In adult patients with refractory MAC lung disease

Significantly more patients achieved culture
conversion by Month 61

In the CONVERT trial, the proportion of patients who achieved culture conversion by Month 6 was significantly greater in the ARIKAYCE + background regimen arm vs the background regimen alone arm1

29.0% vs 8.9%

The percentage of patients who achieved the primary endpoint of culture conversion by Month 6 (29.0% [65/224]) was significantly greater than those who received the background regimen alone (8.9% [10/112]) (P<0.0001).1,2

Culture conversion defined icon

Culture conversion defined

Culture conversion was defined as 3 consecutive monthly negative sputum cultures. In order to meet the primary endpoint at Month 6 of the study, patients would need to achieve their first negative sputum culture by Month 4.1,2

Cumulative proportion of patients achieving culture
conversion shown by the first month of conversion (ITT population)1

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ARIKAYCE multi-drug bar chart

*There was up to a 10-week window between screening and baseline, and some patients achieved their first negative sputum culture at the baseline (Day 1) visit.
Most patients were on a background regimen at screening.2,3

Data up to Month 4 are displayed since patients had to achieve the first of 3 consecutive negative sputum cultures by Month 4 in order to meet the primary endpoint of culture conversion by Month 6. The date of conversion was defined as the date of the first of 3 negative monthly cultures.1,2

95.4% of patients

In a post-hoc analysis, 95.4% (62/65) of converters in the ARIKAYCE + background regimen arm sustained culture conversion by Month 6 compared to 70% (7/10) of converters in the background regimen alone arm.3

27.7% (62/224) of all patients in the ARIKAYCE + background regimen arm and 6.3% (7/112) of all patients in the background regimen alone arm had sustained culture conversion through Month 6.1

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A closer look at the CONVERT clinical trial study population1

The CONVERT trial evaluated patients who were refractory to treatment. Patients were considered to have refractory Mycobacterium avium complex (MAC) lung disease if they did not achieve negative sputum cultures after a minimum duration of 6 consecutive months of background regimen therapy. Treatment was either ongoing or stopped no more than 12 months before the screening visit.

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patient population
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Explore the CONVERT clinical trial1-3

ARIKAYCE was evaluated in an ongoing, open-label, randomized (2:1), multicenter, global, Phase 3 trial of 336 adult patients with refractory MAC lung disease who did not respond to treatment.

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Study Design

ATS=American Thoracic Society; IDSA=Infectious Diseases Society of America; ITT=intent to treat.