Click here for Xalkori® (crizotinib) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.
*ALK status determined using standard ALK break-apart FISH assay.
ALK, anaplastic lymphoma kinase; AUC, area under the curve; BID, twice a day; ECOG, Easter Cooperative Oncology Group; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; EQ-5D, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D); FISH, Fluorescence in situ hybridisation; IC TTP, intracranial time to progression; IRR, Independent Radiology Review; NSCLC, non-small-cell lung cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PO, by mouth; RECIST, Response Evaluation Criteria In Solid Tumours.
1st-line XALKORI offers your patients a RAPID and DURABLE response compared to chemotherapy.1,2
1st-line XALKORI significantly improved ALK+ advanced NSCLC patients global quality of life and 4 out of the 5 functioning domains from baseline vs. chemotherapy (P<0.001).2
The first PROFILE 1014 results were published in 2014 after a median follow-up of 17 months. The study met its primary endpoint showing the superiority of XALKORI to pemetrexed-plus-platinum chemotherapy for progression-free survival, as assessed by independent radiologic review. Median overall survival (OS) was not reached in either group at the time of the first report.2
To investigate the secondary endpoints of OS and safety in XALKORI versus pemetrexed-plus-platinum chemotherapy over an additional 3 years of follow-up to the initial PROFILE 1014 results.5
Kaplan-Meier curve estimating OS5
Adapted from Soloman et al 2018.5 aEstimated by Cox proportional hazards regression analysis with adjustment for ECOG PS, race, brain metastases; b2-sided p-value from the log-rank test stratified by ECOG PS, race, brain metastases.
Although statistical significance was not reached, 84.2% of patients in the chemotherapy arm crossed over to XALKORI as their first subsequent follow-up treatment and 19.2% of patients in the XALKORI arm crossed over to platinum-based chemotherapy.5 The rank-preserving structural failure time model (RPSFTM) was used to adjust for the effect of crossover on OS.
RPSFTM applies a parameter to relate the observed OS to its hypothetical OS, i.e. what would have been observed without crossover to other treatments.
Hence, the observed survival times for patients who crossed over were corrected to the survival time that would have been observed if there was no crossover.
Adapted from Soloman et al 2018.5 aCalculated using the stratified Cox proportional hazards regression approach applied to crossover adjusted data by a parameter derived using the stratification log-rank test and its bootstrap CI.
Adapted from Soloman et al 2018.2 Patients who did not receive subsequent therapy after XALKORI or chemotherapy, and patients still on XALKORI treatment at the end of the study are not shown.
Patients who received XALKORI followed by another ALK TKI were found to have a longer OS than those receiving XALKORI followed by any follow-up therapy other than an ALK TKI, as well as those patients who received chemotherapy first-line.5
CI, confidence interval; HR, hazard ratio; ITT, intention to treat; NSCLC, non-small cell lung cancer; TKI, tyrosine kinase inhibitor.
See all Xalkori Safety Information.
XALKORI as a monotherapy is indicated for:1
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