China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clearance from the National Medical Products Administration (NMPA) to conduct an open, multi-center Phase Ib/II clinical study for its investigational HER2-targeted antibody-drug conjugate (ADC), SHR-A1811. The study will evaluate the drug in patients with unresectable or metastatic breast cancer with low HER2 expression, in combination with dalpiciclib, fulvestrant, bevacizumab, or letrozole/anastrozole.
SHR-A1811: Development and Indications
SHR-A1811 is an HER2-targeted ADC designed to deliver cytotoxic agents directly to cancer cells expressing or mutating the HER2 receptor. The drug is currently being evaluated in multiple clinical studies for solid tumors with HER2 expression or mutation. This latest trial aims to further explore its efficacy and safety in breast cancer patients with low HER2 expression.
Global Landscape for HER2-Targeted Therapies
Similar HER2-targeted ADCs are already marketed globally, including Roche’s Kadcyla and AstraZeneca/Daiichi Sankyo’s Enhertu. These therapies have demonstrated significant clinical benefits in treating HER2-positive cancers. Hengrui’s SHR-A1811 aims to expand the treatment options for patients with HER2-expressing tumors, particularly those with low HER2 expression, where therapeutic options remain limited.-Fineline Info & Tech
