Phase III CONVERT study of amikacin liposome suspension in nontuberculous mycobacterial lung disease published in AJRCCM.- Insmed.

Insmed Incorporated announced that data from the pivotal Phase III CONVERT study evaluating the safety and efficacy of ALIS (amikacin liposome inhalation suspension) in adult patients with treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) were published online in the American Journal of Respiratory and Critical Care Medicine. The study showed that the addition of ALIS to guideline-based therapy (GBT) eliminated evidence of NTM lung disease caused by MAC in sputum cultures by Month 6 in 29.0% of patients (65/224), compared to 8.9% of patients (10/112) on GBT alone. In the study, rates of serious treatment-emergent adverse events were similar between treatment arms (20.2% for ALIS+GBT vs. 17.9% for GBT alone). Overall the rate of reported adverse events in the ALIS plus GBT arm was higher (98.2% for ALIS+GBT vs. 91.1% for GBT alone).

TEAEs led to discontinuation of ALIS in 17.4% of patients. The most common TEAEs (occurring in at least 10% of patients) were primarily respiratory events and were predominately mild or moderate in nature. Most of these common events were initially reported in the first month of ALIS treatment and infrequently led to discontinuation of ALIS (dyspnea, 3.1%; dysphonia, 2.2%; all others less than 1%) or withdrawal from the study. Side effects commonly associated with intravenous use of amikacin, including hearing loss or renal impairment, were infrequent and generally similar between treatment groups with the exception of tinnitus (7.6% for ALIS+GBT vs. 0.9% for GBT alone).

See: "Amikacin Liposome Inhalation Suspension for Treatment-Refractory Lung Disease Caused by Mycobacterium avium Complex (CONVERT): A Prospective, Open-Label, Randomized Study." David E Griffith et al. American Journal of Respiratory and Critical Care Medicine September 14, 2018 as DOI: https://doi.org/10.1164/rccm.201807-1318OC