Infinity Pharmaceuticals has entered into a master clinical supply agreement under which Roche will supply atezolizumab (Tecentriq®) to Infinity for use in MARIO-3, a Phase 2 multi-arm combination cohort study. The study will evaluate IPI-549, Infinity's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma, in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC) beginning in the second half of 2019.
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"We are very pleased to have entered into this agreement with Roche to evaluate combinations including IPI-549 and Tecentriq in front-line solid tumor settings," said Sam Agresta, M.D., M.P.H., Chief Medical Officer at Infinity. "MARIO-3 is a key part of our strategy to expand the breadth and depth of the development of IPI-549 into earlier lines of therapy and in combination with potentially transformative new treatment regimens for patients. We look forward to initiating MARIO-3 later this year."
MARIO-1 is an ongoing Phase 1/1b study evaluating IPI-549 as a monotherapy and in combination with Opdivo® (nivolumab) in approximately 225 patients with advanced solid tumors including patients refractory to anti-PD-1 therapy. Infinity intends to initiate MARIO-275, a global, randomized, combination study of IPI-549 combined with Opdivo in I/O naïve urothelial cancer patients, as well as to initiate MARIO-3, the first IPI-549 combination study in front-line advanced cancer patients. MARIO-3 will evaluate IPI-549 in combination with Tecentriq and Abraxane in front-line TNBC and in combination with Tecentriq and Avastin in front-line RCC. With the addition of MARIO-275 and MARIO-3 to the ongoing MARIO-1 study, Infinity will be evaluating IPI-549 in the anti-PD-1 refractory, I/O-naïve, and front-line settings.