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Start With Proven First-line Efficacy1-3
Dacomitinib is a kinase inhibitor indicated for the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.3
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
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.
References:
Please click the Prescribing Information link to view the safety and adverse events information of DACOPLICE®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.
PP-DAC-IND-0147 June 2022
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DACOPLICE® is a second-generation EGFR TKI
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ARCHER 1050 study reported the most common adverse events in patients
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https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf , Page No. 39, Rule 2 part (ee), last accessed on 13th September 2019.
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