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DosingSafetyClinical TrialsClinical TrialsXALKORI Clinical TrialsROS1+ NSCLC: PROFILE 1001ALK+ NSCLC: PROFILE 1014

Real World Evidence

Real World EvidenceReal World EvidenceSequential XALKORI® and Ceritinib in ALK+ NSCLCXALKORI® and Post-Progression Treatment in ALK+ NSCLC


The information on this website is based on data from adult patients with ALK (anaplastic lymphoma kinase)-positive / ROS 1-positive advanced NSCLC (non small cell lung cancer) treated with XALKORI®(crizotinib), produced in line with the XALKORI®(crizotinib) Summary of Product Characteristics. XALKORI® (crizotinib) Prescribing Information click here. Adverse event reporting information can be found at the bottom of the page.

OS from diagnosis according to systemic treatments initiated following progression on XALKORI® (n=263)*1

Progression-Free and Overall Survival in ALK+ NSCLC Patients Treated with Sequential XALKORI® and Ceritinib

Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational retrospective analyses are not intended for direct comparison with clinical trials.

Study Design

In this multicentre cohort, retrospective study, 73 patients with ALK+ advanced non-small cell lung cancer (NSCLC) were enrolled. Medical records were reviewed to determine progression-free survival (PFS) and overall survival (OS) following sequential treatment with XALKORI® and ceritinib.*1 

The majority of patients (n=56) received a starting dose of 750mg once-daily XALKORI®.1

*Median number of lines of therapy prior to XALKORI® was 1 (range: 0-8). 27.4% of patients were treated with other therapies between XALKORI® and ceritinib.1 

Patient Baseline Characteristics
                           Characteristic                                                       All Patients (N=73)                          
Age at diagnosis, years
Median 50
Range 22-72
Sex, n (%)
Male 38 (52%)
female 35 (48%)
Ethnicity, n (%)
Caucasian 54 (74%)
Asian 17 (23%)
Other 2 (3%)
Smoking history, n (%)
Never 57 (78%)
Light (≤10 pack years) 10 (14%)
Heavy (≥10 pack years) 6 (8%)
Histology, n (%)
Adenocarcinoma 69 (95%)
Squamous 3 (4%)
Adenosquamous 1 (1%)
Stage at disgnosis, n (%)
Stage I-II 2 (3%)
Stage III-IV 71 (97%)
Lines of therapy before crizotinib*, n (%)
0 10 (14%)
1 32 (44%)
2 16 (22%)
3 7 (10%)
4-8 8 (11%)
Brain metastases before crizotinib, n (%)
Present 25 (35%)
Absent 47 (65%)

*All patients received XALKORI® before eventual treatment with ceritinib.1
†Neuroimaging was not available in 1 patient.1
Adapted from Gainor JF, et al. Clin Cancer Res. 2015;21(12):2745-52.1
Data cutoff: June 2014

Study Results

Progression-Free Survival

For patients with ALK+ advanced NSCLC that have become resistant to XALKORI®, ceritinib has shown anti-tumour activity regardless of whether patients receive interim treatments after XALKORI®.1

With a median follow-up of 53.2 months (data cutoff: June 2014):1

Overall survival from the first XALKORI® dose1 

*2 patients permanently discontinued XALKORI® due to toxicity. The median duration of post-progression XALKORI® use was 25 days (range: 0–318). When patients transitioned to new systemic therapies, the majority (72.6%) received ceritinib as the next line of therapy.1

  • Within the overall study population (n=73), the combined PFS of XALKORI® and ceritinib was 17.4 months (95% CI: 15.5-19.4 months)1
  • For patients with no intervening therapies between XALKORI® and ceritinib (n=53), the combined mPFS was 17.0 months (95% CI: 15.6-19.8 months)1

Overall Survival

After a median follow-up of 53.2 months (data cutoff: June 2014), the median OS in the overall study population (n=73) was 49.4 months (95% CI: 35.5-63.1 months).1

OS from the time of metastatic NSCLC diagnosis for the overall study population*1 

Overall survival from the first XALKORI® dose1 


​​​​​​​*10 patients received XALKORI® in first line; the remainder in the second-line or later. The median number of lines of therapy prior to XALKORI® was 1 (range 0–8).1

Adapted from Gainor JF, et al. Clin Cancer Res. 2015;21(12):2745-52.1
Data cutoff: June 2014

ALK: anaplastic lymphoma kinase, CI: confidence interval, mPFS: median progression-free survival NSCLC: non-small cell lung cancer, OS: overall survival, PFS: progression-free survival

References

Gainor JF, et al. Clin Cancer Res. 2015;21(12):2745-52.
PP-XLK-IRL-0266 February 2024 Legal Category S1A Further information is available on request
Real World Evidence

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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