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Dosage Efficacy Interactions Prescribing Information Quality of Life Safety Information Testing and Method of Administration Patient Resource Materials
EfficacyFirst-line XALKORI® (crizotinib) vs chemotherapy in ALK+ advanced NSCLC1
Compared with: chemotherapy followed by any ALK inhibitor; XALKORI® (crizotinib) followed by any other follow-up therapy other than an ALK inhibitor; chemotherapy followed by any other follow-up therapy other than an ALK inhibitor. Retrospective, exploratory analysis of outcomes in patient subgroups (some with small sizes), on the basis of subsequent treatments selected by the investigators (not assigned by randomisation); should be interpreted with caution.2By independent radiologic review.1Stratified log-rank test.1Exploratory analysis.2
Vertical lines on the curve indicate censoring of data.1By independent radiologic review.Adapted from Solomon BJ, et al. N Engl J Med. 20141
Vertical lines on the curve indicate censoring of data.2Exploratory analysis. Median follow-up of approximately 46 months in both arms.Two-sided p-value from the log-rank test stratified by ECOG PS, race, and presence of brain metastases.Patients crossing over from XALKORI® (crizotinib) to chemotherapy received pemetrexed in combination with either cisplatin or carboplatin.
Adapted from Solomon BJ, et al. N Engl J Med. 20182
Vertical lines on the curve indicate censoring of data.Median overall survival in the ITT population was NR (95% CI, 45.8–NR) for patients receiving XALKORI® (crizotinib) (n=172) and 47.5 months (95% CI, 32.2–NR) in patients receiving chemotherapy (n=171) in the PROFILE 1014 study at a median follow-up of approximately 46 months.2Adapted from Solomon BJ, et al. N Engl J Med. 20182
PROFILE 1014: Study design1,3

The first prospective, randomised Phase III trial of an ALK-targeted agent compared to chemotherapy for the first-line treatment of ALK+ advanced NSCLC1

Abbreviations:ALK: anaplastic lymphoma kinase; AUC: area under the curve; BID: twice a day; CI: confidence interval; CNS: Central nervous system; ECOG: Eastern Cooperative Oncology Group; EORTC: European Organisation for Research and Treatment of Cancer; EQ-5D: EuroQol Group 5-Dimensions Self-Report Questionnaire; ESMO: European Society for Medical Oncology; FISH: fluorescence in situ hybridisation; HR: hazard ratio; IC TTP: intracranial time to tumour progression; IRR: independent radiologic review; ITT: intention-to-treat; NR: not reached; NSCLC: non-small cell lung cancer; ORR: objective response rate; OS: overall survival; PFS: progression-free survival; PO: by mouth; PS: performance status; QLQ-C30: Quality of Life Questionnaire - Core 30; QLQ-LC13: Quality of Life Questionnaire – Lung Cancer 13; RECIST: Response Evaluation Criteria in Solid Tumours; TKI: tyrosine kinase inhibitor.References:Solomon BJ, Mok T, Kim DW, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med 2014;371(23):2167-2177.Solomon BJ, Kim DW, Wu YL, et al. Final overall survival analysis from a study comparing first-line crizotinib versus chemotherapy in ALK-mutationpositive non-small-cell lung cancer. J Clin Oncol 2018;36(22):2251-2258.Solomon BJ, Cappuzzo F, Felip E, et al. Intracranial efficacy of crizotinib versus chemotherapy in patients with advanced ALK-positive non-small-cell lung cancer: results from PROFILE 1014. J Clin Oncol 2016;34(24):2858-2865.

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