Efficacy (ORR and DoR)*

DACOPLICE^® extended the median DoR by 6.5 months versus gefitinib¹

Adapted from Wu YL, et al. Lancet Oncol. 2017.

Improving median DoR versus gefitinib¹

• 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 assessed³
   
• DACOPLICE^® demonstrated an ORR of 75% versus 72% with gefitinib (P = 0.4234, not statistically significant)^1,†
   
• In patients who responded, DACOPLICE® demonstrated a significant median DoR versus gefitinib, 14.8 months versus 8.3 months, respectively (P<0.0001)¹

Maximum tumour change from baseline by BOR (ITT population)^1,II

Adapted from Wu YL, et al. Lancet Oncol. 2017.

Each bar represents an individual patient’s maximum reduction in target lesion size, and dashed lines show cut-offs for progressive disease (≥20% increase) and partial response (≥30% reduction).¹
*ORR and DoR were secondary outcome measures.^1 
†Two-sided Pearson’s χ² test. Not statistically significant.^1
‡Calculated using the Kaplan-Meier method from time of the first documented response until date of progression or the last RECIST assessment for patients who did not have disease progression.^1
§Two-sided Cochran-Mantel-Haenszel test, stratified by EGFR mutation status at randomisation (exon 19 deletion vs. Leu858Arg mutation) and by race (Japanese vs. Chinese and other East Asian vs. non-Asian).^1 
IIPer RECIST version 1.1, by IRC review. Indeterminate was defined as progression not documented within 12 weeks after start of treatment date and where none of the other categories were applicable (complete response, partial response, stable disease or progressive disease).¹

BOR, best overall response; CI, confidence interval; DoR, duration of response; EGFR, epidermal growth factor receptor; HR, hazard ratio; IRC, independent radiological central; ITT, intention-to-treat; ORR, objective response rate; OS, overall survival; RECIST, Response Evaluation Criteria in Solid Tumours.

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