Novartis, Bristol-Myers Squibb to Evaluate Potential Metastatic Colorectal Cancer Treatments

Novartis announced it has entered into a clinical research collaboration in which Bristol-Myers Squibb will 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).

Under the terms of the agreement, the study will be conducted by Bristol Myers-Squibb and is expected to establish recommended dose regimens and the preliminary anti-tumor activity of the combination therapies. Both Bristol Myers-Squibb and Novartis will evaluate the results to determine optimal approaches and potential clinical development of these combinations.

"Novartis has a longstanding heritage in exploring the combination of medicines to broaden our knowledge of mutational driven cancers and develop innovative treatments," Vas Narasimhan, MD, Head, Global Drug Development and Chief Medical Officer, Novartis said. "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."

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 worldwide. Of these, nearly 750,000 were diagnosed in men, and 614,000 in women. In the U.S., an estimated 135,430 patients will be diagnosed with cancer of the colon or rectum in 2017, and approximately 50,000 are estimated to die of their disease. There is wide variation in 5-year survival rates across disease stages, with 5-year survival rates for patients with metastatic or stage IV colorectal cancer around 11%. The incidence of microsatellite stability (MSS) in colorectal tumors varies by stage, with 80% to 85% of exhibiting MSS.