Infinity Pharmaceuticals provides additional information on MARIO-8 study design

Infinity Pharmaceuticals (INFI) announced further design features of its Phase 2 MARIO-8 study in SCCHN. The adaptive design of the MARIO-8 study is intended to optimize the dose of the oral drug candidate, eganelisib, in combination with the standard dose of pembrolizumab, in 40-70 patients in Part A of the study. The dose optimization phase of the study will evaluate two dose regimens of eganelisib; a 30mg regimen, dosed daily for two out of every three weeks, and a 20mg regimen, with continuous daily dosing. The company has received FDA feedback and, pending final FDA review and subject to the successful close of the company’s proposed merger with MEI Pharma (MEIP), preliminary safety and efficacy data to inform the dose selection are expected in the second half of 2024. The selected eganelisib dose, in combination with pembrolizumab, will be further evaluated in Part B of the study in approximately 100 additional patients, with the primary endpoint of overall survival and secondary endpoints of progression free survival and safety.