1413P - Patient-reported outcomes (PROs) from a phase 2 trial of telisotuzumab vedotin (Teliso-V) in c-Met–overexpressing, EGFR wild type, non-squamous non-small cell lung cancer (c-Met OE, EGFR WT, NSq NSCLC)

Background

The phase 2 LUMINOSITY trial (NCT03539536) of Teliso-V monotherapy has shown acceptable safety & promising efficacy in previously treated patients (pts) with c-Met OE, EGFR WT, NSq NSCLC. Interim PRO data are reported.

Methods

Pts received Teliso-V (1.9 mg/kg) Q2W. PROs were assessed using the European Organisation for Research and Treatment of Cancer quality of life (QOL) questionnaires in lung cancer (LC13) & palliative cancer care (C15-PAL). Time to deterioration (TTD) beyond meaningful change threshold (MCT; ≥10 points from baseline) & mean change from baseline (mCFB) were analyzed.

Results

59 pts were evaluated. Median no. of prior therapies was 1 (range 1–3); median follow-up was 81 d. The table shows median TTD. For cough, pain in chest, pain in other parts, & QOL domains where median TTD was not reached, mCFB analyses revealed initial trends toward improvement. Cough, pain in chest, & overall QOL improved beyond MCT in wk 41, 49, & 41, respectively; pain in other parts trended toward deterioration. mCFB analyses revealed trends toward improvement for the LC13 symptom of hemoptysis, and for alopecia, sore mouth. Peripheral neuropathy deteriorated beyond MCT; dysphagia showed no consistent time trend. For C15-PAL, mCFB trend improved for nausea and vomiting, dyspnea (improved beyond MCT in wk 41), pain, fatigue, emotional function, and insomnia over a sustained duration for ≥29 wk, then deteriorated. Appetite loss worsened initially but improved in wk 41. Constipation improved initially then trended toward deterioration in wk 41 & 45.

Conclusions

This interim analysis suggests extended TTD and trends toward improvement from baseline in key lung cancer symptoms, physical functioning, & QOL; and deterioration in peripheral neuropathy. Impact of Teliso-V monotherapy on PROs will also be assessed at LUMINOSITY trial conclusion and in the phase 3, TeliMET NSCLC-01 trial (NCT04928846). Table: 1413P

Time to deterioration in symptoms, functional domains, and QOL

NE, not estimable; NR, Kaplan-Meier curve did not reach 50%.

Clinical trial identification

NCT03539536.

Editorial acknowledgement

Medical writing support was provided by Joanne Franklin, PhD, CMPP, from Aptitude Health, The Hague, the Netherlands, and funded by AbbVie.

Legal entity responsible for the study

AbbVie.

Funding

AbbVie.

Disclosure

S. Lu: Financial Interests, Institutional, Research Grant: AstraZeneca, Hutchmed, Bristol Myers Squibb, Hengrui Medicine, BeiGene, Roche, Hansoh; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Hansoh; Financial Interests, Institutional, Speaker, Consultant, Advisor: AstraZeneca, Pfizer, Hutchmed, Zai Lab, GenomiCare Biotechnology (Shanghai), Yuhan, Menarini, InventisBio Co, Roche; Financial Interests, Institutional, Advisory Board: AstraZeneca, Roche, Mirati Therapeutics. J. Bar: Financial Interests, Institutional, Advisory Board: AbbVie, AstraZeneca, Bayer, BMS, Causalis, Eisai, MSD, Novartis, Roche, Takeda; Financial Interests, Institutional, Research Funding: Immunai, OncoHost, MSD, AstraZeneca. N. Girard: Financial Interests, Institutional, Research Grant: AstraZeneca, Amgen, Boehringer Ingelheim, Eli Lilly, Hoffmann-La Roche, Janssen, Merck, Merck Sharp & Dohme, Novartis, Pfizer, Sivan, Trizell; Financial Interests, Institutional, Speaker, Consultant, Advisor: Bristol Myers Squibb, AstraZeneca, AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Hoffmann-La Roche, Janssen, Merck, Merck Sharp & Dohme, Mirati, Novartis, Pfizer, Roche, Sanofi, Sivan; Financial Interests, Institutional, Other: Roche; Financial Interests, Institutional, Leadership Role: International Thymic Malignancy Interest Group; Financial Interests, Personal, Other: AstraZeneca. Q. Xu, R. Sen, C. Ratajczak, S. Ng, S. Xia: Financial Interests, Institutional, Full or part-time Employment: AbbVie. D.R. Camidge: Financial Interests, Institutional, Speaker, Consultant, Advisor: AbbVie, Amgen, Astellas BioPharma, AnHeart Therapeutics, Apollomics, AstraZeneca, BeiGene, Bio-Thera, Blueprint Medicines, Bristol Myers Squibb, Daiichi Sankyo, Eisai, Elevation Oncology, EMD Serono, GSK, Helsinn Therapeutics, Hengrui Pharmaceutical, Janssen, Kestrel Labs, Lilly, Mersana, Nuvalent, Inc., OnKure, Pfizer, Puma Biotechnology, Qilu Pharmaceutical, Ribon Therapeutics, Roche, Sanofi, Seattle Genetics, Takeda, Turning Point Therapeutics; Financial Interests, Institutional, Research Funding: Inivata (Inst).