Novartis and Bristol-Myers Squibb have signed a clinical research pact to investigate the safety, tolerability, and efficacy of combining their respective drugs Mekinist and Opdivo.
The plan is to carry out a Phase I/II study assessing Mekinist (trametinib) with both Opdivo (nivolumab) alone and Opdivo plus Yervoy (ipilimumab) as a potential treatment for metastatic colorectal cancer, specifically in patients with microsatellite stable tumours where the tumours are proficient in mismatch repair (MSS mCRC pMMR).
The study is to be conducted by BMS and is expected to establish recommended dose regimens and the preliminary anti-tumour activity of the combination therapies.
Both parties will evaluate the results to determine optimal approaches and potential clinical development of these combinations.
The move expands on the companies’ 2014 agreement to evaluate the potential of combining Novartis compounds with Opdivo in non-small-cell lung cancer.
"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,” said Novartis’ chief medical officer and head of global drug development Vas Narasimhan, commenting on the deal.
Further terms of the deal were not disclosed.
Tasigna label update
Meanwhile, Novartis also announced that European regulators have approved the inclusion of treatment-free remission (TFR) data in Tasigna (nilotinib)’s label.
TFR is the ability to maintain molecular response after stopping tyrosine kinase inhibitor (TKI) therapy in Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase.
Tasigna is now the first and only TKI to include information on TFR in the European Union label, the drug giant noted.