OncLive® On Air S11 Ep35: FDA Approval Insights: Zolbetuximab for CLDN18.2+ HER2-Negative Gastric and GEJ Adenocarcinoma
Nov 14, 2024
10:06
On October 18, 2024, the FDA approved zolbetuximab plus fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of adult patients with locally advanced unresectable or metastatic, HER2-negative, CLDN18.2-positive gastric or GEJ adenocarcinoma. This regulatory decision was backed by findings from the phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials. In SPOTLIGHT, In SPOTLIGHT, patients who received zolbetuximab plus mFOLFOX6 (5-fluorouracil, leucovorin, and oxaliplatin) achieved a median progression-free survival (PFS) of 10.6 months (95% CI, 8.9-12.5) vs 8.7 months (95% CI, 8.2-10.3) in those who received placebo plus chemotherapy (HR, 0.750; 95% CI, 0.601-0.936; 1-sided P = .0053). In GLOW, zolbetuximab plus CAPOX (capecitabine and oxaliplatin) generated a median PFS of 8.2 months (95% CI, 7.5-8.8) vs 6.8 months (95% CI, 6.1-8.1) with placebo plus CAPOX (HR, 0.771; 95% CI, 0.615-0.965; 1-sided P = .0118).
In our exclusive interview, Dr Ajani discussed key considerations for the clinical use of zolbetuximab, including its anticipated adverse effect profile and the introduction of CLDN18.2 as a biomarker for assessment prior to treatment initiation.
In our exclusive interview, Dr Ajani discussed key considerations for the clinical use of zolbetuximab, including its anticipated adverse effect profile and the introduction of CLDN18.2 as a biomarker for assessment prior to treatment initiation.