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BMS and Lilly to jointly research Opdivo combination

PD-1 inhibitor will be tested with Lilly's galunisertib
Bristol-Myers Squibb logo

Bristol-Myers Squibb is to evaluate the efficacy of Opdivo (nivolumab) with Eli Lilly's galunisertib as the companies join forces to assess their potential for treating advanced solid tumours.

A phase I and II trial programme will evaluate the safety, tolerability and efficacy of the combination in patients with advanced glioblastoma, hepatocellular carcinoma and non-small lung cancer.

Michael Giordano, senior VP and head of development of oncology at BMS, said: “Advanced solid tumours represent a serious unmet need among patients with cancer.

“Our clinical collaboration with Lilly underscores BMS' continued commitment to explore combination regimens from our immune-oncology portfolio with other mechanisms of action that may accelerate the development of new treatment options for patients.”

Opdivo last year became the first anti PD-1 to be approved, when Japanese regulatory licensed it for melanoma that is not treatable with surgery and this was followed late last year by FDA approval.

It was been trialled with Lilly's galunisertib, a TGF beta R1 kinase inhibitor that is in phase I and II trials and works by blocking TGF beta signalling. TGF beta promotes tumour growth, suppresses the immune and increases the ability of tumours to spread around the body.

Lilly will conduct the study, aiming to address the hypothesis that co-inhibition of PD-1 and TGF beta negative signals may create enhanced anti-tumour immune responses.

Richard Gaynor, senior VP of product development and medical affairs, added: “Combination therapies will be key to addressing tumour heterogeneity and the inevitable resistance that is likely to develop to even the most promising new tailored therapies.

“To that end, having multiple cancer pathways and technology platforms will be critical in an era of combinations to ensure sustainability beyond any single asset.”

BMS could see an early UK launch of Opdivo after becoming the first drug of its class to be given fast-track status by the Early Access to Medicines Scheme (EAMS), which launched in April 2014.

Article by
Kirstie Pickering

14th January 2015

From: Research



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