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news.Novartis has entered into a clinical collaboration with Bristol-Myers Squibb (BMS) to assess the safety, tolerability and preliminary efficacy of three molecularly targeted compounds in combination with BMS's investigational PD-1 immune checkpoint inhibitor, Opdivo (nivolumab).
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The combination therapies will be evaluated in two Phase I/II trials by Novartis in patients with non-small cell lung cancer (NSCLC).
Novartis’ three molecularly targeted oncology therapies include Zykadia (ceritinib), INC280 and EGF816.
One of the trial is designed to assess the combination of Opdivo with Zykadia, an FDA-approved treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC who have progressed on or are intolerant to crizotinib.
The second trial will evaluate Opdivo with INC280, a potent and highly selective inhibitor of c-MET receptor tyrosine kinase, and separately with EGF816, a potent, third-generation EGFR tyrosine kinase inhibitor that is active against T790 mutations.
Currently, INC280 and EGF816 are being assessed in several Phase I/II NSCLC trials.
Novartis Oncology Development and Medical Affairs global head Alessandro Riva said preclinical data suggests that combining molecularly targeted agents with immunotherapies such as nivolumab may have synergistic effects and lead to better outcomes for patients.
"This collaboration enables us to study several key compounds, including our new highly-potent ALK inhibitor Zykadia, together with a promising, novel immunotherapy agent, paving the way for potential new treatment approaches for patients with NSCLC," Riva said.
According to Novartis, the collaboration with BMS further advances its development efforts in the field of immunotherapy.
Earlier this year, Novartis acquired CoStim Pharmaceuticals, adding late discovery stage immunotherapy programs focused on key oncogenic targets, including programmed death receptor-1 (PD-1).