Date: 2017-08-28
Type of information: Clinical research agreement
Compound: nivolumab and DS-8201
Company: BMS (USA - NY) Daiichi Sankyo (Japan)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism:
- monoclonal antibody/immune checkpoint inhibitor . Nivolumab is a fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. PD-1, a receptor expressed on the surface of lymphocytes, plays a role in a regulatory pathway that suppresses activated lymphocytes in the body. Available evidence suggests that cancer cells exploit this pathway to escape from immune responses. Opdivo® is thought to provide benefit by blocking PD-1-mediated negative regulation of lymphocytes (i.e., the interaction of PD-1 with its ligands PD-L1 and PD-L2), thereby enhancing the ability of the immune system to recognize cancer cells as foreign and eliminate them.
- antibody drug conjugate. DS-8201a is an investigational antibody drug conjugate comprised of a humanized anti-HER2 antibody attached by a peptide linker to a novel topoisomerase I inhibitor, utilizing Daiichi Sankyo’s proprietary payload and linker-payload technology. It is currently in phase 1 clinical development for HER2 expressing advanced or metastatic breast cancer or gastric cancer and other HER2 expressing solid cancers.
Disease: HER2-expressing metastatic breast cancer, HER2-expressing metastatic urothelial cancer
Details:
- • On August 28, 2017, BMS and Daiichi Sankyo announced a collaborative clinical trial to evaluate the combination of BMS' immunotherapy Opdivo (nivolumab) and Daiichi Sankyo’s investigational antibody drug conjugate DS-8201 in HER2-expressing metastatic breast and urothelial (bladder) cancers.
- The Phase 1b multicenter, open-label study will include two parts. 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 are refractory 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 as well as HER2-expressing urothelial (bladder) cancer in patients previously treated with chemotherapy.
- The study is expected to begin enrollment in first quarter of 2018 in the US and Europe. Under the terms of the agreement, Daiichi Sankyo will be the sponsor conducting the trial.
Financial terms:
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