Novartis has entered into a clinical collaboration with Bristol-Myers Squibb to evaluate the safety, tolerability, and preliminary efficacy of three molecularly targeted compounds in combination with Bristol-Myers Squibb’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 Novartis’s 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, two Novartis investigational compounds, are currently being investigated in various Phase I/II NSCLC trials. Novartis licensed INC280 from Incyte Corporation and holds exclusive worldwide development and commercialization rights to the compound in all indications. Additional details of the collaboration were not disclosed.

This collaboration with Bristol-Myers Squibb further advances Novartis’ development efforts in the field of immunotherapy. Earlier this year, Novartis acquired CoStim Pharmaceuticals Inc., 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.

Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 35 trials, as monotherapy or in combination with other therapies, in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma, and non-Hodgkin lymphoma.

In 2013, the FDA granted Fast Track designation for Opdivo (nivolumab) in NSCLC, melanoma and RCC. In April 2014, the company initiated a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC and expects to complete the submission by year-end. The FDA granted Opdivo Breakthrough Therapy Designation in May 2014 for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab. On July 4, 2014, Ono Pharmaceutical Co. announced that Opdivo received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma, making Opdivo the first PD-1 immune checkpoint inhibitor to receive regulatory approval, according to Bristol-Myers Squibb. Through a collaboration agreement with Ono Pharmaceutical in 2011, Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo (nivolumab) globally except in Japan, Korea, and Taiwan, where Ono has retained all rights to the compound. 

Source: Novartis and  Bristol-Myers Squibb