O10-2 Telisotuzumab vedotin monotherapy in Asian patients with c-Met–overexpressing advanced non-small cell lung cancer

Telisotuzumab vedotin (Teliso-V) is an antibody-drug conjugate composed of a c-Met antibody (ABT-700) and the microtubule inhibitor monomethyl auristatin E. The phase 2 LUMINOSITY trial (NCT03539536) aims to identify the c-Met protein overexpressing (OE) non-small cell lung cancer (NSCLC) populations best suited to Teliso-V (Stage 1) and expand select groups for further evaluation of efficacy (Stage 2). The c-Met OE non-squamous (NSQ) epidermal growth factor receptor (EGFR) wildtype (WT) cohort is currently expanding in Stage 2. Data from the fourth interim analysis are presented, including data for the subgroup of Asian patients (pts). Pts had locally advanced/metastatic NSCLC, ≤2 prior lines of systemic therapy, ≤1 line of chemotherapy, and tumors that were c-Met OE by central immunohistochemistry (IHC; Ventana, Tucson, AZ). c-Met OE was defined for the NSQ cohort as ≥25% 3+ by IHC (high, ≥50% 3+; intermediate [Int], 25 to <50% 3+). Teliso-V was dosed at 1.9 mg/kg IV every 2 weeks. Primary endpoint is objective response rate (ORR) by independent central review. As of data cutoff (27 May 2021), 136 pts received Teliso-V; 122 were evaluable for ORR. Among 52 evaluable pts in the NSQ EGFR WT cohort, ORR was 36.5% (52.2% [12/23], c-Met high; 24.1% [7/29], c-Met Int). Thirty-nine Asian pts received Teliso-V; 36 were evaluable for ORR. Among 12 evaluable NSQ EGFR WT Asian pts, ORR was 58% (86% [6/7], c-Met high). The most common any-grade adverse events (AEs) among all dosed pts (N=136) were peripheral sensory neuropathy (25.0%), nausea (22.1%), and hypoalbuminemia (20.6%). Among all dosed Asian pts (n=39), most common AEs were vision blurred (30.8%), peripheral sensory neuropathy (23.1%), and hypoalbuminemia (20.5%). Teliso-V demonstrated promising efficacy in pts with previously treated c-Met OE NSQ EGFR WT NSCLC, including in Asian pts. The safety profile observed in all dosed pts was consistent with the third interim analysis.