A clinical trial collaboration has been formed to assess Bristol-Myers Squibb's (BMS) Opdivo in combination with Infinity Pharmaceuticals' IPI-549 in patients with advanced urothelial cancer.
IPI-549 is an oral immuno-oncology development candidate, which is designed to selectively inhibit phosphoinositide-3-kinase (PI3K)-gamma. It is claimed to be the only investigational PI3K-gamma inhibitor in clinical development.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, which is designed to harness the body’s own immune system to help restore anti-tumor immune response.
At present, Opdivo secured approval in over 60 countries, including the US, the EU and Japan.
BMS oncology development head Dr Fouad Namouni said: “The expansion of our relationship with Infinity underscores our efforts to follow the science and support potential novel combination therapies in immuno-oncology for cancer patients with limited treatment options.
Infinity will carry out MARIO-275 (macrophage reprogramming in immuno-oncology) global and randomized phase 2 study to assess the effect of adding IPI-549 to Opdivo in checkpoint-naïve advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy.
The company will randomize around 150 patients between combination therapy and Opdivo monotherapy.
The trial’s primary endpoint will be overall response rate, which will be evaluated in the overall population and in subsets of patients with different baseline levels of myeloid derived suppressor cells (MDSCs).
The FDA approved Opdivo as a single agent in patients with locally advanced or metastatic urothelial cancer who have progressed or recurred following treatment with platinum-based chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
According to BMS, IPI-549 in combination with Opdivo has been administered to more than 80 patients and showed early evidence of clinical activity with translational studies demonstrating evidence of on-mechanism IPI-549-mediated effects.
Infinity is continuing to assess IPI-549 in combination with Opdivo in MARIO-1 phase 1/1b study in patients with advanced solid tumors.
Infinity chief medical officer Dr Sam Agresta said: “We are excited to advance the development of IPI-549 further into the checkpoint inhibitor treatment-naïve setting with this randomized study in collaboration with the team at Bristol-Myers Squibb.”