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Crizotinib outcomes in ALK- positive advanced NSCLC patients with brain metastases 1 RTI Health Solutions, Research Triangle Park, NC/United States of.

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Presentation on theme: "Crizotinib outcomes in ALK- positive advanced NSCLC patients with brain metastases 1 RTI Health Solutions, Research Triangle Park, NC/United States of."— Presentation transcript:

1 Crizotinib outcomes in ALK- positive advanced NSCLC patients with brain metastases 1 RTI Health Solutions, Research Triangle Park, NC/United States of America, 2 RTI Health Solutions, Waltham, MA/United States of America, 3 Pfizer, Inc. New York, NY/United States of America Keith L. Davis, MA, 1 James A. Kaye, MD, DrPH, 2 Shrividya Iyer, PhD 2 Mini Oral Presentation at the 16 th World Conference on Lung Cancer, Sep 6-9, 2015, Denver, CO, USA Financial Disclosure: This study was sponsored by Pfizer, Inc.

2 2 Brain metastases are reported at initial diagnosis in 15-35% of patients with ALK+ metastatic non-small cell lung cancer (NSCLC) 1-3 Frequency of brain lesions can increase (up to 46% of ALK+ patients by one estimate 4 ) over the course of first-line therapy Crizotinib is an oral tyrosine kinase inhibitor (TKI) with proven efficacy against ALK+ tumors 3,5 Clinical benefits of crizotinib in ALK+ metastatic NSCLC patients with brain metastases have been documented in trial data 6 and in single-case reports 7 1. Doebele et al. Cancer 2012;118:4502-11. 2. Kang et al. Respir Med 2014;108:388-94. 3. Shaw et al. N Engl J Med 2013;368:2385-94. 4. Weickhardt et al. J Thorac Oncol 2012;7:1807-1814. 5. Ou et al. Ann Oncol 2014;25:415-22. 6. Costa DB et al. J Clin Oncol 2015. [Epub ahead of print]. 7. Kinoshita Y et a.. BMJ Case Rep 2013. doi:10.1136/bcr-2013-200867. Background

3 3 The clinical experience of crizotinib-treated patients with ALK+ metastatic NSCLC and brain metastases has not been widely assessed in real-world settings To help fill this research gap, we assessed the following in a small cohort of ALK+ metastatic NSCLC patients with brain metastases: –Demographic and clinical characteristics –Objective response rate (ORR) of primary tumor during crizotinib treatment and 1-year survival rates from crizotinib initiation –Status of brain lesions (intracranial response [ICR]) during crizotinib treatment Rationale and Objectives

4 4 Retrospective chart review (anonymized data, IRB approved) Data abstraction performed in 2014 by pooled sample of 147 oncologists in the US (n = 107) and Canada (n = 40) Patient inclusion criteria: –Adults (age ≥18) diagnosed with ALK+ metastatic NSCLC –Received crizotinib as first- or later-line treatment –First crizotinib treatment received between 8/1/2011 and 3/31/2013 (for US patients), or 4/12/2012 and 3/31/2013 (for Canadian patients) –Complete medical record through last crizotinib dose –Brain metastases present prior to or upon crizotinib initiation Analyses were descriptive and exploratory –Kaplan-Meier (K-M) methods used for 1-year survival rate estimates Methods Cohort for main study (n = 212) See 2016 WCLC Abstract No. 929 Cohort for present analyses (n = 33)

5 5 Results – Patient Demographics & Clinical Characteristics Demographics Age at crizotinib initiation, mean (SD) 57.6 (11.9) Sex, n (%) Male19 (57.6) Female14 (42.4) Ethnicity, n (%) White25 (75.8) Black5 (15.2) Asian/Pacific islander 3 (9.0) Clinical Characteristics Deceased at date of chart review, n (%) 10 (30.2) Current/former smoker, n (%)22 (66.7) ECOG at diagnosis, n (%) 0 or 118 (54.5) 2 or 315 (45.5) Adenocarcinoma histology, n (%) 28 (84.8) Crizotinib treatment duration (days), median 230

6 6 Results – Best Response (Primary Tumor) and Survival

7 7 Results – Status of Brain Lesions During Crizotinib Treatment Note: 71% of patients received either whole brain radiotherapy or stereotactic radiosurgery prior to crizotinib initiation.

8 8 Estimates based on small subsample (n = 33) of a larger multinational study –Small sample size limited study to descriptive, exploratory analyses (no multivariable adjustments for covariates) –Results may not be generalizable to entire ALK+ metastatic NSCLC population in the US or Canada No covariate adjustments –ICR, for example, may be confounded by prior treatments (71% rec’d either whole brain radiotherapy or stereotactic radiosurgery) Convenience sample –Non-randomized population –Timing and manner of assessments of ORR and ICR not protocol-driven (i.e., not assessed at pre-defined intervals, but rather at time points determined by the physicians in regular practice) Chart reviews subject to data entry/coding errors Study Limitations

9 9 Complete or partial response of the primary tumor during crizotinib treatment was seen in a majority of patients (ORR ~60%) 1-year survival (~80%) was higher than a recent trial-based report of ALK+ metastatic NSCLC patients with brain metastases (~65%) 6 Results support emerging literature on the possible clinical benefits of crizotinib in ALK+ metastatic NSCLC patients with brain metastases Findings provide signal that outcomes may be further optimized with earlier (first-line) initiation of crizotinib Conclusions 6. Costa DB et al. J Clin Oncol 2015. [Epub ahead of print].


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