New Drug: Zolbetuximab with FOLFOX for Gastric and GE Junction Cancer
Study
Phase 3, multicenter, randomized, double-blind trial (SPOTLIGHT)
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Locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, CLDN18.2-positive, HER2-negative
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Zolbetuximab plus mFOLFOX6 (n=279) vs. Placebo plus mFOLFOX6 (n=278)
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Efficacy
ORR: 48% vs. 48%
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mPFS: 10.6 vs. 8.7 mos (HR: 0.75 [0.60-0.94])
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mOS: 18.2 vs. 15.5 mos (HR: 0.75 [0.60-0.94])
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Safety
Grade >=3 AEs: Nausea (16% vs. 6%), neutropenia (28% vs. 23%),
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Shitara K Zolbetuximab plus mFOLFOX6 in patients with
CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial
Reviewed by Ulas D. Bayraktar, MD on Nov 11, 2024