HER2-Positive Gastric Cancer Pipeline Expands with 20+ Therapies in Development

Over 20 pharmaceutical companies are actively developing more than 20 pipeline therapies for HER2-positive gastric cancer treatment, according to a new pipeline analysis. The robust development landscape includes multiple Phase III trials initiated in March 2026 testing novel combination approaches for patients with advanced disease.

On March 16, 2026, Daiichi Sankyo conducted a Phase III clinical trial designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS greater than or equal to 1 gastric or GEJ cancer in the Main Cohort.

On March 09, 2026, AstraZeneca announced a Phase III study to assess the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS greater than or equal to 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.

On March 11, 2026, Astellas Pharma Global Development, Inc. initiated a study to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.

On March 17, 2026, Seagen announced a study will test how safe and how well DV with tucatinib works for participants with solid tumors. This study will also test what side effects happen when participants take these drugs.

Leading companies in the HER2-positive gastric cancer space include Jiangsu HengRui Medicine Co., Ltd., Pieris Pharmaceuticals, BioInvent International, Daiichi Sankyo, AstraZeneca, Shanghai JMT-Bio Inc., Acepodia Biotech, Inc., Klus Pharma Inc., Carisma Therapeutics Inc., Novartis Pharmaceuticals, Celularity Incorporated, Hoffmann-La Roche, DualityBio Inc., Shanghai Miracogen Inc., and Bavarian Nordic. Promising therapies in development include YH32367, BI-1607, Trastuzumab, BDC-1001, Nivolumab, KN026, and BNT323.

Gastric cancer is the sixth most common cancer and the third most common cause of cancer-related death in the world. In some people with stomach cancer, the cancer cells have too much of a growth-promoting protein called HER2 on their surface. Cancers with increased levels of HER2 are called HER2-positive. Drugs that target the HER2 protein can often be helpful in treating these cancers. Unfortunately, only a minority of patients with gastric cancer who undergo surgical resection will be cured of their disease. Most patients have a recurrence.

HER2, also known as ErbB2/Neu, belongs to the EGFR family and is located on human chromosome 17 (17q21); this gene encodes a 185kDa transmembrane glycoprotein (p185). EGFR family members include HER1, HER2, HER3, and HER4, which are composed of three parts: an extracellular ligand-binding domain, a transmembrane domain, and an intracellular tyrosine kinase domain.