A Phase 1b Study of Telisotuzumab Vedotin in Combination With Nivolumab in Patients With NSCLC

D. Ross Camidge, Fabrice Barlesi, Jonathan W. Goldman, Daniel Morgensztern, Rebecca Heist, Everett Vokes, Eric Angevin, David S. Hong, Igor I. Rybkin, Minal Barve, Todd M. Bauer, Angelo Delmonte, Martin Dunbar, Monica Motwani, Apurvasena Parikh, Elysa Noon, Jun Wu, Vincent Blot, Karen Kelly

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1 Scopus citations

Abstract

Introduction: 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. Methods: 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. Results: 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). Conclusions: Combination therapy with Teliso-V plus nivolumab was well tolerated in patients with c-Met+ NSCLC with limited antitumor activity.

Original languageEnglish
Article number100262
JournalJTO Clinical and Research Reports
Volume3
Issue number1
DOIs
StatePublished - Jan 2022

Keywords

  • Antibody-drug conjugate
  • Nivolumab
  • Non–small cell lung cancer
  • Telisotuzumab vedotin
  • c-Met

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