Also known as: CLDN18.2
ABL111 received FDA agreement on an accelerated approval pathway for metastatic gastric cancer as the first patient was dosed in a global phase 2 trial. The companies said ORR will support accelerated approval and phase 2 is evaluating ABL111 with nivolumab and mFOLFOX6.
AstraZeneca will report pivotal first-half data on sonesitatug vedotin in Claudin18.2 gastric cancer. The phase 3 Clarity-Gastric01 study is enrolling patients with ≥25% expression.
VYLOY (zolbetuximab-clzb) remains the only approved CLDN18.2-targeted therapy for first-line HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumors. The pipeline is focused on next-generation antibodies, ADCs, CAR-T, NK-cell and bispecific approaches aiming to build on zolbetuximab benchmark data.
New ASCO guideline emphasizes biomarker-driven treatment for advanced gastroesophageal cancer, recommending upfront testing for HER2, PD-L1, MSI/MMR, and CLDN18.2 to guide immunotherapy and targeted therapy selection.
NovaBridge Biosciences has enrolled the first patient in a global Phase 2 study evaluating givastomig in combination with nivolumab and chemotherapy for HER2-negative, first-line metastatic gastric cancer, with top-line results expected in 2027.
