- Lefamulin is noninferior to moxifloxacin for oral treatment of community-acquired bacterial pneumonia (CABP); both agents achieved a 90% clinical response.
Why this matters
- New antibacterials are needed for CABP because of growing antibacterial resistance.
- Phase 3 LEAP 2 multicenter noninferiority randomised controlled trial (n=738), with noninferiority margin set at 10%.
- Doses: oral lefamulin (600 mg every 12 hours for 5 days) vs moxifloxacin (400 mg every 24 hours for 7 days).
- FDA coprimary outcome: early clinical response at 96 hours (within a 24-hour window) after first dose.
- Clinical response was defined as alive, showing improvement in ≥2 of the 4 CABP symptoms, having no worsening of any CABP symptom, and not receiving any nonstudy antibacterial for current CABP episode.
- Funding: Nabriva Therapeutics.
- Lefamulin achieved similar rates of clinical response (90.8%) to moxifloxacin (90.8%; difference, 0.1%; 1-sided 97.5% CI, −4.4% to infinity).
- Lefamulin yielded similar rates of investigator assessment of clinical response at test of cure (coprimary outcome set by European Medicines Agency) in the modified intent-to-treat population (87.5% vs 89.1%; difference −1.6%; 1-sided 97.5% CI, −6.3% to infinity).
- Lefamulin resulted in a higher rate of adverse events (32.6% vs 25.0%), especially gastrointestinal adverse effects.
- Exclusion criteria may limit generalisability.