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Bristol-Myers Squibb, Daiichi Sankyo to evaluate nivolumab plus DS-8201 for breast, urothelial cancers
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Bristol-Myers Squibb and Daiichi Sankyo will collaborate on a trial to evaluate nivolumab plus DS-8201 for the treatment of HER-2-positive metastatic breast and urothelial cancers.
“Combination therapy with agents that target different and complementary pathways — in this case, the combination of a checkpoint inhibitor and innovative chemotherapy delivery — is a potential new approach for patients with difficult-to-treat cancers,” Fouad Namouni, MD, head of oncology development at Bristol-Myers Squibb, said in a press release. “We are looking forward to working with Daiichi Sankyo to investigate the synergies of these treatment methods.”
A multicenter, open-label phase 1b trial will evaluate nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 immune checkpoint inhibitor, in combination with DS-8201 (Daiichi Sankyo), an investigational HER-2-targeting antibody-drug conjugate.
The dose-escalation phase of the trial will be designed to determine the recommended dose of DS-8201 in combination with nivolumab in patients with HER-2-positive breast cancer who are refractory to standard therapies, or for whom no standard therapy is available.
The dose expansion portion of the trial will evaluate the efficacy, safety and tolerability of combining nivolumab with DS-8201 at the established dose level for patients with HER-2-positive advanced or metastatic breast cancer, as well as patients with HER-2-positive urothelial cancer who underwent prior chemotherapy.
Under the terms of the agreement, Daiichi Sankyo will conduct the trial. The companies expect to begin enrollment next year.
“We are excited to evaluate if the combination of these two mechanisms of action — the ability of an anti-PD-1 to harness the immune system and the potential of DS-8201 to deliver chemotherapy directly to target cancer cells — may be able to improve the outcomes of patients with HER-2-expressing advanced breast and bladder cancer,” Antoine Yver, MD, MSc, executive vice president and global head of oncology research and development at Daiichi Sankyo, said in the release. “Pursuing combination studies like this is at the core of the Daiichi Sankyo Cancer Enterprise strategy, as we are looking to maximize the potential of our proprietary antibody-drug conjugate technology to help address the unmet needs of patients living with cancer.”