Efficacy
Activity in the CNS

Two-Thirds of Patients in the
90180-mg Arm Achieved
an Intracranial Response

 

 

  • At the 8-month median follow-up, among the 23 patients who exhibited an intracranial response, 78% of patients in the 90-mg arm and 68% of patients in the 90180-mg arm maintained a response for at least 4 months

Unless otherwise specified, all results are IRC assessed.


In the 90180-mg arm...

67%
INTRACRANIAL ORR
(0 CR, 67% PR)
(12/18; 95% CI: 41-87)

of patients with measurable (≥10 mm in longest diameter) brain metastases at baseline achieved an intracranial response

In the 90-mg arm...

42% intracranial ORR (11/26; 95% CI: 23-63) at 90 mg once daily (7.7% CR, 35% PR)

 

Median Duration of Intracranial Response
with measurable (≥10 mm) brain metastases at baseline

aThe median duration of follow-up was 8 months (range: 0.1-20.2).
bMedian follow-up for patients with brain metastases was 17.7 months (range: 0.1-32).
c180 mg once daily with a 7-day lead-in at 90 mg once daily.
dOnce-daily dosing.

Duration of intracranial response was measured from date of first intracranial response until intracranial disease progression (new lesions, intracranial target lesion diameter growth ≥20% from nadir, or unequivocal progression of intracranial nontarget lesions) or death.

 

Additional Outcomes

Median Intracranial Progression-Free Survival
with any brain metastases, measurable and/or nonmeasurable

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

PFS was a prespecified endpoint.

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.

aThe median duration of follow-up was 8 months (range: 0.1-20.2).
b180 mg once daily with a 7-day lead-in at 90 mg once daily.
cOnce-daily dosing.

CI, confidence interval; CNS, central nervous system; CR, complete response; IRC, Independent Review Committee; NE, not estimable; NR, not reached; PFS, progression-free survival; PR, partial response.

References: 1. Ahn M-J, Camidge DR, Tiseo M, et al. Oral presentation presented at: IASLC 18th World Conference on Lung Cancer; October 15-17, 2017; Yokohama, Japan. Abstract 8027. 2. Kim D-W, Tiseo M, Ahn M-J, et al. J Clin Oncol. 2017;35(22):2490-2498.

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