INTRACRANIAL EFFICACY

POST HOC SUBGROUP ANALYSIS: PATIENTS WITH BRAIN METASTASES AT BASELINE

The Median PFS Was Longer With ALUNBRIG® (brigatinib) vs Crizotinib1,2

Kaplan-Meier Plot of PFS

Kaplan-Meier Plot of PFS

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

Absolute Risk Reduction

  • 23% absolute risk reduction; 50% event rate (20/40) for patients taking ALUNBRIG vs 73% event rate (30/41) for patients taking crizotinib1,2

SUBGROUP ANALYSIS: PATIENTS WITH MEASURABLEa BRAIN METASTASES AT BASELINE

The Intracranial Response Rate Was 3 Times Higher With ALUNBRIG vs Crizotinib

Confirmed Intracranial Overall Response Rates

Confirmed Intracranial Overall Response Rates Confirmed Intracranial Overall Response Rates

BIRC-assessed confirmed intracranial ORR and intracranial DOR according to RECIST v1.1 in the subgroup of 41 patients with measurable brain metastases at baseline

Median Duration of Intracranial Responseb

  • 64% of responders achieved an intracranial response duration ≥24 months with ALUNBRIG vs NE for crizotinib

a≥10 mm in longest diameter (at baseline).

bDuration 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.

Final analysis with 40.4 months of median follow-up3

POST HOC SUBGROUP ANALYSIS: PATIENTS WITH BRAIN METASTASES AT BASELINE

ALUNBRIG Reduced the Risk of Death by 57% vs Crizotinib3

Kaplan-Meier Plot of Overall Survival3

Kaplan-Meier Plot of Overall Survival

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

Crossover to ALUNBRIG was allowed upon progression on crizotinib. At the time of the final analysis, 47% (n=65/138) of patients in the crizotinib arm crossed over to receive ALUNBRIG.3


 

BIRC, Blinded Independent Review Committee; CI, confidence interval; DOR, duration of response; HR, hazard ratio; NE, not estimable; ORR, overall response rate; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors.

References

1. Camidge DR, Kim HR, Ahn MJ, et al. J Clin Oncol. 2020;38(31):3592-3603. 2. Takeda Pharmaceuticals U.S.A., Inc. Data on file. 3. Camidge DR, Kim HR, Ahn MJ, et al. J Thorac Oncol.doi:10.1016/j.jtho.2021.07.035.

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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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