Policy & Regulation
Bristol-Myers Squibb establishes clinical trial collaboration with Infinity Pharmaceuticals
7 November 2018 -

United States-based Bristol-Myers Squibb has established a clinical trial collaboration with United States-based Infinity Pharmaceuticals to evaluate Bristol-Myers Squibb's Opdivo in combination with Infinity Pharmaceuticals' IPI-549 in patients with advanced urothelial cancer, it was reported yesterday.

The product 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-tumour immune response. Infinity will conduct the MARIO-275 (macrophage reprogramming in immuno-oncology) global and randomised phase two study to assess the effect of adding IPI-549 to Opdivo in checkpoint-naive advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy. The company will randomise 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).

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