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Real World Evidence
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.
PROFILE 1014 was a randomised, open-label Phase 3 trial comparing XALKORI® with chemotherapy in 343 patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC). It was the first trial demonstrate superiority of XALKORI® over chemotherapy in terms of progression-free survival (PFS) for previously-untreated ALK+ advanced NSCLC.1
Adapted from Solomon BJ, et al. N Eng J Med. 2014.1
* Eastern Cooperative Oncology Group (ECOG) performance status ranges from 0 to 5,with higher numbers indicating increasing disability.1
| The baseline patient characteristics for the intention-to-treat population of the PROFILE 1014 study (N=343) were as follows:1 | ||
|---|---|---|
| Characteristic | XALKORI® (n=172) | Chemotherapy (n=171) |
| Age (years) | ||
| Median | 52 | 54 |
| Range | 22-76 | 19-78 |
| Sex (%)* | ||
| Male | 40 | 37 |
| Female | 60 | 63 |
| Race (%)*† | ||
| White | 53 | 50 |
| Asian | 45 | 47 |
| Other | 2 | 4 |
| Smoking status (%)* | ||
| Never smoked | 62 | 65 |
| Former smoker | 33 | 32 |
| Current smoker | 6 | 3 |
| Histologic characteristics of tumour (%)* | ||
| Adenocarcinoma | 94 | 94 |
| Non-adenocarcinoma | 6 | 6 |
| ECOG performance status (%)*‡ | ||
| 0 or 1 | 94 | 95 |
| 2 | 6 | 5 |
| Extent of disease (%)* | ||
| Locally advanced | 2 | 2 |
| Metastatic | 98 | 98 |
| Time since first diagnosis (months) | ||
| Median | 1.2 | 1.2 |
| Range | 0-114.0 | 0-93.6 |
| Brain metastases present (%)* | ||
| Yes | 26 | 27 |
Adapted from Solomon BJ, et al. N Eng J Med. 2014.1
* Percentages may not total 100 due to rounding.
† Race was self-reported.1
‡ ECOG PS was assessed at the time of screening; the score was not reported for one patient in the XALKORI® group. Scores ranged from 0 to 5, with higher scores indicating increased disability.1
The pre-specified number of events of progression or death to detect a 50% improvement in the primary endpoint was estimated to be 229. These were reached and the data cutoff was determined to be 30 November 2013.1
At the time of data cutoff, the median overall survival (OS) had not been reached for either arm. Median duration of treatment was 10.9 months (95% CI: 0.4-34.3 months) for XALKORI® and 4.1 months (95% CI: 0.7-6.2 months) for chemotherapy. Median duration of follow-up for OS was 17.4 months for XALKORI® and 16.7 months for chemotherapy.1
At the time of follow-up*, XALKORI® significantly prolonged median PFS in patients with ALK+ advanced NSCLC compared to chemotherapy (10.9 months vs. 7.0 months, respectively). XALKORI® reduced the risk of progression or death by 55% compared to chemotherapy (hazard ratio [HR]: 0.45 [95% CI: 0.35-0.60]; p<0.001).1
Adapted from Solomon BJ, et al. N Eng J Med. 2014.1
Data cutoff: 30 November 2013.
* Median duration of treatment was 10.9 months (95% CI: 0.4-34.3 months) for XALKORI® and 4.1 months (95% CI: 0.7-6.2 months) for chemotherapy. Median duration of follow-up for OS was 17.4 months for XALKORI® and 16.7 months for chemotherapy.1
At the time of follow-up*, the HR favoured XALKORI® over chemotherapy for most pre-specified subgroups.1
Adapted from Solomon BJ, et al. N End J Med. 2014.1
Data cutoff: 30 November 2013.
*Median duration of follow-up for OS was 17.4 months for XALKORI(R) and 16.7 months for chemotherapy. Median duration of treatment was 10.9 months (95% CI: 0.4-34.3 months) for XALKORI® and 4.1 months (95% CI: 0.7-6.2 months) for chemotherapy.1
† Race was self-reported.1
‡ ECOG PS was assessed at the time of screening; the score was not reported for one patient in the XALKORI® group. Scores ranged from 0 to 5, with higher scores indicating increased disability.1
The intracranial efficacy of XALKORI® vs. chemotherapy was prospectively evaluated in the PROFILE 1014 study. Of the 343 patients in the ITT population, 23% had treated brain metastases identified by IRR and 77% did not.2
XALKORI® was shown to significantly improve median PFS over chemotherapy for patients without and with treated brain metastases at baseline:2
• Brain metastases present at baseline (HR: 0.40 [95% CI: 0.23-0.69]; p<0.001)
• Brain metastases absent at baseline (HR: 0.51 [95% CI: 0.38-0.69]; p<0.001)
| Treated metastases present at baseline | Treatment arm (n) | Median PFS* | Hazard ratio (95% CI) | P-value |
|---|---|---|---|---|
| Yes | XALKORI® (n=39) | 9.0 months | 0.40 (95% CI: 0.23-0.69) | 0.001 |
| Chemotherapy (n=40) | 4.0 months | |||
| No | XALKORI® (n=132) | 11.1 months | 0.51 (95% CI: 0.38-0.69) | 0.001 |
| Chemotherapy (n=131) | 7.2 months |
Adapted from Solomon BJ, et al. JCO. 2016.2
* Using a two-sided log-rank test (ITT population: stratified; patient subgroups with or without baseline brain metastases: unstratified).2
At time of follow-up*, XALKORI® demonstrated a significantly improved objective response rate (ORR) compared to chemotherapy. 74% of patients in the XALKORI® arm (n=172) achieved an ORR, compared to 45% in the chemotherapy arm (n=171; p<0.001).*1
Furthermore, XALKORI® offered rapid and durable responses compared to chemotherapy:1
Adapted from Solomon BJ, et al. NEJM. 2014.1
Data cutoff: 30 November 2013.
* Median duration of treatment was 10.9 months (95% CI: 0.4-34.3 months) for XALKORI® and 4.1 months (95% CI: 0.7-6.2 months) for chemotherapy. Median duration of follow-up for OS was 17.4 months for XALKORI® and 16.7 months for chemotherapy.1
† The time to tumour response was calculated from the date of randomisation to the date of the first documentation of a partial or complete response as determined by independent radiologic review.1
‡ The duration of response was calculated from the date of the first documentation of a partial or complete response to the date of RECIST-defined progression or death, with the use of the Kaplan-Meier method.1
XALKORI® significantly improved patients' global quality of life compared to chemotherapy (p<0.001), and was associated with a significantly greater improvement from baseline in physical, social, emotional and role functioning domains (p<0.001).* A change of 10 points or more was considered to be a clinically meaningful change.1
There was also a significantly greater overall reduction from baseline with XALKORI® compared to chemotherapy in symptoms of pain, dyspnoea and insomnia (p<0.001).*1
Adapted from Solomon BJ, et al. N Eng J Med. 2014.1
Data cutoff: 30 November 2013.
*As assessed using the QLQ-C30. Patient-reported outcomes were assessed at baseline, on days 7 and 15 of cycle 1, on day 1 of every subsequent cycle, and at the end of treatment. Scores on each scale ranged from 0 to 100. For global quality of life and functioning domains, higher scores indicate better global quality of life or functioning. For symptoms, lower scores indicate reduction in symptoms.1
Adapted from Solomon BJ, et al. J Clin Oncol. 2018.3
Data cutoff: 30 November 2016.
* Median treatment duration with XALKORI® was 14.7 months and with chemotherapy was 4.1 months. Median follow-up for final OS was approximately 46 months for both the XALKORI® and chemotherapy arms.3
Adapted from Solomon BJ, et al. J Clin Oncol. 2018.3
Data cutoff: 30 November 2016.
* Median treatment duration with XALKORI® was 14.7 months and with chemotherapy was 4.1 months. Median follow-up for final OS was approximately 46 months for both the XALKORI® and chemotherapy arms.3
ALK: anaplastic lymphoma kinase, AUC: area under the curve, BID: twice a day, CI: confidence interval, ECOG: Eastern Cooperative Oncology Group, EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer quality of life questionnaire-core 30, EQ-5D: EuroQol group 5-dimension self-report questionnaire (EQ-5D), FISH: fluorescence in situ hybridisation, HR: hazard ratio, IC TTP: intra cranial time to progression, IRR: independent radiology review, ITT: intention to treat, NSCLC: non small cell lung cancer, NR: not reached, ORR: objective response rate, OS: overall survival, PFS: progression-free survival, PO: by mouth, PS: performance score, QOL: quality of life, RECIST: response evaluation criteria in solid tumours, RPSFTM, rank preserving structural failure time model, TKI: tyrosine kinase inhibitor
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