- Lefamulin was noninferior to moxifloxacin in treating community-acquired bacterial pneumonia (CABP), regardless of patient risk.
Why this matters
- If FDA-approved, lefamulin will offer a new class of antibiotic monotherapy for CABP.
- Pooled analysis of results from 2 prospective, double-blind, double-dummy, phase 3 studies randomly assigning patients to 3 days intravenous lefamulin vs moxifloxacin (Lefamulin Evaluation Against Pneumonia [LEAP] 1) or 5 days oral lefamulin (+2 days sham) vs 7 days moxifloxacin (LEAP 2).
- Primary endpoint was early clinical response (ECR) at 96 +/− 24 hours after first dose of study drug in intention-to-treat population.
- Patients in lefamulin (646) and moxifloxacin (643) groups had similar demographics and were predominantly male (55.6%) and white (79%).
- ECR rates in lefamulin (89.3%) and moxifloxacin (90.5%) demonstrated noninferiority across all Pneumonia Outcomes Research Team-defined severities of CABP (pooled rate difference, −1.1 [95% CI −4.4 to 2.2]).
- Treatment-emergent adverse event (TEAE) rates were similar in lefamulin vs moxifloxacin groups (34.9% vs 30.4%).
- The lefamulin group had slightly more serious (5.6% vs 5.0%) and fatal (1.7% vs 1.2%) TEAEs, more infusion site reactions (7.0% vs 2.6%), and more gastrointestinal TEAEs (diarrhea, nausea, and vomiting most common).
- Results may not be generalizable to all demographics.