Nicolas Girard, Jonathan Goldman, Shun Lu, Jair Bar, Hidehito Horinouchi, Nathalie Daaboul, Chunling Liu, İrfan Çiçin, Nuran Katgı, Alona Zer, Tudor Ciuleanu, Niels Reinmuth, David Planchard, Se-Hoon Lee, Aaron S. Mansfield, Mor Moskovitz, Shobhit Baijal, Christina S. Baik, John Hrom, Rebecca S. Heist, Ozan Yazici, Mukesh Verma, Deise Uema, Shilpen Patel, Summer Xia, Christine K. Ratajczak, D. Ross Camidge
Introduction: wild-type, nonsquamous NSCLC. We present updated outcomes with approximately 6 months longer follow-up and explore the impact of previous therapies. Methods: Patients (≥18 y; had previous therapy including ≤1 chemotherapy) received 1.9 mg/kg Teliso-V every 2 weeks. c-Met protein overexpression (clinical trial assay for MET [SP44] [Roche]) was defined as greater than or equal to 25% tumor cells with 3+ staining intensity (c-Met high: ≥50% 3+; c-Met intermediate: 25 to <50% 3+). Primary end point was the overall response rate by independent central review per the Response Evaluation Criteria in Solid Tumors version 1.1. Results: As of February 21, 2024, 172 patients received at least one dose of Teliso-V; 168 patients (c-Met high, n = 84; c-Met intermediate, n = 84) were evaluable for efficacy. The overall response rate was 29.2% (95% confidence interval [CI]: 22.4-36.7; c-Met high, 34.5% [24.5-45.7]; c-Met intermediate, 23.8% [15.2-34.3]). Median duration of response was 7.2 months (95% CI: 5.5-11.0; c-Met high, 7.2 [95% CI: 4.2-12.0]; c-Met intermediate, 7.2 [95% CI: 4.7-11.5]). Previous therapy (platinum, immune checkpoint inhibitors, or both) did not impact efficacy outcomes. The most common treatment-related adverse event was peripheral sensory neuropathy (any-grade: 31%; grade ≥3: 7%). Conclusions: wild-type, nonsquamous NSCLC. ClinicalTrialsgov ID number: NCT03539536.