Abstract 1313P
Background
The c-Met (MET protein)-directed antibody-drug conjugate Teliso-V showed promising efficacy and manageable safety as monotherapy in pts with c-Met protein OE, EGFR wildtype, NSQ NSCLC in the phase 2 LUMINOSITY trial (NCT03539536). Exploratory PRO data from LUMINOSITY are presented here.
Methods
Pts were treated with 1.9 mg/kg Teliso-V Q2W. Lung cancer/treatment-related symptoms and impact on function and quality of life (QOL) were evaluated using the EORTC QOL questionnaires in lung cancer (LC13), palliative cancer care (C15-PAL), and peripheral neuropathy (CIPN20). Mean change from baseline (mCFB) and time to deterioration (TTD; beyond a threshold of ≥10 points from baseline) analyses were conducted and stratified by c-Met protein OE level and response status.
Results
Data from 161 pts were evaluated, 78 with c-Met high OE and 83 with c-Met intermediate OE. Median follow-up was ∼5.6 mo. PRO completion rates remained ≥80% through C25D1. Overall, mCFB analyses showed improvement for cough and pain in chest, deterioration for peripheral neuropathy (PN) and sensory and motor symptoms (SaMS), and maintenance for QOL. A trend toward improvement was seen for pain in other parts and alopecia in the c-Met high OE group. Median TTD are listed in the table. Among all pts, those with disease control (≥SD for ≥12 wk; n=95) had delayed deterioration in QOL (p=0.019), dyspnea (p=0.0019), and physical functioning (p=0.0007) vs those without (n=66). Responders (≥PR; n=46) had delayed deterioration in QOL (p=0.044) vs nonresponders (n=115). Table: 1313P
TTD
Median, mo (95% CI) | ||||
c-Met intn=83 | c-Met highn=78 | Total N=161 | ||
LC13 | Cough | NR (6.7, NE) | 8.3 (2.9, NE) | 11.5 (6.7, NE) |
Pain in chest | 12.0 (8.6, NE) | NR (4.6, NE) | NR (11.5, NE) | |
Pain in arm/shoulder | 13.8 (6.3, NE) | 11.3 (3.8, NE) | 11.3 (6.3, NE) | |
Pain in other parts | 6.5 (5.1, NE) | 15.3 (2.8, NE) | 6.8 (5.1, NE) | |
Dyspnea | 3.6 (1.9, 7.7) | 4.1 (1.9, 6.9) | 3.8 (2.0, 6.3) | |
Peripheral neuropathy | 3.7 (1.9, 5.6) | 4.6 (2.8, 10.6) | 3.8 (2.8, 5.6) | |
C15-PAL | Physical functioning | 4.6 (2.4, 6.6) | 6.5 (2.8, 10.0) | 4.7 (3.1, 7.5) |
QOL | 3.4 (2.1, 8.3) | 4.6 (1.9, 12.5) | 4.4 (2.4, 8.3) | |
Pain | 3.8 (1.9, 6.0) | 6.4 (4.1, 11.3) | 5.1 (2.8, 6.4) | |
CIPN20 | Sensory symptoms | 5.1 (3.7, 7.5) | 4.6 (3.5, 8.2) | 4.7 (3.8, 6.5) |
Motor symptoms | 6.7 (5.1, 8.3) | 6.5 (4.6, 8.8) | 6.6 (5.6, 7.7) |
Conclusions
Pts treated with Teliso-V reported improvement or maintenance in most PROs evaluated, with extended TTD in key symptoms, physical functioning, and QOL; deterioration was observed in PN and SaMS. The ongoing phase 3 TeliMET NSCLC-01 trial (NCT04928846) will further assess PROs to confirm trends observed in LUMINOSITY.
Clinical trial identification
NCT03539536.
Editorial acknowledgement
Medical writing support was provided by Judith Land, PhD, CMPP, from Aptitude Health, The Hague, the Netherlands, and funded by AbbVie.
Legal entity responsible for the study
AbbVie Inc.
Funding
AbbVie Inc.
Disclosure
N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi, Gilead; Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer, Novartis, Sanofi, AbbVie, Amgen, Lilly, Grunenthal, Takeda, Owkin, Leo Pharma, Daiichi Sankyo, Ipsen; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS, Leo Pharma; Financial Interests, Institutional, Research Grant: MSD; Other, Family member is an employee: AstraZeneca. S. Lu: Financial Interests, Institutional, Research Grant: AstraZeneca, HUTCHMED, Bristol Myers Squibb, Hengrui Medicine, BeiGene, Roche, and Hansoh; Financial Interests, Personal, Financially compensated role, Honoraria: AstraZeneca and Hansoh; Financial Interests, Personal, Advisory Role, Advisor or Consultant: AstraZeneca, Pfizer, HUTCHMED, Zai Lab, GenomiCare Biotechnology (Shanghai), Yuhan, Menarini, InventisBio Co., and Roche; Financial Interests, Personal, Advisory Board, Data safety monitoring board or advisory board participation: AstraZeneca, Roche, and Mirati Therapeutics. J. Bar: Financial Interests, Personal, Advisory Board: MSD, Takeda, Roche, Pfizer, AbbVie, Bayer, AstraZeneca, Merck-Serono, J-C healthcare, Medison Pharma, Amgen; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Other, Steering committee: AbbVie, Merck Healthcare KGaA, Roche, AstraZeneca; Financial Interests, Institutional, Local PI: MSD, Roche, Takeda, AbbVie; Financial Interests, Institutional, Other, local sub-investigator: Novartis; Financial Interests, Institutional, Research Grant: OncoHost, ImmuneAI, AstraZeneca; Non-Financial Interests, Other, Committee member: IASLC. Q. Xu, S. Ng, R. Sen, Z. Majd, I. Nsiah, C. Ratajczak, M.S. Xia, S. Karve: Financial Interests, Personal, Full or part-time Employment: AbbVie Inc.; Financial Interests, Personal, Stocks/Shares: AbbVie Inc. D.R. Camidge: Financial Interests, Personal, Financially compensated role, Honoraria: AbbVie, Amgen, Astellas Pharma, AnHeart Therapeutics, Appolomics, AstraZeneca, BeiGene, Bio-Thera Solutions, Blueprint Medicines, Bristol Myers Squibb, Daiichi Sankyo, Eisai, Elevation Oncology, EMD Serono, GSK, Helsinn Therapeutics, Hengrui Pharmaceuticals, Janssen, Kestrel Labs, Lilly, Mersana, Nuvalent, OnKure, Pfizer, Puma Biotechnology, Qilu Pharmaceutical, Ribon Therapeutics, Roche, Sanofi, Seagen, Takeda, Turning Point Therapeutics; Financial Interests, Institutional, Research Funding: Inivata.
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