Bristol-Myers Squibb and Infinity Pharmaceuticals have teamed up to study tumour resistance to checkpoint inhibitors in BMS’ immuno-oncology drug Opdivo (nivolumab).
The partners are due to begin their clinical trial collaboration before the end of the year, when they will combine Opdivo with Infinity’s candidate IPI-549 to evaluate its potential for improving sustained efficacy and tolerability beyond the current standard of care.
Preclinical data for IPI-549 – which is currently in phase I trials as a monotherapy – has suggested that the drug candidate may not only enhance the effects of checkpoint inhibitors like Opdivo, but also reverse tumour resistance.
Designed to target immune cells, IPI-549 alters the immune-suppressive microenvironment that fosters tumour growth and promotes an anti-tumour immune response.
Dr Fouad Namouni, head of oncology development at BMS, said: “Targeting the tumour microenvironment is an important part of our immuno-oncology strategy as we continue to advance research for cancers with limited treatment options.
“Our agreement with Infinity builds on our continued focus to bring forward potential novel combination treatment options for patients with cancer.”
With a view to treating all patients with advanced forms of solid tumours, the study will begin with trials in non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN), which account for 17% of all new cancer cases in the US each year.
BMS will be looking to the combination therapy to give its PD-1 inhibitor an advantage in the hyper-competitive immuno-oncology market, particularly after Opdivo failed to outperform Merck & Co’s Keytruda (pembrolizumab) in a first-line NSCLC study earlier this year.
In that study Merck’s Keytruda proved to better both progression-free and overall survival in NSCLC patients compared to standard chemotherapy and it was followed by an accelerated approval by the FDA last month.
Meanwhile, Roche’s own PD-1 inhibitor Tecentriq (atezolizumab) has also been approved in NSCLC albeit as a second-line therapy and is currently undergoing a phase III trial for first-line use.