Bristol-Myers Squibb and Infinity to collaborate on Opdivo (nivolumab) plus IPI-549 solid tumours study
Posted: 11 November 2016 | | No comments yet
Bristol-Myers Squibb and Infinity will collaborate on a solid tumours trial to evaluate Bristol-Myers Squibb’s Opdivo in combination with Infinity’s…
Bristol-Myers Squibb and Infinity will collaborate on a clinical trial to evaluate Bristol-Myers Squibb’s Opdivo in combination with Infinity’s IPI-549 in patients with advanced solid tumours.
The dose-escalation portion exploring IPI-549 as a monotherapy in Infinity’s Phase 1 study is continuing, and the first dose-escalation cohort studying IPI-549 in combination with Opdivo, a PD-1 immune checkpoint inhibitor, is expected to begin this fall.
IPI-549 is an oral immuno-oncology development candidate that is designed to selectively inhibit phosphoinositide-3-kinase (PI3K)-gamma and is the only investigational PI3K-gamma inhibitor in clinical development.
Preclinical predictions
Preclinical data suggest that IPI-549 may enhance the effects of checkpoint inhibitors and may also reverse tumour resistance to checkpoint inhibitors by targeting immune cells and altering the immune-suppressive microenvironment, promoting an anti-tumour immune response.
Opdivo is designed to overcome immune suppression. The combination phase of this ongoing Phase 1 study in patients with advanced solid tumours will explore the potential of combining these two agents to drive improved and sustained efficacy and tolerability above the current standard of care by targeting the immune-suppressive cells in the tumour microenvironment.
Julian Adams, Infinity, stated, “Our preclinical research demonstrates that IPI-549 may enhance the effects of and reverse tumour resistance to checkpoint inhibitors, providing a strong rationale for evaluating this combination in patients with advanced forms of solid tumours.”
Evaluating dose escalation
The ongoing Phase 1 clinical study of IPI-549 is designed to explore the activity, safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 175 patients with advanced solid tumours.
Once the dose-escalation phase evaluating Opdivo plus IPI-549 is completed, an expansion phase is planned to evaluate the combination in patients with selected solid tumours, including non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN).
Treatment urgently needed
Although there has been great progress in the treatment of cancer, there remains a need for additional treatment options. NSCLC, melanoma and SCCHN, which will comprise three of the expansion cohorts in this Phase 1 study, account for more than 17% of all new cancer cases in the US.
Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 54 countries including the United States, Japan, and in the European Union.
