600TiP - Phase III study of telisotuzumab vedotin (Teliso-V) vs docetaxel in pretreated c-Met overexpressing EGFR wildtype (WT) non-squamous (NSQ) locally advanced/metastatic non-small cell lung cancer (a/mNSCLC)

Background

c-Met (MET protein) is overexpressed (OE) in ∼25% of patients (pts) with EGFR WT NSQ NSCLC (Ansell. CRUK 2022). In the phase 2 LUMINOSITY study (NCT03539536), Teliso-V, a c-Met–directed antibody-drug conjugate, had an overall response rate of 52% in c-MET high OE pts (37% in all [intermediate + high OE] pts) with previously treated EGFR WT NSQ NSCLC with an acceptable safety profile; ORR was 86% in a subanalysis of Asian pts with high c-MET OE (58% in all pts) (Horinouchi. JSMO 2023). Teliso-V warrants further investigation, including in Asian pts.

Trial design

TeliMET NSCLC-01 (NCT04928846) is a global, open-label, randomized phase 3 trial evaluating if Teliso-V has better efficacy vs current standard of care (docetaxel) in pts with c-Met OE (central lab testing using VENTANA MET [SP44] RxDx Assay [Investigational Use Only (IUO) device], Ventana Medical Systems), EGFR WT, NSQ, a/mNSCLC. Key eligibility criteria include aged ≥18 and ECOG performance status 0–1. Pts must have progressed on at least 1 prior line of therapy for a/mNSCLC, which includes no more than 1 line of prior platinum-containing systemic chemotherapy and must be c-Met antibody and docetaxel naive. Pts will be randomized 1:1 to receive Teliso-V (1.9 mg/kg Q2W) or docetaxel (75 mg/m² Q3W) monotherapy until disease progression/met study discontinuation criteria. The co-primary endpoints are progression-free survival (per independent central review [ICR]) and overall survival. Secondary endpoints include objective response rate, duration of response (both per ICR), and pt-reported outcomes. Safety and tolerability assessments include adverse events (AEs), and drug discontinuation/dose modifications due to AEs. Pharmacokinetic parameters as well as biomarkers and their correlation to clinical responses will be assessed. Subgroup analysis will be conducted for Asian pts. Enrollment of ≥698 pts is planned across ∼300 sites in ∼40 countries. As of 4 July 2023, 162 sites are actively recruiting in 26 countries including Asia-Pacific countries (China [25 sites], Japan [38 sites], South Korea [5 sites], Taiwan [8 sites], Australia [2 sites]).

Clinical trial identification

NCT04928846.

Legal entity responsible for the study

AbbVie.

Funding

AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the abstract. No honoraria or payments were made for authorship.

Disclosure

J. Tanizaki: Financial Interests, Personal, Invited Speaker: AstraZeneca K.K., Boehringer Ingelheim Japan Inc, Bristol Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Eli Lilly Japan K.K., Janssen Pharmaceutical K.K., MSD K.K, Nihon Medi-Physics Co. Ltd., Nippon Kayaku Co. Ltd., Taiho; Financial Interests, Personal, Advisory Role: Boehringer Ingelheim Japan. H. Akamatsu: Financial Interests, Personal, Other, Lecturer: MSD KK, Eli Lilly Japan KK, Amgen Inc Lecture, Chugai Pharmaceutical Co Ltd, Ono Pharmaceutical Co Ltd, AstraZeneca KK, Boehringer Ingelheim Japan Inc, Bristol Myers Squibb Co Ltd, Novartis Pharma KK, Taiho Pharmaceutical Co Ltd, Pfizer Japan Inc, Nippon ; Financial Interests, Personal, Research Grant: MSD KK, Eli Lilly Japan KK, and Amgen Inc. J. Su: Financial Interests, Personal, Invited Speaker: AstraZeneca, Taiwan, Boehringer Ingelheim, Taiwan, Chugai Pharmaceutical Co., Taiwan, MSD, Taiwan, F. Hoffmann-La Roche, Taiwan, Ono Pharmaceutical, Taiwan, Pfizer, Taiwan. M.S. Xia, B. Ainsworth, M. Li, E. Bolotin, J. Seraj: Financial Interests, Personal, Stocks/Shares: AbbVie Inc. S. Lu: Financial Interests, Personal, Research Funding: AstraZeneca, Hutchison MediPharma, BMS, Hengrui Therapeutics, BeiGene, Roche, Hansoh; Financial Interests, Personal, Other, Speaker fees: AstraZeneca, Roche, Hansoh, Hengrui Therapeutics; Financial Interests, Personal, Advisory Role: AstraZeneca, Pfizer, Boehringer Ingelheim, Hutchison MediPharma, Simcere, Zai Lab, GenomiCare, Yuhan Corporation, prIME Oncology, Menarini, Roche. All other authors have declared no conflicts of interest.