Patient-reported outcomes with acasunlimab monotherapy and in combination with pembrolizumab: Results from a phase II study of PD-L1+ mNSCLC

Document Type

Conference Proceeding

Publication Date

4-1-2026

Publication Title

ESMO Open

Keywords

acasunlimab, pembrolizumab, programmed death 1 ligand 1, adult, aged, clinical trial, conference abstract, controlled study, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, female, human, ivy, lung cancer, major clinical study, male, mesothelioma, middle aged, monotherapy, parttime employment, patient-reported outcome, phase 2 clinical trial, quality of life

Abstract

Background: Acasunlimab (ACA, DuoBody®-PD-L1x4-1BB) monotherapy and in combination with pembrolizumab (PEM; Q3W/Q6W) was evaluated in a Ph 2 trial of patients (pts) with PD-L1+ mNSCLC who progressed after ≥1 prior SOC treatment including PD-L1 inhibitors (NCT05117242). ACA+PEM Q6W showed promising OS, durable benefit, and a manageable safety profile. Exploratory analyses were conducted to assess patient-reported outcomes (PROs) and HRQoL from primary analysis of the Ph 2 trial at data cutoff (12/02/2024). Methods: Pts received ACA (Arm A: 100mg Q3W×2 → 500mg Q6W) or ACA+PEM (Arm B: 100mg+PEM 200mg Q3W; Arm C: 100mg+PEM 400mg Q6W). Mean change from baseline (BL) in global HRQoL, functioning, symptoms, and time to true deterioration (TTD) were assessed through EORTC QLQ-C30 and QLQ-LC13. Pts with available PROs at BL and ≥1 post-BL assessment were included in the analysis. Results: PRO compliance at BL was acceptable (∼ 80% across arms) and gradually declined over time. At wk 12, mean change from BL showed global HRQoL was stable in Arm C, with numerical declines in Arm A/B (Table). Across other functional domains (physical, role, emotional, cognitive, social), scores in Arm C were stable within ±10-point threshold; Arm A/B showed greater numerical declines (data not shown). Median TTD (month [95% CI]) was numerically longest in Arm C across all domains (FAS), with global HRQoL scale duration of 2.6 (0.5, 2.8) in Arm A, 2.8 (1.4, 3.9) in Arm B, and 6.7 (2.4, NR) in Arm C. Mean symptom scores in Arm C improved slightly from BL compared with Arm A/B (Table). Exploratory PROs indicated preserved HRQoL with Q6W regimen. Together with OS and safety results in the FAS (N=61), these findings add context to the clinical activity of the combination. [Formula presented] Conclusions: The PRO results corroborate the clinical findings demonstrating that the Q6W combination regimen (ACA + PEM, Arm C) showed more favorable outcomes compared with the Q3W combination regimen (Arm B) and ACA monotherapy (Arm A). Clinical trial identification: NCT05117242. Editorial acknowledgement: Medical writing and editorial support was provided by employees of Cadent Medical Communications, a division of Syneos Health, and funded by Genmab A/S. Legal entity responsible for the study: Genmab A/S. Funding: Genmab A/S. Disclosure: J.G. Aerts: Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: MSD, CureVac, nutricia; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Other, Inventor/medical advisor: Amphera; Financial Interests, Personal, Stocks/Shares, value is undetermined: Amphera; Financial Interests, Institutional, Invited Speaker: Pamgene, Eli Lilly, BMS, Novartis, Verastem, AstraZeneca, MSD; Financial Interests, Institutional, Royalties, and personal if granted: Amphera; Financial Interests, Institutional, Funding: Nutricia/Danone; Non-Financial Interests, Personal, Member of Board of Directors: Int Ass for the study of Lung Cancer (AISLC, Int Mesothelioma Interest Group; Non-Financial Interests, Personal, Leadership Role, treasurer: IASLC; Non-Financial Interests, Personal, Leadership Role, board member: IMIG. B. Besse: Financial Interests, Personal, Funding: AbbVie, Amgen, AstraZeneca, Chugai Pharmaceutical, Daiichi Sankyo, Ellipse Pharma, EISAI, Genmab, Genzyme Corporation, Hedera Dx, Inivata, Ipsen, Janssen, MSD, PharmaMar, Roche-Genentech, Sanofi, Socar Research, Tahio Oncology, Turning Point Therapeutics. W. Theelen: Financial Interests, Institutional, Funding: AstraZeneca, MSD, Regeneron. D.M. Kowalski: Financial Interests, Personal, Advisory Board: Roche, Boehringer Ingelheim, Novartis, Bristol Myers Squibb, MSD, Sanofi-Aventis, Takeda, Pfizer, Johnson & Johnson. Y. Zhou, M. Holst Mørch, A. Chekalova, V. Joish: Financial Interests, Personal, Full or part-time Employment: Genmab. M.J. Chisamore: Financial Interests, Institutional, Full or part-time Employment: Merck & Co. Inc; Financial Interests, Institutional, Stocks/Shares: erck & Co. Inc. All other authors have declared no conflicts of interest.

Volume

11

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