6%) and 15 PRs (29%); DCR was 46%. Median investigator-assessed progression-free survival was 3.7 months (95% CI, 2.1–7.3). The most common any-grade adverse events were anemia (27%), headache (19%), hypertension (19%), constipation (17%), diarrhea (17%), hypothyroidism (17%), asthenia (15%), and pain in extremity (15%). First-line atezolizumab monotherapy is safe and tolerable and has antitumor activity in patients with BRAF^V600 wild-type advanced or metastatic melanoma.

中文翻译：

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晚期 BRAFV600 野生型黑色素瘤患者的一线阿特珠单抗单药治疗

抗程序性死亡1药物是晚期黑色素瘤的既定选择，但抗程序性死亡配体1（抗PD-L1）抗体atezolizumab是一种获准用于治疗多种实体瘤的药物，此前并未进行评估。该 1b 期研究队列（NCT03178851；队列 C）评估了BRAF ^V600成人每 3 周使用 1,200 mg 一线阿特珠单抗野生型、组织学证实的、晚期或转移性黑色素瘤。共同主要终点是根据实体瘤 v1.1 中反应评估标准的客观反应率 (ORR) 和疾病控制率（DCR = 完全反应 [CR] + 部分反应 [PR] + 疾病稳定 [SD] 在 16周）。在 52 名入组患者中，大多数患者的乳酸脱氢酶水平低于正常 (77%) 和 PD-L1 阳性肿瘤 (55%) 的上限。研究者评估确认的 ORR 为 35%（95% CI，22%-49%），包括 3 个 CR（6%）和 15 个 PR（29%）；DCR 为 46%。研究者评估的中位无进展生存期为 3.7 个月（95% CI，2.1-7.3）。最常见的任何级别的不良事件是贫血 (27%)、头痛 (19%)、高血压 (19%)、便秘 (17%)、腹泻 (17%)、甲状腺功能减退 (17%)、虚弱 (15%)和四肢疼痛（15%）。BRAF ^V600野生型晚期或转移性黑色素瘤。