Bristol-Myers Squibb (BMS) today disclosed a pair of combination-therapy cancer collaborations involving its Opdivo (nivolumab)—a clinical trial partnership to assess the effect of the investigational immunotherapeutic with Novartis’ Zykadia (ceritinib) and two drug candidates; and a clinical research partnership with the University of Texas MD Anderson Cancer Center to evaluate Opdivo, the already-marketed Yervoy (ipililumab) and three BMS drug candidates.
The value of both collaborations was undisclosed.
In the collaboration with Novartis, the Swiss pharma giant will conduct two Phase I/II studies focused on non-small cell lung cancer (NSCLC).
In one of those studies, BMS will assess the safety, tolerability and preliminary efficacy of combining its Opdivo with Novartis’ Zykadia (ceritinib)—approved April 29 by the FDA as the first therapy marketed for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC who have progressed on or are intolerant to crizotinib.
In the other study, Opdivo will be assessed separately with two Novartis experimental drugs—INC280, designed to work as a potent and highly selective inhibitor of c-MET receptor tyrosine kinase; and EGF816, designed as a potent, third-generation EGFR tyrosine kinase inhibitor that is active against T790 mutations.
The two compounds are currently being investigated in various Phase I/II NSCLC trials, according to Novartis.
Novartis said its collaboration with BMS reflected a greater focus on cancer immunotherapy. In February, Novartis acquired CoStim Pharmaceuticals for an undisclosed price, adding late discovery stage immunotherapy programs focused on key oncogenic targets, including programmed death receptor-1 (PD-1).
PD-1 inhibition is under study in new cancer treatments being developed by several pharma giants . Just last month, Merck & Co. won FDA approval for the first PD-1 inhibitor allowed for use as a drug in the U.S., its melanomaimmunotherapy Keytruda (pembrolizumab), formerly called MK-3475.
Novartis said it continues to investigate 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.
Separately, BMS said it will join with MD Anderson to assess potential treatments for acute and chronic leukemia, as well as other blood cancers, that combine Opdivo with Yervoy and three BMS compounds the company only described as “early-stage clinical immuno-oncology assets”
BMS said the collaboration will launch up to 10 Phase I and II clinical trials, to be conducted by MD Anderson, focused on evaluating investigational immune-based approaches for acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), chronic myeloid leukemia (CML), myelodysplastic syndrome (MDS) and myelofibrosis (MF).
Additional studies will be determined by the collaboration at a later date, BMS added.
Opdivo is a PD-1 immune checkpoint inhibitor approved in Japan for the treatment of patients with unresectable melanoma. July 4 that Opdivo won manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma, BMS partner Ono Pharmaceutical said.
In the U.S., BMS said September 26 the FDA accepted for priority review the Biologics License Application (BLA) of Opdivo for previously treated advanced melanoma, with the drug assigned a Prescription Drug User Fee Act (PDUFA) goal date for a decision of March 30, 2015. The FDA also granted Breakthrough Therapy status to Opdivo for that indication, in addition to the Breakthrough Therapy Designation granted in May for treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab.
In April 2014, BMS launched a rolling submission with the FDA for Opdivo in third-line pre-treated squamous cell NSCLC. The company said today it expects to complete the submission by year-end. The FDA granted Opdivo a Fast Track designation last year in NSCLC, melanoma and RCC.
Yervoy is a CTLA-4 immune checkpoint inhibitor approved in the U.S. and more than 40 countries for patients with unresectable or metastatic melanoma.
The collaboration with MD Anderson is part of BMS’ 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, the company said.
Among the trials, according to BMS, are several potentially registrational studies in NSCLC, melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin lymphoma.
