Investigational Antibiotic Combo Beats Best Available Tx for CRE
The Medicines Company announced new data from an interim analysis of the TANGO-2 trial evaluating meropenem-vaborbactam (Vabomere), a combination antibiotic, for the treatment of carbapenem-resistant Enterobacteriaceae (CRE) infections of blood, lung, urinary tract, and abdominal organs. Vabomere was previously referred to as Carbavance.
The Phase 3, multi-center, randomized, open-label TANGO-2 trial evaluated meropenem-vaborbactam vs. best available therapy in patients with serious infections (eg, bacteremia, hospital-acquired or ventilator-associated bacterial pneumonia, complicated intraabdominal infections) suspected or due to CRE.
Patient randomization was discontinued early after an independent Data and Safety Monitoring Board (DSMB) determined that a risk-benefit analysis (n=72) of available data no longer necessitated additional patient randomization to the comparator arm (best available therapy). The recommendation came from the interim data that showed statistically significant differences in efficacy for meropenem-vaborbactam vs. best available therapy, as measured by clinical cure at the test of cure visit in the specified primary population.
The meropenem-vaborbactam arm exhibited lower rates of mortality, renal adverse events, and serum creatinine increases compared to those treated with best available therapy (eg, colistin, aminoglycosides).
Vabomere is an investigational, fixed-dose combination of meropenem, a carbapenem, and vaborbactam, a novel beta-lactamase inhibitor. Vabomere was designated as a Qualified Infectious Disease Product (QIDP) and was granted Fast Track status by the Food and Drug Administration (FDA).
The study is continuing to enroll patients into a modified single-arm study design for treatment with meropenem-vaborbactam at select locations. Findings from TANGO-2 are expected to be presented at a future medical conference and published in a peer-reviewed publication.
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