A new clinical collaboration between Novartis and Bristol-Myers Squibb Company (BMS) has been announced to evaluate the effectiveness of three molecularly targeted compounds in combination with BMS’s Opdivo (nivolumab) in Phase I/II trials of patients suffering with non-small cell lung cancer (NSCLC).
This immunotherapy study will be lead by Novartis and it will be divided in two threads: one trial will evaluate the combination of Opdivo with Zykadia (ceritinib) and the other will focus on the the interaction of Opdivo with INC280 and, separately, with EGF816, two investigational drugs.
“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,” explained Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs in a Novartis press release.
Opdivo is an investigational PD-1 (programmed death 1) immune checkpoint inhibitor, that is capable of biding himself to the PD-1 receptor when T-cells are activated. Cancer cells exploit regulatory pathways and checkpoint pathways to protect themselves from the immune system and they often express the PD-1 ligand. If this ligand binds the PD-1 receptor in T-cells, they become inhibited from attacking the tumor, allowing cancer to acquire a “shield” against the immune system. Opdivo blocks this attack-defense mechanism.
Zykadia is an FDA-approved drug for the treatment of patients suffering with anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC that has continued progressing or revealed to be intolerant to crizotinib. INC280 and EGF816 are investigational compounds that are only accessible in carefully monitored clinical trials, since their profile has not been established.
This collaboration highlights Novartis’ efforts in the immunotherapy field and in this enormous battle against cancer. Novartis recently acquired CoStim Pharmaceuticals Inc. and included immunotherapy programs focused on oncogenic targets like PD-1 in their research goals. These now lay side-by-side with their investigation projects of chimeric antigen receptor (CAR) T-cell technologies to treat several liquid and solid tumors.