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Camidge, D. Ross; Barlesi, Fabrice; Goldman, Jonathan W.; Morgensztern, Daniel; Heist, Rebecca; Vokes, Everett; Spira, Alex; Angevin, Eric; Su, Wu-Chou; Hong, David S.; Strickler, John H.; Motwani, Monica; Dunbar, Martin; Parikh, Apurvasena; Noon, Elysa; Blot, Vincent; Wu, Jun; Kelly, Karen

Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein–Expressing Non–Small-Cell Lung Cancer

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  • Medientyp: E-Artikel
  • Titel: Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein–Expressing Non–Small-Cell Lung Cancer
  • Beteiligte: Camidge, D. Ross; Barlesi, Fabrice; Goldman, Jonathan W.; Morgensztern, Daniel; Heist, Rebecca; Vokes, Everett; Spira, Alex; Angevin, Eric; Su, Wu-Chou; Hong, David S.; Strickler, John H.; Motwani, Monica; Dunbar, Martin; Parikh, Apurvasena; Noon, Elysa; Blot, Vincent; Wu, Jun; Kelly, Karen
  • Erschienen: American Society of Clinical Oncology (ASCO), 2023
  • Erschienen in: Journal of Clinical Oncology, 41 (2023) 5, Seite 1105-1115
  • Sprache: Englisch
  • DOI: 10.1200/jco.22.00739
  • ISSN: 0732-183X; 1527-7755
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: PURPOSE Overexpression of c-Met protein and epidermal growth factor receptor ( EGFR) mutations can co-occur in non–small-cell lung cancer (NSCLC), providing strong rationale for dual targeting. Telisotuzumab vedotin (Teliso-V), a first-in-class antibody-drug conjugate targeting c-Met, has shown a tolerable safety profile and antitumor activity as monotherapy. Herein, we report the results of a phase Ib study (ClinicalTrials.gov identifier: NCT02099058 ) evaluating Teliso-V plus erlotinib, an EGFR tyrosine kinase inhibitor (TKI), in patients with c-Met–positive (+) NSCLC. PATIENTS AND METHODS This study evaluated Teliso-V (2.7 mg/kg once every 21 days) plus erlotinib (150 mg once daily) in adult patients (age ≥ 18 years) with c-Met+ NSCLC. Later enrollment required presence of an EGFR-activating mutation ( EGFR-M +) and progression on a prior EGFR TKI. End points included safety, pharmacokinetics, objective response rate (ORR), and progression-free survival (PFS). The efficacy-evaluable population consisted of c-Met+ patients (confirmed histology [H]-score ≥ 150) who had at least one postbaseline scan; c-Met+ patients with H-scores ≥ 225 were classified as c-Met high. RESULTS As of January 2020, 42 patients were enrolled (N = 36 efficacy-evaluable). Neuropathies were the most common any-grade adverse events reported, with 24 of 42 patients (57%) experiencing at least one event. The pharmacokinetic profile of Teliso-V plus erlotinib was similar to Teliso-V monotherapy. Median PFS for all efficacy-evaluable patients was 5.9 months (95% CI, 2.8 to not reached). ORR for EGFR-M + patients (n = 28) was 32.1%. Of EGFR-M + patients, those who were c-Met high (n = 15) had an ORR of 52.6%. Median PFS was 6.8 months for non-T790M+ and for those whose T790M status was unknown, versus 3.7 months for T790M+. CONCLUSION Teliso-V plus erlotinib showed encouraging antitumor activity and acceptable toxicity in EGFR TKI-pretreated patients with EGFR-M+, c-Met+ NSCLC.
  • Zugangsstatus: Freier Zugang