XALKORI® (crizotinib): Clinical efficacy data in ALK+ NSCLC

XALKORI® is an option for the 1st-line treatment of ALK-positive advanced NSCLC and the 1st and only treatment specifically indicated for ROS1-positive advanced NSCLC1

PROFILE 1014:

Study Design and Endpoints2

PROFILE 1014 is the 1st prospective, randomised Phase III trial to demonstrate superiority of 1st-line XALKORI over chemotherapy for ALK+ advanced NSCLC2

*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; 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.

For safety, see safety page or the XALKORI SmPC

References:
1.XALKORI® Summary of product characteristics
2.Solomon BJ, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014:371(23):2167-2177

PP-XLK-GBR-1129. March 2020

Progression-free survival1,2

XALKORI significantly prolonged median PFS to 10.9 months vs. 7.0 months with chemotherapy.1,2

Progression-free survival.1,2

A median OS of 4 years from metastatic diagnosis can be achieved when treatment includes Xalkori® followed by next generation ALK inhibitors at progression3

For safety, see the safety page or the XALKORISmPC.

References:
1. XALKORI® Summary of Product Characteristics
2. Solomon BJ, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014;371(23):2167–2177.
3. Gainor JF, et al. Progression-free and overall survival in ALK-positive NSCLC patients treated with sequential crizotinib and ceritinib. Clin Cancer Res. 2015;21(12):2745–2752.

PP-XLK-GBR-1130. March 2020

Objective response rate1,2

XALKORI® significantly improved objective response rate vs chemotherapy.1,2

1st-line XALKORI offers your patients a RAPID and DURABLE response compared to chemotherapy.1,2

  • 1.4 (0.6-9.5) months median time to response vs 2.8 (1.2-8.5) months with chemotherapy
  • 11.3 (8.1-13.3) months duration of response vs 5.3 (4.1-5.8) months with chemotherapy

For safety, see safety page or the XALKORI SmPC

References:
1. XALKORI® Summary of Product Characteristics
2. Solomon BJ, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014;371(23):2167–2177.

PP-XLK-GBR-1131. March 2020

1st-line XALKORI is an option for your patients with ALK-positive advanced NSCLC, including those with brain metastases.2,3

 

For safety, see safety page or the XALKORI SmPC.

References:
1. XALKORI® Summary of Product Characteristics
2. Solomon BJ 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 Aug 20;34(24):2858-65
3. Solomon BJ, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014;371(23):2167–2177.

PP-XLK-GBR-1132. March 2020

Quality of life

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

Quality-of-life improvements from baseline (QLQ-C30)2

For safety, see safety page or the XALKORI  SmPC.

References:
1. XALKORI® Summary of Product Characteristics
2. Solomon BJ, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014;371(23):2167–2177.

PP-XLK-GBR-1133. March 2020