On July 22, 2020 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Gustave Roussy reported a multi-year, multi-study research collaboration to enrich and further enable the development of DS-1062 and patritumab deruxtecan (U3-1402), two of Daiichi Sankyo’s lead DXd antibody drug conjugates (ADCs), in lung and breast cancer (Press release, Daiichi Sankyo, JUL 22, 2020, View Source [SID1234562222]).
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The collaboration will focus on clinical and translational research, including potential combination strategies for DS-1062, a TROP2 directed DXd ADC, in patients with advanced non-small cell lung cancer (NSCLC), and for patritumab deruxtecan, a HER3 directed DXd ADC, in patients with metastatic breast cancer.
"We look forward to engaging and collaborating with the deep expertise and cutting-edge oncology research capabilities of Gustave Roussy, the premier European Cancer Center, to further advance clinical development of DS-1062 and patritumab deruxtecan," said Antoine Yver, MD, MSc, AIHP, ACCA Paris, Global Head, Oncology R&D, Daiichi Sankyo. "This innovative research program includes two precision-medicine rich phase 2 trials designed with an adaptive approach to help determine which patients are most likely to benefit from our ADCs with optimal speed and efficiency. Combination therapy strategies will also be explored in other studies."
"This partnership is strategic for Gustave Roussy and it brings together all the skills which are essential for top quality research in oncology. Launching clinical trials to test two promising molecules in advanced non-small cell lung cancer and metastatic breast cancer is essential for diseases which unfortunately have an increasing incidence and for which there is an urgent need to make progress," said Prof. Jean-Charles Soria, General Director of Gustave Roussy. "It is by pushing the boundaries of innovation that we will further improve the quality of care for our patients."
About the Collaboration
Under the agreement, Daiichi Sankyo, Inc. will provide funding and support to Gustave Roussy for a comprehensive, integrative research program including clinical, translational and preclinical studies for DS-1062 and patritumab deruxtecan in lung and breast cancer, respectively.
Two adaptive phase 2 trials will be conducted, including a multicenter, open-label study to evaluate efficacy, safety and markers of response and resistance to DS-1062 in patients with advanced NSCLC who have progressed on anti-PD-1/PD-L1 therapy and platinum-doublet chemotherapy.
The second multicenter, open-label phase 2 study will evaluate the efficacy, safety and biomarkers of response and resistance to patritumab deruxtecan in patients with HER3 expressing metastatic breast cancer.
Each study will enroll up to 100 patients and will be conducted in several sites in France.
The primary endpoint for both studies is objective response rate as assessed by independent central review. Secondary endpoints include clinical benefit rate, progression-free survival, duration of response, overall survival and safety measures. The studies also will primarily be conducted to analyze biomarker expression and tumor sensitivity; the role of receptor biology in the pharmacological activity of the Daiichi Sankyo DXd ADC platform, as well as factors contributing to treatment resistance; immunogenicity and mechanism of action.
The adaptive trial design includes ongoing clinical and biomarker assessments to identify factors associated with individual patient response and the ability to fine-tune development accordingly.
Additional research to be conducted under the collaboration includes several studies exploring multiple therapeutic combinations for each ADC.