Bristol-Myers Squibb (BMS) will carry out a Phase I/II study assessing both its Opdivo® (nivolumab) and its Opdivo + Yervoy® (ipilimumab) regimen in combination with Novartis’ Mekinist® (trametinib) in metastatic colorectal cancer.
The clinical research collaboration—whose value was not disclosed—will entail a study of the safety, tolerability, and efficacy of the combinations in patients with microsatellite stable tumors, where the tumors are proficient in mismatch repair [microsatellite stable (MSS), metastatic colorectal cancer (mCRC), mismatch repair proficient (pMMR)].
BMS will conduct the study and is expected to establish recommended dose regimens as well as the preliminary antitumor activity of the combination therapies. BMS and Novartis plan to evaluate the results to determine optimal approaches and determine potential clinical development of these combinations.
The study marks an expansion of an ongoing partnership by the two pharma giants, launched in 2014 and initially focused on combining cancer treatments of the companies in order to fight non-small-cell lung cancer.
“Along with our ongoing internal immuno-oncology efforts, the expansion of our collaboration with BMS further advances our collective goals to advance the science and support patients in need,” Vas Narasimhan, M.D., head, global drug development and CMO, Novartis, said yesterday in a statement.
The new clinical collaboration helps fulfill one of BMS’ priorities as expressed during a presentation this week at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. BMS evp and CSO Thomas J. Lynch, Jr., M.D., identified among the company’s priorities expansion of Opdivo and Yervoy development across multiple tumors and biomarker sets.
Mekinist is a kinase inhibitor indicated as both a single agent and in combination with Novartis’ marketed cancer drug Tafinlar® (dabrafenib) for patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. Mekinist is not indicated for treatment of patients who have received prior BRAF-inhibitor therapy.
Opdivo was the first programmed cell death protein 1 (PD-1) immune checkpoint inhibitor to receive regulatory approval anywhere in the world in 2014 and now has regulatory approval in more than 60 countries, including the U.S., the EU, and Japan.
Yervoy is a recombinant human monoclonal antibody designed to work by binding to cytotoxic T- lymphocyte-associated antigen-4 (CTLA-4) and blocking the interaction of CTLA-4 with its ligands, CD80/CD86. Since its initial approval in 2011, Yervoy has been approved in more than 40 countries worldwide.
