医学
内科学
队列
肺炎
肺癌
临床终点
实体瘤疗效评价标准
中期分析
肿瘤科
进行性疾病
胃肠病学
外科
化疗
肺
临床试验
作者
Saiama N. Waqar,Mary W. Redman,Susanne M. Arnold,Fred R. Hirsch,Philip C. Mack,Lawrence H. Schwartz,David R. Gandara,Thomas E. Stinchcombe,Natasha B. Leighl,Suresh S. Ramalingam,Saloni H. Tanna,Ryan S. Raddin,Katherine Minichiello,Jeffrey D. Bradley,Karen Kelly,Roy S. Herbst,Vassiliki A. Papadimitrakopoulou
标识
DOI:10.1016/j.cllc.2020.09.013
摘要
Lung-MAP S1400K was designed to evaluate the response to telisotuzumab vedotin, an antibody-drug conjugate targeting c-MET, in patients with c-MET-positive squamous cell carcinoma (SCC).Patients with previously treated SCC with c-MET-positive tumors (H score ≥ 150, Ventana SP44 assay) were enrolled into 2 cohorts: Cohort 1 (immune checkpoint inhibitor-naive) and Cohort 2 (immune checkpoint inhibitor refractory). Telisotuzumab vedotin 2.7 mg/kg was administered intravenously every 3 weeks until disease progression or unacceptable toxicity. Response assessments were performed every 6 weeks. The primary endpoint was response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints included progression-free survival, overall survival, response within cohort, duration of response, and toxicities. Interim analysis was planned after 20 evaluable patients, with ≥ 3 responses needed to continue enrollment.Forty-nine patients (14% of screened patients) were assigned to S1400K, 28 patients enrolled (15 in Cohort 1 and 13 in Cohort 2), and 23 were eligible. S1400K closed on December 21, 2018 owing to lack of efficacy. Two responses (response rate of 9%; 95% confidence interval, 0%-20%) were reported in cohort 1 (1 complete and 1 unconfirmed partial response), whereas 10 patients had stable disease, with a disease control rate of 52%. The median overall and progression-free survival was 5.6 and 2.4 months, respectively. There were 3 grade 5 events (2 pneumonitis, in Cohort 2, and 1 bronchopulmonary hemorrhage, in Cohort 1).Telisotuzumab vedotin failed to meet the pre-specified response needed to justify continuing enrollment to S1400K. Pneumonitis was an unanticipated toxicity observed in patients with SCC.
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