%0 Journal Article
%T A Phase 1b Study of Telisotuzumab Vedotin in Combination With Nivolumab in Patients With NSCLC.
%A Camidge DR
%A Barlesi F
%A Goldman JW
%A Morgensztern D
%A Heist R
%A Vokes E
%A Angevin E
%A Hong DS
%A Rybkin II
%A Barve M
%A Bauer TM
%A Delmonte A
%A Dunbar M
%A Motwani M
%A Parikh A
%A Noon E
%A Wu J
%A Blot V
%A Kelly K
%J JTO Clin Res Rep
%V 3
%N 1
%D Jan 2022
%M 35005654
暂无%R 10.1016/j.jtocrr.2021.100262
%X <B>BACKGROUND: </B>Telisotuzumab vedotin (Teliso-V) is an anti-c-Met-directed antibody-drug conjugate that has exhibited antitumor activity as monotherapy in NSCLC. Its potential activity combined with programmed cell death protein-1 inhibitors has not been previously evaluated.<BR><B>METHODS: </B>In a phase 1b study (NCT02099058), adult patients (≥18 y) with advanced NSCLC received combination therapy with Teliso-V (1.6, 1.9, or 2.2 mg/kg, every 2 wk) plus nivolumab (3 mg/kg, 240 mg, or per locally approved label). The primary objective was to assess safety and tolerability; secondary objectives included the evaluation of antitumor activity.<BR><B>RESULTS: </B>As of January 2020, a total of 37 patients received treatment with Teliso-V (safety population) in combination with nivolumab; 27 patients (efficacy population) were c-Met immunohistochemistry-positive. Programmed death-ligand 1 (PD-L1) status was evaluated in the efficacy population (PD-L1-positive [PD-L1+]: n = 15; PD-L1-negative [PD-L1-]: n = 9; PD-L1-unknown: n = 3). The median age was 67 years and 74% (20 of 27) of patients were naive to immune checkpoint inhibitors. The most common any-grade treatment-related adverse events were fatigue (27%) and peripheral sensory neuropathy (19%). The pharmacokinetic profile of Teliso-V plus nivolumab was similar to Teliso-V monotherapy. The objective response rate was 7.4%, with two patients (PD-L1+, c-Met immunohistochemistry H-score 190, n = 1; PD-L1-, c-Met H-score 290, n = 1) having a confirmed partial response. Overall median progression-free survival was 7.2 months (PD-L1+: 7.2 mo; PD-L1-: 4.5 mo; PD-L1-unknown: not reached).<BR><B>CONCLUSIONS: </B>Combination therapy with Teliso-V plus nivolumab was well tolerated in patients with c-Met+ NSCLC with limited antitumor activity.