Date: 2014-08-20
Type of information: Clinical research agreement
Compound: Opdivo® (nivolumab) and Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)
Company: BMS (USA - NY) Celgene (USA - NJ)
Therapeutic area: Cancer - Oncology
Type agreement:
Action mechanism: Opdivo® (nivolumab) is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. BMS is investigating whether by blocking this pathway, OPDIVO would enable the immune system to resume its ability to recognize, attack and destroy cancer cells. Abraxane® is an albumin-bound form of paclitaxel that is manufactured using patented nab® technology. Abraxane® is formulated with albumin, a human protein, and is free of solvents.
Disease: multiple tumor types including HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer (NSCLC)
Details: * On August 20, 2014, BMS and Celgene announced the establishment of a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of BMS’s PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab), and Celgene’s nab® technology-based chemotherapy Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), in a Phase I study. Multiple tumor types will be explored in the study including HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer (NSCLC). The study, which is expected to begin in the fourth quarter of 2014, will be conducted by Celgene. Patients with HER-2 negative breast cancer will be treated with Abraxane® and Opdivo®, patients with NSCLC will be treated with the combination of Abraxane®, carboplatin and Opdivo®, and patients with pancreatic adenocarcinoma will be treated with Abraxane®, gemcitabine and Opdivo®. Additional details of the collaboration were not disclosed.
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