Bristol-Myers Squibb and Novartis have entered into a clinical research collaboration to investigate the safety, tolerability and efficacy of Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen in combination with Mekinist (trametinib), 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).
BMS said thta the Phase 1/2 study is expected to establish recommended dose regimens and explore the preliminary anti-tumor activity of combining trametinib with Opdivo, as well as trametinib in combination with the Opdivo + Yervoy regimen. Results will be used to determine optimal approaches to further potential clinical development of these combinations.
“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,” said Fouad Namouni, M.D., head of Oncology Development, Bristol-Myers Squibb.
Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in more than 60 countries including the United States, Japan, and in the European Union.