In adult patients with refractory MAC lung disease,
Culture conversion results that last 15+ months1-3


Nearly one-third of refractory patients culture converted by Month 6 and over half stayed converted1-3

Primary and Secondary Charts

aP<0.0001 vs standard therapy.


In the CONVERT trial, the endpoints of the change from baseline in 6MWT distance and SGRQ did not demonstrate clinical benefit at Month 6.1

CONVERT study design


The efficacy and safety of ARIKAYCE + standard therapy vs standard therapy alone were evaluated in an open-label, randomized (2:1), multicenter, global, Phase 3 trial of 336 adult patients with refractory MAC lung disease.1,2

Primary endpoint1,2

Patients who culture converted by Month 6. Patients needed to achieve their first negative culture by Month 4 to meet the primary endpoint. Culture conversion was defined as 3 consecutive monthly negative sputum cultures. The study design required 2 or 3 negative sputum samples per month for 3 consecutive months to confirm culture conversion.

Secondary/exploratory endpoints2,3

Patients who remained culture converted 12 months after initial conversion, and 3 and 12 months after treatment ended, along with change from baseline in 6MWT and SGRQ.

Patients were considered to have refractory MAC lung disease if they did not achieve negative sputum cultures after a minimum duration of 6 consecutive months of standard therapy that was either ongoing or had been stopped no more than 12 months before the screening visit.1

Patient selection in the CONVERT trial

Key inclusion criteria4

  • MAC lung disease documented by at least 2 positive cultures (≥1 positive culture within 6 months prior to screening and 1 positive culture at screening with cultures obtained ≥1 month apart)
  • Did not respond to active therapy for ≥6 months. Treatment was either ongoing or had been stopped no more than 12 months before the screening visit
  • Evidence of underlying lung disease, such as nodular bronchiectasis and/or fibrocavitary disease by chest radiography or CT

Key exclusion criteria4

  • Cystic fibrosis
  • MAC lung disease resistant to amikacin (as identified by MIC susceptibility >64 μg/mL)
  • Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within 1 year before screening or anticipated during study period
  • Acquired and primary immunodeficiency syndrome (eg, HIV-positive patients regardless of CD4 counts)

Key baseline patient characteristics in the CONVERT trial2,5

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Key baseline patient characteristics in the convert trial
Key baseline patient characteristics in the convert trial
Parameter ARIKAYCE + standard therapy (n=224)
n (%)
Standard therapy alone (n=112)
n (%)
Gender
Female 165 (73.7) 68 (60.7)
Male 59 (26.3) 44 (39.3)
Underlying lung disease
Bronchiectasis only 146 (65.2) 64 (57.1)
COPD‡ 29 (12.9) 19 (17.0)
COPD‡ and bronchiectasis 22 (9.8) 18 (16.1)
Standard therapy prior to enrollment
On treatment 201 (89.7) 101 (90.2)
Off treatment for at least 3 months 23 (10.3) 11 (9.8)

Summary of standard therapy in the CONVERT trial at baseline


Standard therapy was composed of an antimycobacterial regimen of at least 2 antibiotics based on the 2007 ATS/IDSA Statement or respective local guidelines. These drugs may have included, but were not limited to, azithromycin, clarithromycin, clofazimine, ethambutol, ethionamide, rifabutin, and rifampicin.2,4-6




% of patients with ≤2 or ≥3 drugs in regimen4

of patients with 2 or 3 drugs in regimen 4

ARIKAYCE + standard therapy (n=223)

Standard therapy alone (n=112)

AFTER 6 MONTHS OF TREATMENT FAILURE FOR MAC LUNG DISEASE,
Choose to add ARIKAYCE for your patients1

See MAC inside

Using your smart device, scan the QR code to get an inside view of a MAC lung infection in augmented reality (AR).

Footnotes

*There was up to a 10-week window between screening and baseline during which time some patients may have achieved their first negative sputum culture. At the time of enrollment, 89.9% (302/336) of patients were either on a guideline-based regimen for MAC, or off guideline-based therapy for MAC for less than 3 months.1,4,5

Culture conversion by Month 6 was a surrogate endpoint.1 Clinical benefit has not yet been established.

COPD was derived from the medical history data.2

§Additional management strategies are not included in the ARIKAYCE full Prescribing Information. The data are from a telephone survey of 26 patients prescribed ARIKAYCE conducted during a 2-month period at 2 academic medical centers in the United States. Writing assistance was provided to the authors through funding from Insmed Incorporated. Insmed was not involved with the conceptualization, development, conduct, or analyses of the survey.8

6MWT=6-minute walk test; ATS=American Thoracic Society; CT=computed tomography; HIV=human immunodeficiency virus; IDSA=Infectious Diseases Society of America; ITT=intent to treat; IV=intravenous; MIC=minimum inhibitory concentration; SGRQ=St George's Respiratory Questionnaire.

References:
1. ARIKAYCE [package insert]. Bridgewater, NJ: Insmed Incorporated; 2020. 2. Griffith DE, Eagle G, Thomson R, et al; CONVERT Study Group. Amikacin liposome inhalation suspension for treatment-refractory lung disease caused by Mycobacterium avium complex (CONVERT): a prospective, open-label, randomized study. Am J Respir Crit Care Med. 2018;198(12):1559-1569. 3. Griffith DE, Thomson R, Flume PA, et al. Amikacin liposome inhalation suspension for refractory MAC lung disease: sustainability and durability of culture conversion and safety of long-term exposure [published online ahead of print April 19, 2021]. Chest. doi:10.1016/j.chest.2021.03.070. 4. Griffith DE, Eagle G, Thomson R, et al; CONVERT Study Group. Amikacin liposome inhalation suspension for treatment-refractory lung disease caused by Mycobacterium avium complex. Online data supplement. Am J Respir Crit Care Med. 2018;198(12)(suppl):E1-E28. Accessed June 4, 2021. https://www.atsjournals.org/doi/suppl/10.1164/rccm.201807-1318OC/suppl_file/griffith_data_supplement.pdf. 5. Data on file. Insmed Incorporated. Bridgewater, NJ. 6. Griffith DE, Aksamit T, Brown-Elliott BA, et al; ATS Mycobacterial Diseases Subcommittee. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007;175(4):367-416. 7. Daley CL, Iaccarino JM, Lange C, et al. Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline. Clin Infect Dis. 2020;71(4):e1-e36. 8. Swenson C, Lapinel NC, Ali J. Clinical management of respiratory adverse events associated with amikacin liposome inhalation suspension: results from a patient survey. Open Forum Infect Dis. 2020:7(4). doi.org/10.1093/ ofid/ofaa079.

ARIKAYCE + standard therapy (n=224)

Standard therapy alone (n=112)

Responder analysis

Purple Lung

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Culture conversion results through 15 months1-3
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Primary endpoint: Culture conversion by 6 months1,2
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Responder analysis/secondary endpoints: Percentage of patients who met the primary endpoint and remained culture negative1,3

The proportion of the ITT population (224 for ARIKAYCE + standard therapy vs 112 for standard therapy alone) who remained culture negative for 12 months after initial conversion, 3 months after treatment ended, and 12 months after treatment ended was 18.3%, 16.1%, and 13.4% for ARIKAYCE + standard therapy vs 2.7%, 0% and 0% for standard therapy alone, respectively.1,2

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% of patients with ≤2 or ≥3 drugs in regimen4
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