Department of Medicine, Memorial Sloan Kettering Cancer Center, New York; Department of Medicine, Weill Cornell Medical College, New York, USA.
Université Paris Cité, AP-HP Dermato-Oncology and Clinical Investigation Center, Cancer Institute AP-HP. Nord Paris Cité, INSERM U976, Saint Louis Hospital, Paris, France.
ESMO Open. 2024 May;9(5):103461. doi: 10.1016/j.esmoop.2024.103461. Epub 2024 May 13.
Results from the JAVELIN Merkel 200 study led to the approval of avelumab [an anti-programmed death-ligand 1 (PD-L1) antibody] for the treatment of metastatic Merkel cell carcinoma (mMCC) in multiple countries and its inclusion in the treatment guidelines as a preferred or recommended therapy in this setting. Here, we report 4-year follow-up results from the cohort of patients with mMCC who received avelumab as first-line treatment.
In part B of JAVELIN Merkel 200, a single-arm, open-label, phase II study, patients with mMCC who had not received prior systemic therapy for metastatic disease received avelumab 10 mg/kg via intravenous infusion every 2 weeks until confirmed disease progression, unacceptable toxicity, or withdrawal. In this analysis, long-term overall survival (OS), patient disposition, and subsequent treatment were analyzed.
In total, 116 patients received first-line avelumab. At the data cutoff (2 February 2022), the median follow-up was 54.3 months (range 48.0-69.7 months). Seven patients (6.0%) remained on treatment and an additional 21 patients remained in follow-up (18.1%); 72 patients (62.1%) had died. The median OS was 20.3 months [95% confidence interval (CI) 12.4-42.0 months], with a 4-year OS rate of 38% (95% CI 29% to 47%). In patients with PD-L1+ or PD-L1- tumors, the 4-year OS rate was 48% (95% CI 26% to 67%) and 35% (95% CI 25% to 45%), respectively. In total, 48 patients (41.4%) received poststudy anticancer drug therapy, most commonly etoposide (20.7%), carboplatin (19.0%), and avelumab (12.1%).
Avelumab first-line monotherapy in patients with mMCC resulted in meaningful long-term OS, which compared favorably with historical studies of first-line chemotherapy. These results further support the role of avelumab as a standard of care for patients with mMCC.
JAVELIN Merkel 200 研究的结果导致avelumab[一种抗程序性死亡配体 1（PD-L1）抗体]在多个国家被批准用于治疗转移性 Merkel 细胞癌（mMCC），并将其纳入该治疗领域的首选或推荐治疗方法。在此，我们报告了接受avelumab 作为一线治疗的 mMCC 患者队列的 4 年随访结果。
在 JAVELIN Merkel 200 的 B 部分中，这是一项单臂、开放标签、II 期研究，未经系统治疗转移性疾病的 mMCC 患者接受avelumab 10mg/kg 静脉输注，每 2 周一次，直至确认疾病进展、无法耐受的毒性或停药。在这项分析中，分析了长期总生存（OS）、患者转归和随后的治疗情况。
共 116 例患者接受了一线 avelumab 治疗。在数据截止日期（2022 年 2 月 2 日），中位随访时间为 54.3 个月（范围为 48.0-69.7 个月）。7 例患者（6.0%）仍在接受治疗，另外 21 例患者仍在随访（18.1%）；72 例患者（62.1%）死亡。中位 OS 为 20.3 个月[95%置信区间（CI）12.4-42.0 个月]，4 年 OS 率为 38%（95%CI 29%-47%）。在 PD-L1+或 PD-L1-肿瘤患者中，4 年 OS 率分别为 48%（95%CI 26%-67%）和 35%（95%CI 25%-45%）。共有 48 例患者（41.4%）接受了研究后抗癌药物治疗，最常见的是依托泊苷（20.7%）、卡铂（19.0%）和avelumab（12.1%）。
avelumab 作为 mMCC 患者的一线单药治疗，可带来显著的长期 OS，与一线化疗的历史研究相比具有优势。这些结果进一步支持了 avelumab 作为 mMCC 患者标准治疗的地位。
