Efficacy Maintained After Dose Reduction

Overview

Efficacy was maintained in patients whose dose was reduced⁴ 
 

This was a post hoc exploratory analysis. Therefore, the results of this analysis cannot be used to suggest potential increased efficacy in patients whose dose was reduced.⁴

All patients in the Phase III study received a starting dose of 45 mg QD and efficacy comparisons of patients by their lowest dose on study (30 mg QD, 15 mg QD) are not likely to reflect the efficacy for these patients had they started with 30 mg QD or 15 mg QD.^1,4

Adapted from Corral J, et al. Future Oncol. 2019.

Dose reductions occurred in 66% of patients treated with DACOPLICE^®.¹

In the ITT population

Dose reduction of DACOPLICE^® did not compromise OS in the ITT population⁵

• Dose reduction of DACOPLICE^® did not compromise efficacy in the ITT population⁵
    
• OS benefit was maintained in patients who had dose reduction versus all DACOPLICE^® patients: 42.5 months versus 34.1 months, (HR = 0.554 [95% CI, 0.420-0.730])^5,*

Adapted from Mok TS, et al. Presented at ESMO. 2019.⁵ 

Dose reductions occurred in 66% of patients treated with DACOPLICE^®.¹

In the Asian population

In the Asian population, dose reduction of DACOPLICE^® did not compromise the OS⁵

• Dose reduction of DACOPLICE^® does not compromise the OS in the Asian population⁵
   
• The OS benefit was maintained in Asian patients who had dose reduction versus all Asian patients taking DACOPLICE^®: NR versus 37.7 months (HR = 0.543 [95% CI, 0.393-0.750])^5,*,†

OS in all patients on DACOPLICE^® versus those who had a dose reduction^5,*

Adapted from Mok TS, et al. Presented at ESMO. 2019.⁵ 
 

CI, confidence interval; HR, hazard ratio; IRC, independent radiological central; ITT, intention-to-treat; NR, not reached; OS, overall survival; PFS, progression-free survival; QD, once daily.

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