Two major international pharmaceutical companies, Novartis and Bristol-Myers Squibb Company, have announced a collaboration to assess the safety, tolerability and efficacy of three investigational drugs, Zykadia, INC280 and EGF816, with Bristol-Meyers Squibb’s experimental PD-1 checkpoint inhibitor, Opdivo (nivolumab), in two Phase I/II clinical trials of patients with non-small cell lung cancer (NSCLC).
“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.” Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs said in a company’s press release.
Zykadia (ceritinib) is used for the treatment of patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to crizotinib, while Opdivo, a human PD-1 immune checkpoint inhibitor, binds to the PD-1 (programmed death-1) receptor expressed on activated T-cells, allowing them to mount an efficient anti-tumoral response.
Both INC280, a strong c-MET receptor tyrosine kinase inhibitor, and EGF816, an EGFR tyrosine kinase inhibitor active against T790 mutations, are investigational compounds whose safety and efficacy has not yet been established, as such, both drugs are currently being tested in several Phase I/II NSCLC clinical trials.
Novartis will conduct both studies, and while one will assess the combination of Opdivo with Zykadia, the other will evaluate Opdivo with either INC280 or EGF816.
The company has been committed in developing its immunotherapy arm, with the acquisition of CoStim Pharmaceuticals Inc. earlier this year extending its programs concerning specific oncogenic targets, such as PD-1. Furthermore, through its collaboration with the University of Pennsylvania, the company is actively exploring the potential of chimeric antigen receptor (CAR) T cell technologies in the treatment of several types of tumors.
