NEW YORK – Daiichi Sankyo said on Wednesday that it has dosed the first triple-negative breast cancer patient in a Phase I study evaluating the investigational agent DS-1062.
The TROP2-directed DXd antibody-drug conjugate previously demonstrated encouraging efficacy in non-small cell lung cancer patients. Based on that, Daiichi Sankyo expanded the study to include TNBC patients, who lack treatment options since their tumors lack expression of HER2, estrogen, and progesterone receptors. However, up to 80 percent of TNBC patients have high TROP2 expression.
"We continue to follow the science to determine whether DS-1062, designed with our proprietary DXd ADC technology, could serve as a new TROP2-directed therapy option for patients with TNBC and other cancers," Gilles Gallant, senior VP and global head of oncology R&D at Daiichi Sankyo, said in a statement.
The ongoing dose escalation and expansion Phase I trial will evaluate the safety, tolerability, and preliminary efficacy of DS-1062 in patients with TROP2 unselected advanced solid tumors, who have become refractory or relapsed on standard treatment. The study is enrolling 180 patients with unresectable advanced NSCLC in the US and in Japan, and around 40 patients with unresectable, advanced, or metastatic TNBC.
The study will track patients' toxicities and adverse events on DS-1062, as well as various efficacy endpoints, such as objective response rate, duration of response, progression-free survival, and overall survival. Researchers will also assess biomarkers of response and immunogenicity endpoints.