On Monday, the Bristol-Myers-Squibb pharmaceuticals company announced the start of its clinical research collaboration with industry contemporary Novartis in order to investigate the safety, tolerability, and efficacy of the Opdivo (nivolumab) and Opdivo + Yervoy (ipilumamb) regimen when taken in combination with Mekinist® (trametinib) as the potential treatment for metastatic colorectal cancer in patients who specifically have microsatellite stable tumors wherein these tumors are well within mismatch repair.
They expect for this Phase 1/2 study to establish what should be the recommended dose regimens as well as to explore any preliminary anti-tumor activity when combining combining trametinib with either of the Opdivo regimens. The researchers, then, will use these results to determine the best possible approach for potential combination developments in the future.
According to Bristol-Myers-Squibb head of Oncology, Fouad Namouni, MD, “We continue to investigate novel combinations of therapy that may hold the potential to expand the therapeutic benefits of immunotherapy to patients with difficult to treat cancer or those who don’t respond, and look forward to evaluating the combination of Novartis’ MEK inhibitor with our immunotherapies.”
In case you are not aware, Opdivo is the first PD-1 immune checkpoint inhibitor to earn regulatory approval, globally, receiving its approval in July of 2014. In addition, it also currently has approval in more than 5 dozen countries including, Japan, the European Union, and, of course, the United States.
In this new agreement, Bristol-Myers-Squibb will conduct the study, hoping to establish both the recommended dosages as well as the preliminary anti-tumor activity.
Novartis Head of Global Drug Development, and Chief Medical Officer, Vas Narasimhan, MD, notes, “Novartis has a longstanding heritage in exploring the combination of medicines to broaden our knowledge of mutational driven cancers and develop innovative treatments. Along with our ongoing internal immuno-oncology efforts, the expansion of our collaboration with Bristol-Myers Squibb further advances our collective goals to advance the science and support patients in need.”
Of course, this could be a major advance, as colorectal cancer is the third most common type of cancer in men and the second most common type of cancer in women around the world. In 2012, for example, there were more than 1.4 million new diagnoses at a ratio of about 750,000 men to 614,000 women. That year, more than 694,000 deaths were attributed to complications of colorectal cancer, globally.