SYSTEMIC EFFICACY

Doubled Median PFS vs Crizotinib (ITT Population)

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

Kaplan-Meier Plot of PFS

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

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
  • At the data cutoff of IA2, 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.

 
 

In the final analysis with 40.4 months of median follow-up, the 3-year PFS rate was 43% (95% CI: 34, 51) with ALUNBRIG and 19% (95% CI: 12, 27) with crizotinib2

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

The median DOR with ALUNBRIG was 33.1 months (95% CI: 22.0, NE)3

  • The median DOR was 13.8 months (95% CI: 10.4, 20.8) for crizotinib3

The ORR analysis was consistent with the results of the second interim analysis2

  • Confirmed ORR: 74% (n=102/137; 95% CI: 66, 82) with ALUNBRIG vs 62% (n=86/138; 95% CI: 54, 70) with crizotinib; P=0.0330

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.

Final analysis with 40.4 months of median follow‑up2

Overall Survival Was Assessed in All Patients, Including Those With Brain Metastases at Baseline2

Median Overall Survival Not Reached for Both Arms3

  • 30% of patients (n=41/137) died in the ALUNBRIG arm vs 37% of patients (n=51/138) in the crizotinib arm3
  • The 3-year OS rate was 71% (95% CI: 62, 78) with ALUNBRIG and 68% (95% CI: 59, 75) with crizotinib (HR=0.81; 95% CI: 0.53, 1.22; P=0.331)2

 

CI, confidence interval; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; IA2, second interim analysis; ITT, intent to treat; NE, not estimable; ORR, overall response rate; OS, overall survival; PFS, progression-free survival.

References

1. Camidge DR, Kim HR, Ahn MJ, et al. J Clin Oncol. 2020;38(31):3592-3603. 2. Camidge DR, Kim HR, Ahn MJ, et al. J Thorac Oncol. 2021. doi:10.1016/j.jtho.2021.07.035. 3. Alunbrig. Prescribing information. Takeda Pharmaceuticals America, Inc; 2022.

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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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