SYSTEMIC EFFICACY

ALUNBRIG® (brigatinib) Extended Progression-Free Survival (PFS) Twofold vs crizotinib (ITT Population)

Major Efficacy Outcome Measure: PFS as Assessed by a Blinded Independent Review Committee (BIRC)

Kaplan-Meier Plot of PFS Showed an Early and Sustained Clinical Benefit in Favor of ALUNBRIG

Kaplan-Meier Plot of PFS Showed an Early and Sustained Clinical Benefit in Favor of ALUNBRIG

aStratified by presence of brain metastases at baseline and prior chemotherapy for locally advanced or metastatic disease for log-rank test and Cochran Mantel-Haenszel test, respectively.

Additional Study Results: PFS

Investigator-Assessed PFS

  • 29.4 months PFS for ALUNBRIG vs 9.2 months for crizotinib (HR=0.43; 95% CI: 0.31, 0.61)1,b

PFS at 2 Years (BIRC-Assessed)

  • 48% for ALUNBRIG vs 26% for crizotinib (56% vs 24%, respectively, assessed by investigators)1,b

In post hoc analyses, BIRC-assessed PFS results were consistent across subgroups, including age, sex, race, smoking status, ECOG performance, brain metastases (present or absent), and prior chemotherapy (yes or no).1

Study Limitation: ALTA 1L was not powered to detect differences across subgroups.

ALUNBRIG Delivered High Response Rates and Durable Responses (ITT Population)

The Confirmed Overall Response Rate Was Significantly Higher for ALUNBRIG vs crizotinib

ALUNBRIG Delivered High Response Rates and Durable Responses (ITT Population)

Median Duration of Response

  • At the 25-month follow-up,1 the median duration of response had not been reached for ALUNBRIG (95% CI: 19.4, NE) vs 13.8 months for crizotinib (95% CI: 9.3, 20.8)

Response Rate ≥24 months: 51% for ALUNBRIG vs 30% for crizotinib

At the data cutoff, overall survival data were not mature.

aStratified by presence of brain metastases at baseline and prior chemotherapy for locally advanced or metastatic disease for log-rank test and Cochran Mantel-Haenszel test, respectively.

bInvestigator-assessed PFS did not include a formal hypothesis test with Type I error control. In addition, ALTA-1L was an open-label trial so there may be bias that contributed to the estimation of benefit from the investigator-assessed PFS.

 

ALK+, anaplastic lymphoma kinase-positive; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; ITT, intention to treat; NE, not estimable; NSCLC, non-small cell lung cancer.

 
 


 

Reference

  1. Camidge DR, Kim HR, Ahn MJ, et al. J Clin Oncol. 2020; available at: https://www.ascopubs.org/doi/full/10.1200/JCO.20.00505. Accessed August 13, 2020.

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In Vitro: ALUNBRIG Inhibited 17
ALK-Inhibitor-Resistant Mutations1,2

ALUNBRIG exhibited in vivo antitumor activity against 4 mutant forms of EML4-ALK, including the G1202R and L1196M mutants identified in NSCLC tumors in patients who had progressed on crizotinib.


 

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