*April 2021*
Single-agent telisotuzumab vedotin (teliso-v; ABBV-399) induced an encouraging objective response rate (ORR) with a tolerable safety profile in patients with previously treated non–small cell lung cancer (NSCLC) who were c-MET positive, according to data from a phase 2 study (NCT03539536) presented in a virtual poster during the AACR Annual Meeting 2021. The study explored the safety and efficacy of teliso-v, an anti-c-Met antibody conjugated with a tubulin inhibitor MMAE, in previously treated patients with c-Met–positive advanced NSCLC.
The ongoing phase 2 study is expecting to enroll about 233 patients across 2 stages and has an estimated completion date of January 2025. During the open-label, single-arm study, patients received teliso-v at 1.9 mg/kg intravenously every 14 days. Patients with nonsquamous histology were separated into cohorts by EGFR mutations and then into subgroups based on level of c-Mt expression; intermediate c-Met was defined as staining on ≥25% to <50% of tumor cells at 3+ intensity, and high c-Met was considered ≥50% staining at 3+ intensity. For patients with squamous histology, c-Met positivity was defined as staining on ≥75% of tumor cells at 1+ intensity.
The primary outcome of the study was ORR with a time frame of up to approximately 3 years. Secondary outcomes included duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
