1530P - Health-related quality of life (hrqol) in patients with claudin-18 isoform 2-positive (CLDN18.2+) locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mg/GEJ) adenocarcinoma: Results from SPOTLIGHT and GLOW

Background

In the randomized, double-blind, global SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials, first-line zolbetuximab + chemo (mFOLFOX6 [SPOTLIGHT]; CAPOX [GLOW]) showed improved PFS (SPOTLIGHT, HR 0.75 [95% CI 0.60, 0.94], P = 0.0066; GLOW, HR 0.69 [95% CI 0.54, 0.87], P = 0.0007) and OS (SPOTLIGHT, HR 0.75 [95% CI 0.60, 0.94], P = 0.0053; GLOW, HR 0.77 [95% CI 0.62, 0.97], P = 0.0118) compared with placebo + chemo in patients with CLDN18.2+, HER2−, LA unresectable or mG/GEJ adenocarcinoma at data cutoff. We present key patient-reported outcome (PRO) findings from these trials.

Methods

Patients completed the EORTC QLQ-C30 and QLQ-OG25 at screening, every 3 weeks on treatment, at discontinuation, and 30 and 90 days thereafter. Changes in scores from baseline, time to confirmed deterioration (TTCD), and time to definitive deterioration (TTDD) in PROs based on literature thresholds were evaluated. Least square mean (LSM) changes from baseline were summarized descriptively. TTCD and TTDD were assessed by Kaplan-Meier estimates and Cox hazard models.

Results

Table describes the LSM changes from baseline for SPOTLIGHT (N = 565) and GLOW (N = 507). No clinically meaningful deteriorations in global health status and quality of life (GHS/QoL), physical functioning (PF), abdominal pain and discomfort, or nausea/vomiting (N/V) were observed. Overall TTCD and TTDD results were similar between arms in both studies.

Table: 1530P

Conclusions

There were not overall clinical HRQoL differences between patients in the zolbetuximab and placebo arms. Zolbetuximab + chemo improved clinical outcomes without negatively affecting HRQoL in key PROs in both SPOTLIGHT and GLOW.

Clinical trial identification

NCT03653507.

Editorial acknowledgement

Medical writing support, conducted in accordance with Good Publication Practice (GPP 2022) and the International Committee of Medical Journal Editors (ICMJE) guidelines, was provided by Ann Ferguson, PhD, of Oxford PharmaGenesis Inc., and was funded by Astellas Pharma Inc.

Legal entity responsible for the study

Astellas Pharma Inc.

Funding

Astellas Pharma Inc.

Disclosure

F. Lordick: Financial Interests, Personal, Advisory Board: Amgen, Astellas, BMS, Bayer, BeiGene, Biontech, Eli Lilly, Elsevier, MSD, Novartis, Roche, Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Eli Lilly, Imedex, Incyte, MSD, MedUpdate, Medscape, Merck, Roche, Servier, StreamedUp!, Daiichi Sankyo, Novartis, Art Tempi; Financial Interests, Personal, Writing Engagement: Deutscher Ärzteverlag, Iomedico, Springer-Nature; Financial Interests, Institutional, Research Grant: BMS, Gilead. E. Van Cutsem: Financial Interests, Personal, Advisory Board: AbbVie, ALX, Amgen, Array, Astellas, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, GSK, Incyte, Ipsen, Lilly, Merck Sharp & Dohme, Merck KGaA, Mirati, Novartis, Nordic, Pierre Fabre, Pfizer, Roche, Seattle Genetics, Servier, Takeda, Terumo, Taiho, Zymeworks; Financial Interests, Institutional, Research Grant: Amgen, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Ipsen, Lilly, Merck Sharp & Dohme, Merck KGaA, Novartis, Roche, Servier. K. Shitara: Financial Interests, Personal, Advisory Board: Lilly, Bristol Myers Squibb, Takeda, Pfizer, Ono Pharmaceutical, MSD, Taiho, Novartis, AbbVie, GSK, Daiichi Sankyo, Amgen, Boehringer Ingelheim, Guardant Health Japan Corp, Astellas Pharma Inc.; Financial Interests, Personal, Invited Speaker: Janssen Pharmaceutical K.K.; Financial Interests, Institutional, Research Grant: Astellas, Ono Pharmaceutical, Daiichi Sankyo, Taiho, Chugai Pharmaceutical, MSD, Eisai, Amgen. R. Xu: Financial Interests, Personal, Invited Speaker: BMS, MSD; Financial Interests, Personal, Advisory Board: Henrui, BeiGene, Astellas, Merck, Junshi. J.A. Ajani: Financial Interests, Personal, Research Funding: Astellas Pharma Inc.; Financial Interests, Research Funding: Turning Point Therapeutics, Inc., Bristol Myers Squibb, Merck, Taiho Pharmaceutical, Delta-Fly Pharma, Inc., Roche, ProLynx Inc, Zymeworks; Financial Interests, Research Grant: Daiichi Sankyo, Leap Therapeutics, Inc., Gilead Sciences, Inc., Lanova Pharma; Financial Interests, Speaker, Consultant, Advisor: Bristol Myers Squibb, Merck, Astellas Pharma Inc., Amgen, Taiho Pharmaceutical, Zymeworks, BeiGene, AstraZeneca, Daiichi Sankyo, Bayer, GRAIL, Novartis, Geneos, Servier Laboratories, Gilead Sciences, Inc.; Financial Interests, Other, receiving support for travel and/or meeting attendance: Daiichi Sankyo, Bristol Myers Squibb, Merck, BeiGene. M.A. Shah: Financial Interests, Personal, Research Funding: Astellas Pharma Inc., Merck, Bristol Myers Squibb, Oncolys BioPharma; Financial Interests, Personal, Leadership Role: ASCO Leadership Council. M. Oh; A. Ganguli; P. Bhattacharya; M. Matsangou; J.W. Park: Financial Interests, Personal, Full or part-time Employment: Astellas Pharma Global Development, Inc. S. Rhoten: Financial Interests, Personal, Full or part-time Employment: IQVIA. Y. Kang: Financial Interests, Personal, Advisory Board: ALX Oncology, Zymeworks, Amgen, Novartis, MacroGenics, Daehwa, Blueprint, Surface Oncology, BMS, Merck, Roche, LISCure.