HER2-positive gastric cancer, characterized by the overexpression of the human epidermal growth factor receptor 2 (HER2) protein, represents a notable subset of gastric cancers. Recent developments in therapeutic strategies and drug approvals are reshaping the treatment landscape for this aggressive cancer type.
Current Treatment Strategies
HER2-targeted therapies, including trastuzumab (Herceptin), pertuzumab, and trastuzumab deruxtecan, are central to the treatment of HER2-positive gastric cancer. These therapies are often used in combination with chemotherapy, which typically includes fluoropyrimidines, platinum-based agents, and taxanes. For localized or resectable tumors, surgical intervention remains a key option, often followed by adjuvant chemotherapy or HER2-targeted therapy to minimize recurrence risk. Radiation therapy may also be considered for locally advanced or inoperable cases, frequently in conjunction with chemotherapy or surgery.
Recent Approvals and Designations
A significant advancement occurred in December 2022 when the European Union (EU) approved AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) as a monotherapy for adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have previously undergone a trastuzumab-based regimen. This approval provides a crucial new option for patients with limited therapeutic alternatives after initial treatment failure.
In November 2023, Alphamab Oncology and CSPC Pharmaceutical Group Co., Ltd. announced that China's National Medical Products Administration (NMPA) granted Breakthrough Therapy designation to KN026, a HER2 bispecific antibody, in combination with chemotherapy for the treatment of HER2-positive gastric cancer, including gastroesophageal junction cancer. This designation underscores the potential of KN026 as a promising treatment option, expediting its development and regulatory review process.
Emerging Therapies and Market Dynamics
The HER2+ gastric cancer market is anticipated to expand significantly between 2019 and 2032. This growth is fueled by increasing disease prevalence and heightened awareness. The introduction of several pipeline products is expected to revolutionize market dynamics. Key companies in this space include Roche, Elevar Therapeutics, Bristol-Myers Squibb, Merck, Daiichi Sankyo Inc., Genentech, Bayer, Loxo Oncology, Eli Lilly, Remegen Biosciences, AstraZeneca, Hutchison Medipharma Limited, Jiangsu Alphamab Biopharmaceuticals, LintonPharm, Qilu Pharmaceutical Co., and Shanghai Henlius Biotech, among others.
Several therapies are currently in development, including SHR-A1811, Cinrebafusp alfa, and BI-1607. These emerging treatments aim to improve patient outcomes and address unmet needs in HER2-positive gastric cancer management.
Epidemiology and Future Trends
Epidemiological trends indicate a growing prevalence of HER2-positive gastric cancer. Factors driving these trends are being explored through numerous studies and key opinion leader insights. Understanding these trends is crucial for anticipating future healthcare needs and tailoring treatment strategies accordingly.
