Date: 2014-10-06
Type of information: Clinical research agreement
Compound: Opdivo® (nivolumab), Zykadia® (ceritinib), INC280, EGF816
Company: Novartis (Switzerland) BMS (USA - NY)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: monoclonal antibody/immune checkpoint inhibitor/tyrosine kinase inhibitor/kinase inhibitor/EGFR inhibitor. Opdivo® (nivolumab) is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. Zykadia® (ceritinib) is indicated in the US for the treatment of patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to crizotinib. INC280 is an orally available selective inhibitor of the c-MET receptor tyrosine kinase. Novartis licensed INC280 from Incyte Corporation and holds exclusive worldwide development and commercialization rights to the compound in all indications. EGF816 (nizartinib) is an orally available, irreversible, third-generation, mutant-selective epidermal growth factor receptor (EGFR) inhibitor. Upon oral administration, EGF816 covalently binds to and inhibits the activity of mutant forms of EGFR, including the T790M EGFR mutant, thereby preventing EGFR-mediated signaling. EGFR, a receptor tyrosine kinase mutated in many tumor cell types, plays a key role in tumor cell proliferation and tumor vascularization. EGF816 preferentially inhibits mutated forms of EGFR including T790M, a secondarily acquired resistance mutation, and may have therapeutic benefits in tumors with T790M-mediated resistance when compared to other EGFR tyrosine kinase inhibitors.
Disease: non-small cell lung cancer
Details: * On October 06, 2014, Novartis announced that it has entered into a clinical collaboration with BMS to evaluate the safety, tolerability and preliminary efficacy of three molecularly targeted compounds in combination with BMS's investigational PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab), in Phase I/II trials of patients with non-small cell lung cancer (NSCLC). Both studies will be conducted by Novartis. One trial will evaluate the combination of Opdivo® with Zykadia® (ceritinib), an FDA-approved treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC who have progressed on or are intolerant to crizotinib. A second study will investigate 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. INC280 and EGF816 are currently being investigated in various Phase I/II NSCLC trials. Additional details of the collaboration were not disclosed. This collaboration with BMS further advances Novartis' 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 PD-1. Novartis is also actively investigating the potential of chimeric antigen receptor (CAR) T cell technologies in the treatment of various liquid and solid tumors through its alliance with the University of Pennsylvania.
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