Colorectal cancer is the third most common type of cancer in men and the second most common in women, with approximately 1.4 million new diagnoses in 2012. For the same period, approximately 694,000 deaths worldwide were attributed to colorectal cancer.
Healthcare solutions provider Novartis is working with pharma company Bristol-Myers Squibb to investigate the safety, tolerability, and efficacy of Mekinist (trametinib) in combination with Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a potential treatment option for metastatic colorectal cancer in patients with microsatellite stable tumors where the tumors are proficient in mismatch repair (MSS mCRC pMMR).
The two companies aim to establish recommended dose regimens and the preliminary anti-tumor activity of the combination therapies.
“Novartis has a long-standing heritage in exploring the combination of medicines to broaden our knowledge of mutational driven cancers and develop innovative treatments,” said Dr. Vas Narasimhan, head of global drug development and chief medical officer at Novartis. “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 to support patients in need.”
Mekinist is a kinase inhibitor indicated, as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
Mekinist is not indicated for the treatment of patients who have received prior BRAF-inhibitor therapy. Mekinist can cause serious side effects including new primary malignancies (cutaneous and non-cutaneous), hemorrhage, inflammation of the colon and perforation of the intestines, blood clots in the legs, cardiomyopathy, eye toxicity, interstitial lung disease, serious fevers, serious skin toxicity, hyperglycemia, and harm to a fetus.
Some of these side effects can be fatal in rare cases. The most common side effects when Mekinist is used as a single-agent are rash, diarrhea, and lymphedema.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
To date, the Opdivo clinical development program has enrolled more than 25,000 patients.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union, and Japan.
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