An analysis of the efficacy of micafungin in Candida infections caused by non-albicansCandida species in phase III trials

Abstract number: 1733_471

Cornely O.A., De Waele J., Betts R., Rotstein C., Nucci M., Kovanda L., Wu C., Ullmann A.J.

Objective: In recent years, the prevalence of non-albicansCandida species has increased. Some antifungal agents, such as fluconazole, are limited by intrinsic and acquired resistance in non-albicansCandida species. The objective of this study is to evaluate the efficacy of micafungin (MICA) against fungal infections caused by non-albicansCandida species in two comparative phase III trials.

Methods: Two phase III, randomised, multicentre, active-controlled trials conducted in patients with invasive candidiasis/candidaemia were examined to assess the efficacy of MICA in non-albicansCandida infections. Both studies were conducted in adult patients with confirmed Candida infection at baseline. One trial compared MICA at 100 mg/day (MICA100) with liposomal amphotericin B (L-AmB) at 3 mg/kg/day; the other trial compared MICA100 and MICA at 150 mg/day (MICA150) with caspofungin (CAS) at 50 mg/day (70 mg loading dose on Day 1). The primary efficacy endpoint was treatment success at the end of therapy, defined as both positive clinical and positive mycological response as assessed by the investigator.

Results: The primary efficacy population (per protocol set; PPS) of the two-arm trial included 392 patients (MICA100: n = 202; L-AmB: n = 190). In the three-arm trial, the primary efficacy population was the full analysis set (FAS), which included 593 patients (MICA100: n = 191; MICA150: n = 199; CAS: n = 188). The key efficacy results are shown in the table. In the two-arm trial, MICA showed equivalent treatment success rates to L-AmB in all Candida species isolated. A similar result was seen in the three-arm trial, with the two MICA doses being at least as effective as CAS for all species isolated. There were no marked differences in treatment success with MICA between infections caused by C. albicans and those caused by non-albicansCandida species.

Conclusion: MICA demonstrated broad-spectrum efficacy against Candida infections. MICA is a valuable treatment option in invasive candidiasis and candidaemia.