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

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. 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. 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: 1530PZolbetuximab + chemo LSM (standard error [SE])Placebo + chemo LSM (SE)Zolbetuximab vs placebo arms LSM (95% CI)P valueSPOTLIGHT Cycle 9 Day 1(N = 283)(N = 282)GHS/QoL1.65 (1.60)4.20 (1.77)-2.54 (-7.02, 1.93)0.263PF-5.68 (1.77)0.34 (1.88)-6.02 (-10.85, -1.19)0.015Pain-6.85 (1.86)-9.12 (2.08)2.27 (-2.97, 7.51)0.394N/V-3.38 (1.64)-2.31 (1.80)-1.07 (-5.61, 3.47)0.642GLOW Cycle 17 Day1(N = 254)(N = 253)GHS/QoL-0.04 (2.43)-5.55 (2.89)5.51 (-1.82, 12.84)0.139PF-2.05 (1.88)-2.93 (2.19)0.88 (-4.67, 6.43)0.753Pain-5.39 (2.32)-7.27 (2.88)1.88 (-5.30, 9.07)0.604N/V-0.95 (1.89)2.85 (2.31)-3.79 (-9.57, 1.98)0.192 Open table in a new tab 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.