Systemic Efficacy

More Than Half of Patients Taking ALUNBRIG® (brigatinib) Achieved a Robust Response at the Recommended Dosing Regimena

ORRs in the
90180-mg arma (n=110)

CI, confidence interval; CR, complete response; PR, partial response; IRC, Independent Review Committee; ORR, overall response rate.

Additional Study Results

ORR for the 90-mg armb (n=112)

  • 48% (95% CI: 39-58) ORR by IRC assessment (3.6% CR, 45% PR)
  • 45% (95% CI: 35-54) by Investigator assessment (0.9% CR, 44% PR)

a180 mg once daily with 7-day lead-in at 90 mg once daily.
bOnce-daily dosing.

 

 

ALUNBRIG Delivered a Durable Response

Median Duration of Response (mDOR) for the 90180-mg arma (n=110)

Follow-up results were presented at the 54th Annual Meeting of the American Society of Clinical Oncology in June 2018.

a180 mg once daily with a 7-day lead-in at 90 mg once daily.
bThe median duration of follow-up was 8 months (range: 0.1-20.2).
cMedian (range) follow-up: 19.6 (0.1–35.2) months in the 90-mg arm and 24.3 (0.1–39.2) months in the 90180-mg arm.
dOnce-daily dosing.

IA, Investigator assessed; NE, not estimable.

 

 

Additional Outcomes

Median Progression-Free Survival (mPFS) for the 90180-mg arma

Study limitations: ALTA was not a controlled trial and not prospectively designed for statistical comparisons between dosing arms.

PFS was a prespecified endpoint.

Follow-up results were presented at the 54th Annual Meeting of the American Society of Clinical Oncology in June 2018.

ALTA Study Design: The safety and efficacy of ALUNBRIG were evaluated in a global, two-arm, open-label, multicenter trial. The trial consisted of 222 adult patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib. Patients were randomized to receive the recommended dosing regimen of 180 mg of ALUNBRIG orally once daily with a 7-day lead-in at 90 mg once daily (n=110, 18 with measurable brain metastases ≥10 mm in longest diameter at baseline), or 90 mg of ALUNBRIG orally once daily (n=112, 26 with measurable brain metastases ≥10 mm in longest diameter at baseline). The major efficacy outcome measure was confirmed objective response rate (ORR) according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1) as evaluated by an Independent Review Committee (IRC). Additional efficacy outcome measures included Investigator-assessed ORR, duration of response (DOR), intracranial ORR, and intracranial DOR.

 

a180 mg once daily with a 7-day lead-in at 90 mg once daily.
bMedian (range) follow-up: 19.6 (0.1–35.2) months in the 90-mg arm and 24.3 (0.1–39.2) months in the 90180-mg arm.
cMedian PFS at the 8-month follow-up: 15.6 months (95% CI: 11.0-NR) by IRC assessment and 12.9 months (95% CI: 11.1-NR) by Investigator assessment for the 90180-mg group; and 9.2 months (95% CI: 7.4-NR) by IRC assessment and 9.2 months (95% CI: 7.4-15.6) by Investigator assessment for the 90-mg group.2
dOnce-daily dosing.

References: 1. Huber RM, Kim D-W, Ahn M-J, et al. Poster presented at: the 54th Annual Meeting of the American Society of Clinical Oncology; June 1-5, 2018; Chicago, IL. Poster 384 (Abstract 9061). 2. Kim D-W, Tiseo M, Ahn M-J, et al. J Clin Oncol. 2017;35(22):2490-2498.

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