ARIKAYCE + background regimen achieved significantly greater culture conversion rates1,2

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In adult patients with refractory MAC lung disease,
ARIKAYCE + background regimen achieved significantly greater culture conversion rates1,2

29.0% vs 8.9% graphic

There was over a 3-fold increase in the percentage of patients who achieved the primary endpoint of culture conversion by Month 6 (29% [65/224]) compared to those who received the background regimen alone (8.9% [10/112]) (P<0.0001).1,2

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

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

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Sputum culture results and true microbiologic status

A recently published analysis of sputum samples from the randomized, double-blind, placebo-controlled, Phase 2 trial (INS-112) of ARIKAYCE showed that negative sputum culture results for MAC isolates during treatment with amikacin reliably reflected the true microbiologic status of the patient. Culture results of sputum-containing M avium isolates were not influenced by the presence of amikacin.5

In addition, processing of sputum samples involves dilution and centrifugation, which separates the cellular material to be cultured from soluble elements, such as residual amikacin.1,5

The first negative culture had to be achieved by Month 4 to meet the primary endpoint1,2

Icon of 3 petri dishes with checkmarks, the first of which is highlighted.

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

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.1,2

Cumulative proportion of patients achieving culture conversion shown by the first month of conversion1

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In the ARIKAYCE (amikacin liposome inhalation suspension) + background regimen arm (n=224) vs the background regimen alone arm (n=112), respectively: 4.9% vs 5.4% of patients achieved culture conversion by baseline; 15.2% vs 8.0% were converters by Month 1; 23.7% vs 8.9% were converters by Month 2; 27.2% vs 8.9% were converters by Month 3; and 29.0% vs 8.9% were converters by Month 4.

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

Footnote

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.1,3,4

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 at Month 6. The date of conversion was defined as the date of the first of 3 negative monthly cultures.1,2

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In a post-hoc analysis,
95.4% of converters sustained culture conversion in the CONVERT trial through Month 63

When evaluating all trial patients, 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

  • To be considered a converter, patients needed to achieve their first negative sputum culture by Month 4 or earlier1,2
  • In the CONVERT trial, 65 patients in the ARIKAYCE + background regimen arm and 10 patients in the background regimen alone arm were converters1
  • Out of these converters, 62 patients in the ARIKAYCE + background regimen arm remained culture negative through Month 6 compared to 7 patients on background regimen alone in a post-hoc analysis3

Durability of culture conversion through Month 61,3

Results for durability of culture conversion in the CONVERT trial showed that of the 65 converters in the ARIKAYCE (amikacin liposome inhalation suspension) + background regimen arm, 62 patients (or 95.4%) sustained culture conversion through Month 6. Of the 10 converters in the background regimen alone arm, 7 patients (or 70%) sustained culture conversion through Month 6. Results for durability of culture conversion in the CONVERT trial showed that of the 65 converters in the ARIKAYCE (amikacin liposome inhalation suspension) + background regimen arm, 62 patients (or 95.4%) sustained culture conversion through Month 6. Of the 10 converters in the background regimen alone arm, 7 patients (or 70%) sustained culture conversion through Month 6.

Patients with sustained culture conversion started converting by Month 4 or earlier and maintained monthly negative cultures through Month 6 of the trial.1-3

Footnote

A post-hoc analysis showed that 3 patients in each treatment arm who initially achieved culture conversion did not have sustained sputum culture conversion through Month 6.1

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The CONVERT trial evaluated patients with refractory MAC lung disease.1

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Trial design icon

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.1-3

Footnote

*The CONVERT trial is referred to as “Trial 1” in the ARIKAYCE full Prescribing Information.

6MWT=6-minute walk test; ATS=American Thoracic Society; IDSA=Infectious Diseases Society of America; MAC=Mycobacterium avium complex; NTM=nontuberculous mycobacteria; SGRQ=St George's Respiratory Questionnaire.

References

  1. ARIKAYCE [package insert]. Bridgewater, NJ: Insmed Incorporated; 2018.
  2. Griffith DE, Eagle G, Thomson R, et al. 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. Data on file. Insmed Incorporated. Bridgewater, NJ.
  4. Griffith DE, Eagle G, Thomson R, et al. 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. https://www.atsjournals.org/doi/suppl/10.1164/rccm.201807-1318OC. Accessed January 2, 2019.
  5. Eagle G, Brown K, Floto RA. Examining the effect of residual amikacin on sputum culture for nontuberculous mycobacteria. Am J Respir Crit Care Med. 2018;197(2):267-269.