Also known as: CLDN18.2
A rare BTK A428D mutation causes resistance to all BTK-targeted therapies, finds a new study. China is reviewing the first CAR-T therapy for gastric cancer, and research reveals why BET inhibitors fail and targets AML's DNMT3A mutation.
Four biomarkers—MMR, HER2, PD-L1, and Claudin 18.2—are now validated for advanced esophageal cancer, guiding immunotherapy and targeted treatment decisions. Checkpoint inhibitors show clear benefit in MSI-H and PD-L1-positive subgroups, with long-term survival observed. NCCN guidelines recommend broad testing to personalize therapy.
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.
