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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 1001 was a single-arm, open-label Phase 1 study evaluating the efficacy and safety of XALKORI® in patients with ROS1-positive (ROS1+) advanced non-small cell lung cancer (NSCLC).1,2
At time of data cutoff for the updated study results (30 June 2018), a total of 53 ROS1+ advanced NSCLC patients were enrolled in the study. This included 50 patients from the initial ROS1+ cohort (data cutoff: 16 May 2014), as well as 3 patients from a separate cohort that were retrospectively found to be ROS1+. All patients received 250mg XALKORI® orally twice daily.1,2
The primary endpoint was objective response rate (ORR) according to RECIST (v1.0 was used for the initial cohort of 50 ROS1+ patients, and v1.1 was used for the 3 patients retrospectively found to be ROS1+).†1,2
Adapted from Shaw AT, et al. N Engl J Med. 2014. and Shaw AT, et al. Ann Oncol. 2019.1,2
* Eastern Cooperative Oncology Group (ECOG) performance status ranges from 0 to 5, with higher numbers indicating increasing impairment in activities of daily living.1
† Best overall response was derived from investigator assessment using RECIST v1.0 (or RECIST v1.1 for the 3 patients in the ALK-negative NSCLC cohort).2
| Characteristics | ROS1+ patients (n=53) |
| Age (years) | |
| Median | 55 |
| Range | 25-81 |
| Sex (%)* | |
| Male | 43 |
| Female | 57 |
| Race (%)*† | |
| White | 57 |
| Asian | 40 |
| Black | 4 |
| Smoking status (%)* | |
| Never smoked | 75 |
| Former smoker | 25 |
| Histologic type (%)* | |
| Adenocarcinoma | 96 |
| Squamous cell carcinoma | 2 |
| Other | 2 |
| ECOG performance status (%)*‡ | |
| 0 | 43 |
| 1 | 55 |
| Previous regimens for advanced disease (%)*§ | |
| 0 | 13 |
| 1 | 42 |
| 2 | 23 |
| ≥3 | 23 |
| Median (range)‡ | 2 (1-6) |
Adapted from Shaw AT, et al. Ann Oncol. 2019.2
* Percentages may not total 100 due to rounding.
† Race was determined by the investigators.1
‡ ECOG performance status was assessed at the time of screening; the score was not reported for 1 patient in the XALKORI® group. Scores ranged from 0 to 5, with higher scores indicating increased disability. 1 patient (1.9%) had an ECOG performance score of 2 at baseline.1,2
§ Based on patients who received ≥1 prior advanced/metastatic regimen.2
The median duration of treatment was 64.5 weeks (95% CI: 2.3-182.0) and follow-up for OS was 16.4 months (95% CI: 13.8-19.8).1
| Endpoint | Median | 95% CI |
|---|---|---|
| ORR (primary endpoint) | 72% | 58-84% |
| Time to first response | 7.9 weeks | 4.3-32.0 weeks |
| Progression-free survival | 19.2 months | 14.4 months - not reached |
| Overall survival | Not reached | Not reached |
Adapted from Shaw AT, et al. N Eng J Med. 2014.1
Data cutoff: 16 May 2014.
With a median treatment duration of 22.4 months (95% CI: 15.0-35.9) and median follow-up of 62.6 months (95% CI: 58.2-66.6), the long-term anti-tumour activity of XALKORI® has been demonstrated in 53 patients with ROS1+ advanced NSCLC. Updated overall survival and safety data were also provided.2
Data from the updated analysis were consistent with the initial study results.2
At the time of follow-up (n=53):*2,3
• Primary endpoint: ORR was 72% (95% CI: 58-83%)
• Median time to first tumour response was 7.9 weeks (95% CI: 4.3-103.6 weeks)
• Median duration of tumour response was 24.7 months (95% CI: 15.2-45.3 months)
Adapted from Shaw AT, et al. Ann Oncol. 2019. Supplementary Figure S1 and Supplementary Material.3,4
Data cutoff: 30 June 2018.
* Median duration of XALKORI® treatment was 22.4 months (95% CI: 15.0-35.9 months). Median follow-up was 62.6 months (95% CI: 58.2-66.6 months).2
† Excludes 2 patients: one with early death and one with indeterminate response.4
‡ Patients with ALK+ NSCLC.4
At the time of follow-up, 68% of patients (n=53) experienced disease progression or death. The median PFS for patients treated with XALKORI® was 19.3 months (95% CI: 15.2-39.1).*2,4,5
Adapted from Shaw AT, et al. Ann Oncol. 2019. Supplementary Material S2.5
Data cutoff: 30 June 2018.
* Median duration of XALKORI® treatment was 22.4 months (95% CI: 15.0-35.9 months). Median follow-up was 62.6 months (95% CI: 58.2-66.6 months).2
Update first paragraph to: At time of follow-up, 49% of patients (n=53) had died. Median OS with XALKORI® was 51.4 months (95% CI: 29.3-not reached).*2
Adapted from Shaw AT, et al. Ann Oncol. 2019.2
Data cutoff: 30 June 2018.
* Median duration of XALKORI® treatment was 22.4 months (95% CI: 15.0-35.9 months). Median follow-up was 62.6 months (95% CI: 58.2-66.6 months).2
ALK: anaplastic lymphoma kinase, BID: twice daily, CI: confidence interval, CTCAE: common terminology criteria for adverse events, DOR: duration of response, ECOG: Eastern Cooperative Oncology Group, NSCLC: non-small cell lung cancer, ORR: objective response rate, OS: overall survival, PD: progressive disease, PO: orally, PFS: progression-free survial, PS: performance status, RECIST: response evaluation criteria in solid tumours, ROS: reactive oxygen species, TTR: time to response
References
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