BRIEF—Bristol-Myers Squibb and Infinity trial Opdivo and IPI-549 in urothelial cancer

Bristol-Myers Squibb and Infinity Pharmaceuticals have entered into a clinical trial collaboration to evaluate B-MS’s blockbuster drug Opdivo (nivolumab) in combination with Infinity's IPI-549 in patients with advanced urothelial cancer.

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.

Infinity will operationalize MARIO-275: MAcrophage Reprogramming in Immuno-Oncology, a global, randomized Phase II study to evaluate 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.

Approximately 150 patients will be randomized between combination therapy and Opdivo monotherapy.

The primary endpoint of the trial will be overall response rate, which will be assessed in the overall population as well as in subsets of patients with different baseline levels of myeloid derived suppressor cells (MDSCs).

In exploratory analyses of the CheckMate -275 data, high levels of MDSCs were associated with shorter overall survival in patients treated with Opdivo.

In Infinity’s MARIO-1 trial, MDSCs were reduced in the majority of patients treated with IPI-549 monotherapy.

IPI-549 in combination with Opdivo has been administered to over 80 patients and demonstrated early evidence of clinical activity with translational studies demonstrating evidence of on-mechanism IPI-549-mediated effects.4