Efficacy (mOS)

OS in the ITT population

DACOPLICE^® demonstrated an mOS of 34.1 months in the ARCHER 1050 study^2,*

mOS in the ITT population^2,*^,†

Adapted from Mok TS, et al. Presented at ESMO. 2019.⁴

According to the hierarchical testing approach, the analysis was stopped with the testing of ORR as the statistical significance was not reached. Therefore, the statistical significance of OS improvement could not be formally assessed.³

In a descriptive analysis, DACOPLICE^® demonstrated an mOS of 34.1 months versus 27 months with gefitinib (HR = 0.748 [95% CI, 0.591-0.947]).²

OS in the Asian population

DACOPLICE^® is the first EGFR TKI to demonstrate a survival benefit in Asian patients¹

OS in the Asian population^2,‡

Adapted from Mok TS, et al. Presented at ESMO. 2019.⁴

In a subgroup analysis, DACOPLICE^® demonstrated an improvement in mOS of 8.6 months versus gefitinib in Asian patients: 37.7 months versus 29.1 months.^2,‡

Subgroup analysis

DACOPLICE^® demonstrated a significant improvement in OS in key subgroups, including Asian and exon 21 L858R mutation patient populations^2,3

Subgroup analysis of OS (ITT population)^2,‡

Adapted from Mok TS, et al. Presented at ESMO. 2019.⁴

In the ARCHER 1050 study, DACOPLICE^® demonstrated a significant improvement in OS across multiple populations:

• ITT population^2,§
• Asian population²
• Patients with the EGFR exon 21 L858R substitution^1-3

OS in the exon 21 substitution population
 

Patients with EGFR exon 21 L858R substitution experience proven results with DACOPLICE^®1-3

OS in the exon 21 L858R substitution population^2,‡,¶,**

Adapted from Mok TS, et al. Presented at ESMO. 2019.⁴

DACOPLICE^® has proven clinical activity against the common EGFR exon 21 L858R substitutions.^1-3

In a subgroup analysis, DACOPLICE^® demonstrated a significant improvement in OS versus gefitinib in patients with exon 21 L858R substitution.^2,‡,¶

DACOPLICE^® demonstrated a prolongation in mOS of 9.2 months versus gefitinib in patients with exon 21 L858R substitution: 32.5 months versus 23.2 months.^2,‡,¶

OS in the exon 19 deletion population

DACOPLICE^® confers benefit in EGFR-mutant positive patients with exon 19 deletion versus gefitinib¹

OS in the exon 19 deletion population^2,‡,¶,**

Adapted from Mok TS, et al. Presented at ESMO. 2019.⁴

DACOPLICE^® has proven clinical activity against the common EGFR exon 19 deletion.^1-3

In a subgroup analysis, DACOPLICE^® conferred a benefit in OS versus gefitinib in patients with exon 19 deletion: 36.7 months versus 30.8 months (HR = 0.847** [95% CI, 0.618-1.161]; P = 0.3021).^4,‡,¶,**

*OS was a secondary outcome measure in the ARCHER 1050 study.^1,2 
†Data cut-off: 13 May 2019. Median follow-up time for the OS analysis was 47.9 months.^4
‡The subgroup analyses were not adjusted for multiple testing and were not adequately powered by study design. Subgroup analyses of PFS per IRC review and OS based on pre-specified baseline characteristics were consistent with those from the primary analysis of PFS and OS.^1
§According to the hierarchical testing approach, the analysis was stopped with the testing of ORR as the statistical significance was not reached. Therefore, the statistical significance of OS improvement could not be formally assessed.^3
||P interaction.^4
¶OS is based on an ad hoc analysis with extended follow-up of median of 47.9 months approximately 2 years from the predesignated final analysis. The most recent cut-off of 13 May 2019.¹
**Unstratified analysis.⁴

ARCHER, Adolescent Rural Cohort on Hormones, Education, Environment, Health and Relationships; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; EGFR, epidermal growth factor receptor; HR, hazard ratio; IRC, independent radiological central; ITT, intention-to-treat; mOS, median overall survival; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; TKI, tyrosine kinase inhibitor.
 

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