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Bristol-Myers Squibb (BMS) and Daiichi Sankyo announced a collaboration to evaluate the combination of Opdivo (nivolumab) and antibody drug conjugate (ADC) DS-8201 for treating breast and bladder cancers.
On Aug. 28, 2017, Bristol-Myers Squibb (BMS) and Daiichi Sankyo announced a collaboration in a clinical trial to evaluate the combination of BMS’s anti-cancer immunotherapy, Opdivo (nivolumab), and Daiichi Sankyo’s investigational antibody drug conjugate (ADC), DS-8201, for treating metastatic breast and urothelial (bladder) cancers.
Opdivo, a blockbuster anti-cancer drug with 2016 sales of $3.8 billion, is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to harness the body’s own immune system to help restore anti-tumor immune response. The drug is indicated for treating unresectable or metastatic melanoma as a single agent and in combination with Yervoy (ipilimumab), metastatic non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, recurrent or metastatic squamous cell carcinoma of the head and neck, locally advanced or metastatic urothelial carcinoma, and microsatellite instability high or mismatch repair deficient metastatic colorectal cancer.
DS-8201 is the lead investigational product in the ADC franchise of the Daiichi Sankyo cancer enterprise. Using the company’s proprietary ADC technology, the ADC is a chemotherapy comprised of a humanized HER2 antibody attached to a topoisomerase I inhibitor (DXd) payload by a tetrapeptide linker designed to deliver cancer cell destruction upon release inside the cell, and reduce systemic exposure to the cytotoxic payload or chemotherapy, according to the company.
There will be two parts in the Phase 1b study. The dose escalation part will determine a possible recommended dose of DS-8201 in combination with Opdivo in patients with HER2-expressing breast cancer who don’t respond to standard therapies, or for which no standard therapy is available. The dose expansion part of the study will evaluate the efficacy, safety and tolerability of combining Opdivo with DS-8201 at the established dose level in patients with HER2-expressing advanced/metastatic breast cancer, and HER2-expressing urothelial (bladder) cancer in patients previously treated with chemotherapy.
The study will begin enrollment in the first quarter of 2018 in the United States and Europe. Under the agreement, Daiichi Sankyo will sponsor the trial.