Background

Dacomitinib, a second-generation, irreversible tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR), provided statistically significant progression-free survival improvement over gefitinib in treatment-naive patients with advanced EGFR mutation–positive non-small cell lung cancer (NSCLC) in a global phase 3 study (ARCHER 1050; NCT01774721). Here, we report interim analysis of ARIA, a non-interventional study of dacomitinib’s real-world (RW) utilization and associated clinical outcomes in Asian patients with advanced EGFR mutation–positive NSCLC.

Methods

This longitudinal, multicenter cohort study collected prospective and retrospective data from patients with advanced EGFR mutation–positive NSCLC who were treated with first-line (1L) dacomitinib based on routine practices and their best interest. Study objectives were to describe patient demographics and clinical characteristics, treatment patterns of dacomitinib use, and RW outcomes of 1L dacomitinib.

Results

300 patients from China (n=262), India (n=24), and Malaysia (n=14) were enrolled and included in the analysis. Starting dose was 30 mg once daily (QD) in 159 patients (53%), 45 mg QD in 138 (46%), and other doses in 3 (1%). As of Jan 31, 2023, 81 patients (27.0%) had dose decreases, 13 (4.3%) dose increases, 35 (11.7%) interruptions, and 107 (35.7%) permanently discontinued dacomitinib. Six (2.0%) permanent treatment discontinuations were due to treatment-related toxicities. 1L dacomitinib safety and treatment outcomes are shown in the table. Table: 1337P

Safety and treatment outcomes of 1L dacomitinib

Conclusions

To our knowledge, this is the largest RW study conducted for dacomitinib. Interim analysis shows efficacy of 1L dacomitinib; safety data in the RW setting were generally consistent with dacomitinib’s known safety profile. These results support 1L dacomitinib use in patients with advanced EGFR mutation–positive NSCLC.

Clinical trial identification

NCT04609319.

Editorial acknowledgement

Medical writing support was provided by Arrianna Carey, PhD, of ClinicalThinking, Inc, and funded by Pfizer.

Legal entity responsible for the study

Pfizer.

Funding

Pfizer.

Disclosure

L. Wu: Financial Interests, Personal, Principal Investigator: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer, AstraZeneca, BMS, MSD, Roche; Financial Interests, Personal, Invited Speaker: Pfizer, AstraZeneca, BMS, MSD, Roche. J. Li: Non-Financial Interests, Institutional, Principal Investigator: Pfizer. C. Xu: Financial Interests, Personal, Invited Speaker: AstraZeneca, Bristol Myers Squibb, MSD, Novartis, Pfizer, Roche, Hengrui Pharmaceutical, BeiGene, Takeda, Burning Rock Biotech, Zhengda Tianqing Pharmaceutical Group, CStone Pharmaceuticals, Innovent Biologics; Financial Interests, Institutional, Research Grant: Hengrui Pharmaceutical, Pfizer. K. Tang: Non-Financial Interests, Institutional, Principal Investigator: The First Affiliated Hospital of Sun Yat-sen University. H. Wang: Non-Financial Interests, Institutional, Principal Investigator: Pfizer. G.F. Ho: Financial Interests, Personal, Advisory Board: Merck & Co., Inc., Novartis, AstraZeneca, Boehringer Ingelheim, Pfizer; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, Pfizer, Merck & Co., Inc., Novartis, Roche, Boehringer Ingelheim, MSD, F. Hoffmann-La Roche AG, Eisai; Financial Interests, Personal, Other, Chairperson: Bristol Myers Squibb; Financial Interests, Institutional, Invited Speaker: Eli Lilly, Regeneron, Merck & Co., Inc., AB Science, Astellas, Tessa Therapeutics, Roche, Arcus Bioscience, AstraZeneca, Pfizer, Janssen Research & Development, Mirati Therapeutics, Novartis, Amgen, Boehringer Ingelheim; Non-Financial Interests, Institutional, Product Samples: Eli Lilly, Janssen Pharmaceuticals, Novartis, Pfizer, Taiho; Non-Financial Interests, Personal, Training: MSD, Ipsen, AstraZeneca, Bristol Myers Squibb, Regeneron Pharmaceuticals, Dr Reddy’s. Y. Lu: Financial Interests, Personal, Advisory Board: Pfizer. M. Zhao: Financial Interests, Personal, Principal Investigator: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Pfizer. L.M. Tho: Non-Financial Interests, Personal and Institutional, Invited Speaker: Pfizer, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Novartis, Merck . J. Zhao: Financial Interests, Personal, Principal Investigator: Pfizer; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Pfizer. S. He: Financial Interests, Personal, Other, Employment: Pfizer. J. Huang: Financial Interests, Institutional, Full or part-time Employment: Pfizer (China) Research and Development Co., Ltd. X. Tang: Financial Interests, Personal, Full or part-time Employment: Pfizer. C.H. Wong: Financial Interests, Institutional, Full or part-time Employment, Employee of Pfizer Inc: Pfizer Inc; Financial Interests, Institutional, Stocks/Shares: Pfizer Inc. Y. Wu: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, Hengrui, Merk, MSD, Pfizer, Roche, Sanofi; Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Takeda; Financial Interests, Coordinating PI: AstraZeneca, Boehringer Ingelheim, BMS, Hengrui, Merk, MSD, Pfizer, Roche, Eli Lilly; Financial Interests, Steering Committee Member: Sanofi, Yunhan; Non-Financial Interests, Leadership Role: Chinese Thoracic Oncology Group (CTONG); Non-Financial Interests, Other, WCLC 2020 Conference Chair: IASLC; Non-Financial Interests, Leadership Role, Past President: Chinese Society of Clinical Oncology (CSCO). All other authors have declared no conflicts of interest.