Data: 49 patients were enrolled in the MARIO-275 study designed to evaluate it as a combination therapy with Bristol-Myers Squibb Co's (NYSE: BMY) Opdivo (nivolumab) in platinum-refractory, I/O naïve patients with advanced urothelial cancer.
In the combination arm, the median overall survival (mOS) in the intent to treat (ITT) population stood at 15.4 months versus 7.9 months on the control arm of nivolumab alone, reflecting a 38% lower probability of death on the combination arm.
At year one, 59% of patients in the ITT population receiving the combo were alive compared to 32% in the control arm. mOS benefit was similar across those with PD-L1(-) tumors and in the ITT population, while most common treatment-emergent adverse events (TEAEs) included pyrexia (33.3%) and decreased appetite (30.3%).
There were no Grade 5 hepatic AEs, the Company said. Meanwhile, the MARIO-3 was designed to evaluate eganelisib in a front-line setting as a triple combination with Roche Holding AG's (OTC: RHHBY) Tecentriq (atezolizumab) and Bristol-Myers's Abraxane (nab-paclitaxel) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).
Out of 43 patients enrolled and 38 evaluable, 86.8% (33/38) of evaluable patients demonstrated tumor reduction while disease control rate (DCR) stood at 84.2% (32/38) for all patients.
DCR reached 91.7% (11/12) and 78.2% (18/23) for those with PD-L1 negative and positive tumors, respectively. The most common TEAEs included nausea (51.2%) and fatigue (48.8%) with no Grade 5 hepatic AEs.
One patient had permanently discontinued the study due to an elevated liver function test.
Q2 Earnings: Concurrently, the Company released Q2 2021 financials and estimated its FY2021 net loss to be $40M – $50M indicating around +11.1% Y/Y.
The cash balance stood at $97.3 million to fund eganelisib development.
Price Action: INFI shares are down 29.5% at $1.57 during the market session on the last check Tuesday.
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