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6 Jun 2017

New BMS collaboration to evaluate combination therapy in colorectal cancer

Phase I/II study to evaluate the combination of Opdivo (nivolumab) and Opdivo +Yervoy (ipilimumab) regimen with Mekinist (trametinib) in patients with colorectal cancer.

Bristol-Myers Squibb (BMS) has entered into a clinical research collaboration with Novartis 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).

The Phase I/II 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, head of Oncology Development, BMS.

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

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 US, Japan, and in the European Union.

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