Specialty Drug Manufacturer Collaboration to Advance Opdivo Research

Bristol-Myers Squibb recently announced a clinical collaboration with Infinity Pharmaceuticals to study the use of Opdivo (nivolumab) in combination with IPI-549 in patients with advanced solid tumors.

Infinity is currently conducting a phase 1 dose-escalation study of IPI-549 in patients with advanced solid tumors. The companies are expected to collaborate to conduct a dose-escalation trial studying the combination of both Opdivo plus IPI-549 this fall, according to a press release from Bristol-Myers Squibb.

Opdivo is an FDA-approved PD-1 immune checkpoint inhibitor, and was the first PD-1 checkpoint inhibitor to receive regulatory approval in any country. It has currently received 54 regulatory approvals since 2004. Opdivo is indicated for patients with metastatic melanoma, non-small cell lung cancer, renal cell carcinoma, and classical Hodgkin lymphoma.

Bristol-Myers Squibb recently supplied the drug to Bavarian Nordic for a clinical trial of non-small cell lung cancer studying a novel combination therapy.

IPI-549 is an investigational immuno-oncology candidate that selectively inhibits PI3K-gamma. It is also the only PI3K-gamma inhibitor in clinical development. The drug has shown the ability to inhibit immune suppressive macrophages in the tumor microenvironment, according to the press release.

Other immunotherapies target immune cell function, which suggests that IPI-549 could be a beneficial part of a combination treatment with a checkpoint inhibitor, such as Opdivo. Preclinical data also found that the drug may overturn tumor resistance to checkpoint inhibitors.

The combination of IPI-549 plus Opdivo is expected to improve and sustain efficacy and tolerability compared with the standard treatment through targeting the immune-suppressive cells in the tumor microenvironment, Bristol-Myers Squibb reported.

“Targeting the tumor microenvironment is an important part of our Immuno-Oncology strategy as we continue to advance research for cancers with limited treatment options,” said Fouad Namouni, MD, head of Oncology Development, Bristol-Myers Squibb. “Our agreement with Infinity builds on our continued focus to bring forward potential novel combination treatment options for patients with cancer.”

The ongoing study of IPI-549 is exploring the activity, safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug, both as a monotherapy and as a combination treatment. The new study exploring the combination treatment will include approximately 175 patients with advanced solid tumors.

After the initial dose-escalation phase is completed, the companies plan to conduct an expansion phase that will assess the combination treatment in select patients with solid tumors, including non-small cell lung cancer, melanoma, and squamous cell carcinoma of the head and neck.

Despite significant progress being made in the oncology world every day, more treatment options are needed for certain groups of patients, such as those being included in the expansion phase, which compose more than 17% of new cancer diagnoses in the US, Bristol-Myers Squibb reported.

“We are excited to explore the potential clinical benefits of combining IPI-549 with Opdivo in the next phase of our ongoing phase 1 study, which is expected to begin this fall,” said Julian Adams, president of research and development at Infinity. “Our preclinical research demonstrates that IPI-549 may enhance the effects of and reverse tumor resistance to checkpoint inhibitors, providing a strong rationale for evaluating this combination in patients with advanced forms of solid tumors.”