A Phase II Study of Telisotuzumab Vedotin in Patients With c-MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753).

摘要: Abstract Introduction Lung-MAP S1400K was designed to evaluate the response telisotuzumab vedotin, an antibody-drug conjugate targeting c-MET, in patients with c-MET–positive squamous cell carcinoma (SCC). Patients and Methods previously treated SCC tumors (H score ≥ 150, Ventana SP44 assay) were enrolled into 2 cohorts: Cohort 1 (immune checkpoint inhibitor-naive) inhibitor refractory). Telisotuzumab vedotin 2.7 mg/kg administered intravenously every 3 weeks until disease progression or unacceptable toxicity. Response assessments performed 6 weeks. The primary endpoint by Evaluation Criteria Solid Tumors (RECIST) v1.1. Secondary endpoints included progression-free survival, overall within cohort, duration of response, toxicities. Interim analysis planned after 20 evaluable patients, with ≥ responses needed continue enrollment. Results Forty-nine (14% screened patients) assigned S1400K, 28 (15 13 2), 23 eligible. closed on December 21, 2018 owing lack efficacy. Two (response rate 9%; 95% confidence interval, 0%-20%) reported cohort (1 complete unconfirmed partial response), whereas 10 had stable disease, a control 52%. median survival 5.6 2.4 months, respectively. There grade 5 events (2 pneumonitis, 2, bronchopulmonary hemorrhage, 1). Conclusion failed meet pre-specified justify continuing enrollment S1400K. Pneumonitis unanticipated toxicity observed SCC.