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DosingDosingDosingSafetySafetySafetyClinical 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+ NSCLC treated with XALKORI®(crizotinib), produced in line with the XALKORI®(crizotinib) Summary of Product Characteristics for Great Britain. For XALKORI® (crizotinib) Prescribing Information for Great Britain and Northern Ireland 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 (Real World Evidence)

In this multicentre cohort, retrospective study, outcomes of 73 patients with ALK+ advanced non-small cell lung cancer (NSCLC) were analysed. Medical records were reviewed to determine progression-free survival (PFS) and overall survival (OS) following sequential treatment with XALKORI® and ceritinib. The median number of lines of treatment prior to XALKORI® was 1 (range: 0-8).

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%)

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

Study Results (Real World Evidence)

Progression-Free Survival

  • Among 73 ALK+ patients, the median PFS (mPFS) on XALKORI® was 8.2 months (95% CI: 7.4–10.6)1
  • The median interval from XALKORI® discontinuation to initiation of ceritinib was 25 days (range: 1–694)1
  • The median combined PFS for sequential treatment with XALKORI® and ceritinib was 17.4 months (95% CI: 15.5–19.4)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

Among 25 ALK+ patients with brain metastases identified prior to initiation of
crizotinib, the median OS was 42.2 months (95% CI: 26.4–51.2).1

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-GBR-1292 | March 2024
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