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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

Overall Survival with XALKORI® and Post-Progression* Treatments in Patients with ALK+ NSCLC

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

This French cohort retrospective study (ICFT-1302-CLINALK) sought to assess overall survival in ALK+ non-small cell lung cancer (NSCLC) patients given XALKORI® and understand whether survival outcomes were affected by post-progression* systemic treatments. All patients received 250mg oral XALKORI® twice daily. Progression was defined according to RECIST v1.1.1

Post-progression treatment options included:1

  • Next-generation ALK inhibitors (n=84)
  • Systemic treatments that were not ALK inhibitors (n=74)
  • Best supportive care (BSC; n=105)

At the time of analysis (data cutoff: July 31, 2015), 209 (65.7%) of the 318 patients enrolled on the study had died. The median duration of follow up was 44.4 months (95% confidence interval [CI]: 40.6-47.5 months).1

*The mean time from diagnosis of advanced disease to initiation of XALKORI® was 13.9 months (95% CI: 12.4-15.5 months). 14 patients were lost to follow-up.1
†Lorlatinib was an investigational compound at the time of the study.1

The primary endpoint of the study was overall survival (OS) measured from the date of the first dose of XALKORI®. Secondary endpoints included:1 

  • OS post-progression on XALKORI®
  • OS from diagnosis of metastatic disease
  • Objective response rate (according to RECIST v1.1; investigator-assessed)
  • Disease control rate
  • Progression-free survival (PFS; according to RECIST v1.1)
Patient Baseline Characteristics
                                   Characteristic                                                        All patients (N=318)               
N
318
Age, years
Median (range) 58.3 (19.2-88.4)
<65 221 (69.5%)
≥65 97 (30.5%)
Gender, n (%)
Male 161 (50.6%)
Female 157 (49.4%)
Ethnicity, n (%)
Non-Asian 294 (98.3%)
Asian 5 (1.7%)
Missing data  19
Smoking status, n (%)
Current-smoker 29 (9.4%)
Former-smoker 108 (34.8%)
Never-smoker 173 (55.8%)
Missing data  8
Histology, n (%)
Adenocarcinoma 292 (91.8%)
Large cell 19 (6.0%)
Other 7 (2.2%)
ECOG PS, n (%)
0 92 (31.6%)
1 133 (45.7%)
2 43 (14.8%)
3 21 (7.2%)
4 2 (0.7%)
Missing data  27
Stage at diagnosis, n (%)
Localised 5 (1.6%)
Locally advanced 45 (14.1%)
Metastatic 268 (84.3%)
Brain metastasis, n (%)
Yes 111 (34.9%)
No 207 (65.1%)
Line of therapy before crizotinib, n (%)
0 16 (5.0%)
1 172 (54.1%)
≥2 130 (40.9%)

Adapted from: Duruisseaux M, et al. Oncotarget. 2017;8(13):21903-17.1

Study Results

Overall Survival (OS)

The primary endpoint of the study was OS from the first crizotinib dose. Median OS from the first dose of XALKORI® was 16.6 months (95% CI: 12.2-19.6 months).1

Overall survival from the first XALKORI® dose1 

Overall survival from the first XALKORI® dose1 

Adapted from Duruisseaux M, et al. Oncotarget. 2017.1

Hazard ratio analysis of overall survival from the first dose of XALKORI®1


Tested Reference Univariable analysis Multivariable analysis
HR (95% CI) p value HR
(95% CI)
p value
Age <Median ≥Median 0.97 (0.74-1.27) 0.81

Gender Female Male 0.99
(0.75-1.29)
0.93

Smoking status Never Former/current 0.79
(0.60-1.03)
0.09 (-) NS
Current smoker No Yes 0.45
(0.30-0.69)
<0.001 0.44
(0.29-0.67)
<0.001
Histology Adenocarcinoma Non-Adenocarcinoma 0.64
(0.40-1.02)
0.06 0.59
(0.36-0.97)
0.04
PS 0-1 2-4 0.36
(0.27-0.50)
<0.001 0.35
(0.26-0.48)
<0.001
Stage III IV 0.84
(0.56-1.26)
0.40

Brain metastasis No Yes 0.95
(0.71-1.25)
0.70

Number of treatment lines before crizotinib 0-1 ≥2 0.79
(0.60-1.04)
0.09 (-) NS
Setting of administration EMA approval EAP 0.86
(0.63-1.17)
0.33

Overall survival from the first XALKORI® dose1 

Adapted from: Duruisseaux M, et al. Oncotarget. 2017;8(13):21903-17.1

Effect of Post-Progression Treatment on OS

263 patients were included in the analysis of the effect of systemic treatments following progression on XALKORI®. For patients who progressed on XALKORI® and were given an ALK inhibitor as post-progression therapy, the median OS from diagnosis of metastatic disease was 89.6 months (95% CI: 53.5-not reached).

This was in comparison to a median OS of:1

  • 28.2 months (95% CI: 22.1-33.0) for patients receiving systemic treatment other than next-generation ALK inhibitors (n=74; p<0.001)
  • 19.6 months (95% CI: 15.1-24.5) for patients receiving BSC (n=105; p<0.001) 

OS from diagnosis according to treatment initiated following progression on XALKORI®*1

Overall survival from the first XALKORI® dose1 

Adapted from Duruisseuax M, et al. Oncotarget. 2017.1
*Median duration of follow-up was 44.4 months.1

ALK: anaplastic lymphoma kinase, ALKi: anaplastic lymphoma kinase inhibitor, BSC: best supportive care, CI: confidence interval, EAP: Early Access Program, EMA: European Medicines Agency, HR: hazard ratio, NS: not significant, NSCLC: non-small cell lung cancer, OS: overall survival, PFS: progression-free survival, PS: performance score, RECIST: response evaluation criteria in solid tumours

References

Duruisseaux M, et al. Oncotarget. 2017;8(13):21903-17
PP-XLK-IRL-0265 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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