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Clinical Data TANGO 1 Top-Line Results
TANGO 1 is a multi-center, randomized, double-blind, double-dummy Phase 3 study to evaluate the efficacy, safety and tolerability of CARBAVANCE compared to piperacillin-tazobactam in the treatment of cUTI, including acute pyelonephritis, in adults. The trial enrolled 550 adult patients who were randomized 1:1 to receive CARBAVANCE (meropenem 2g-vaborbactam 2g) as a 3-hour IV infusion every 8 hours or piperacillin 4g-tazobactam 500mg as a 30 minute IV infusion every 8 hours, each for up to 10 days. After a minimum of 5 days of IV therapy, patients who met protocol-defined criteria of improvement were transitioned to oral levofloxacin.For the FDA, the primary assessment was performed in the microbiologic modified intent-to-treat (mMITT) patient population, and was defined as overall success of clinical outcome (cure or improvement and microbiologic outcome of eradication (baseline bacterial pathogen reduced to < 104 CFU/ml)). Overall success was observed in 188/192 patients (98.4%) in the meropenem-vaborbactam group and in 171/182 patients (94.0%) in the piperacillin-tazobactam group—a difference of 4.5% (95% CI: 0.7 % to 9.1%).For the EMA, the primary assessment was defined as microbiologic outcome of eradication (baseline bacterial pathogen reduced to < 103 CFU/ml) at the test-of-cure (TOC) visit in the mMITT and microbiologic evaluable (ME) patient populations. For the mMITT patient population, the microbiological eradication was 128/192 patients (66.7%) in the meropenem-vaborbactam group and 105/182 patients (57.7%) in the piperacillin-tazobactam group—a difference of 9.0% (95% CI: -0.9% to 18.7%). For the ME patient population, the microbiological eradication was 118/178 patients (66.3%) in the meropenem-vaborbactam group and 102/169 patients (60.4%) in the piperacillin-tazobactam group—a difference of 5.9% (95% CI: -4.2% to 16%).In the safety population (272 in the meropenem-vaborbactam group; 273 in the piperacillin-tazobactam group), there were 106 patients (39.0%) that reported treatment emergent adverse events (TEAEs) in the meropenem-vaborbactam group and 97 patients (35.5%) that reported TEAEs in the piperacillin-tazobactam group. Drug-related TEAEs were reported with similar frequency in the meropenem-vaborbactam group (15.1% of patients) and the piperacillin-tazobactam group (12.8% of patients). Study drug discontinuation due to adverse events occurred in 7 patients (2.6%) that received meropenem-vaborbactam and 14 patients (5.1 %) that received piperacillin-tazobactam. Serious adverse events (SAEs) occurred in 11 patients (4%) that received meropenem-vaborbactam and 12 patients (4.4%) that received piperacillin-tazobactam. There were 2 deaths in each treatment group.

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