The clinical trial will test the safety and efficacy of Daiichi Sankyo’s HER2 targeting antibody-drug conjugate, (ADC) DS-8021, alongside Keytruda (permbrolizumab) in HER2 expressing advanced/metastatic breast and HER2 expressing or HER2 mutant non-small cell lung cancers (NSCLC).
A spokesperson from Daiichi Sankyo told us, “Preclinical studies have shown potential synergistic effects between DS-8201 and anti-PD-1 checkpoint inhibitors, suggesting a combination of these two agents may result in improved efficacy compared to each agent alone, given their unique mode of actions.”
DS-8201 works to deliver targeted cytotoxic chemotherapy to cancer cells via an attached monoclonal antibody. DS-8201, according to the company, is made up of a humanized HER2 antibody that is attached to a topoisomerase I inhibitor payload.
The drug is designed to target cancer cells as a way to reduce exposure to the cytotoxic chemotherapy payload and has been granted breakthrough therapy designation. Per the collaboration, Daiichi Sankyo will conduct a two-part Phase Ib multicenter open-label study.
The primary endpoints will be maximum tolerated dose and overall response rates. The study is expected to enroll roughly 125 patients in the US and Europe.