Swiss drug maker Novartis has partnered with US-based Bristol-Myers Squibb (BMS) to assess the safety, tolerability and preliminary efficacy of its three molecularly targeted compounds in combination with BMS’s Opdivo (nivolumab).
The investigational PD-1 immune checkpoint inhibitor Opdivo will be tested in Phase I and II trials in combination with Novartis’s Zykadia (ceritinib), INC280, and EGF816. The trials will focus on non-small cell lung cancer (NSCLC).
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.”
The first trial will assess the combination of Opdivo and Zykadia, an FDA-approved treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC.
A second study will test 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.
Novartis will conduct both trials, while INC280 and EGF816 are currently being evaluated in different Phase I/II NSCLC trials.
In 2013, Opdivo received FDA fast track designation to treat NSCLC, melanoma and renal cell carcinoma (RCC).
Earlier this year, the FDA granted breakthrough therapy designation for Opdivo to treat patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab.