NEW YORK – Daiichi Sankyo and Goustave Roussy have entered into a multi-year collaboration to study and develop two of Daiichi's lead DXd antibody drug conjugates, DS-1062 and patritumab deruxtecan, in lung and breast cancer indications and look for biomarkers of response and resistance.
Under the terms of the agreement, Daiichi will provide funding and support to Gustave Roussy for clinical, translational, and preclinical studies involving these two agents.
Researchers will conduct an adaptive Phase II study to evaluate the safety and efficacy of DS-1062 in advanced NSCLC patients who have progressed on anti-PD-1/PD-L1 treatments and platinum-doublet chemotherapy, and attempt to identify markers of response and resistance. In a second adaptive Phase II trial involving patritumab deruxtecan researchers will evaluate safety and efficacy in HER3-expressing, metastatic breast cancer patients, and also look for predictive biomarkers.
Each study will involve up to 100 patients who will be enrolled at multiple study sites in France. The primary endpoint in the studies is objective response rate, but a main focus will also be to analyze biomarker expression and tumor sensitivity.
"This innovative research program includes two precision medicine rich Phase II trials designed with an adaptive approach to help determine which patients are most likely to benefit from our [antibody drug conjugates] with optimal speed and efficiency," Antoine Yver, Daiichi's global head of oncology R&D, said in a statement. "Combination therapy strategies will also be explored in other studies."