Tokyo - Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that it has entered into a clinical trial collaboration agreement with a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, U.S.A., known as MSD outside the United States and Canada, to evaluate the combination of DS-1062, a TROP2 directed DXd antibody drug conjugate (ADC), and KEYTRUDA in patients with previously-treated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations.

There are no TROP2 directed therapies and no ADCs currently approved for treatment of NSCLC, which frequently overexpresses the TROP2 protein.[1]

'Strategic research collaborations like this support our goal of developing our TROP2 directed DXd ADC in combination with immune checkpoint inhibitors to improve upon the current standard of care therapies across a wide range of NSCLC subtypes,' said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. 'We look forward to evaluating the safety and efficacy of DS-1062 in combination with KEYTRUDA as a potential combination therapy strategy to advance treatment outcomes for patients with metastatic NSCLC without mutations known to drive cancer growth.'

About the Study

Under the terms of the agreement, Daiichi Sankyo will conduct a multicenter, two-part, open-label, non-randomized, phase 1b study of DS-1062 in combination with KEYTRUDA in patients with advanced or metastatic NSCLC without actionable genomic alterations and previously treated with platinum-based chemotherapy with or without immunotherapy. Patients need to have been previously treated with one regimen of a PD-1/PD-L1 directed immunotherapy, except if patients have a PD-L1 proportion score of

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