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Real World Evidence
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.
PROFILE 1001 was a multi-national, single-arm Phase I study of XALKORI® in patients with ROS1-positive (ROS1+) advanced non-small cell lung cancer (NSCLC).1,2
At the time of data cutoff for the initial study results (May 16, 2014), 50 ROS1+ advanced NSCLC patients were enrolled onto the study.2 At time of data cutoff for the updated study results (June 30, 2018), a total of 53 ROS1+ advanced NSCLC patients were enrolled in the study. This included 50 patients from the initial ROS1+ cohort as well as 3 patients from a separate cohort that were retrospectively found to be ROS1+.3 All patients received 250mg XALKORI® orally twice daily.2,3
The primary endpoint was objective response rate (ORR) according to RECIST(v1.0 was used for those in the initial cohort of 50 ROS1+ patients, and v1.1 was used for 3 patients in another cohort retrospectively found to be ROS1+).†3
Primary Endpoint = ORR.
Adapted from Shaw AT, et al. N Engl J Med. 2014.2 * Eastern Cooperative Oncology Group (ECOG) performance status ranges from 0 to 5, with higher numbers indicating increasing impairment in activities of daily living.2
† 50 ROS1+ advanced NSCLC were enrolled onto the study at data cutoff for the initial results. 53 ROS1+ advanced NSCLC patients were enrolled onto the study at the time of the updated analysis.2,3
‡ 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).2,3
| The baseline patient characteristics for the 53 ROS1+ patients enrolled on the PROFILE 1001 study were as follows:1 | |
|---|---|
| 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. Annals of Oncol. 2019.2
* Percentages may not total 100 due to rounding.
† Race was determined by the investigators.1
‡ ECOG 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. One patient (1.9%) had an ECOG performance score of 2 at baseline.1,2
§ Based on patients who received ≥1 prior advanced/metastatic regimen.
With a median follow-up of 16.4 months (95% confidence interval [CI]: 13.8-19.8) and median treatment duration of 64.5 weeks (95% CI: 2.3-182.0 weeks):2
| Endpoint | ROS1-Rearranged NSCLC | 95% CI |
|---|---|---|
| Objective response rate (primary endpoint) | 72% of patients | 58-84% |
| Median time to first response | 7.9 weeks | 4.3-32.0 weeks |
| Median Progression-free survival | 19.2 months | 14.4 months - not reached |
| Median Overall survival | Not reached | Not reached |
Updated results from a median follow-up of 62.6 months demonstrate the long-term anti-tumour activity of XALKORI®, and provide overall survival and safety data, in 53 patients* with ROS1+ advanced NSCLC. Data from the updated analysis were consistent with the initial study results.3
With a median of 62.6 months of follow-up:2,3
• 72% (95% CI: 58-83%) of patients achieved an ORR (primary endpoint)
• 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. N Engl J Med. 2014;371:1963-71.2
* Median follow-up was 62.6 months (95% CI: 58.2-66.6 months). Median duration of XALKORI® treatment was 22.4 months (95% CI: 15.0-35.9 months).2
† Excludes 2 patients: one with early death and one with indeterminate response.2
‡ Patients with ALK+ NSCLC.2
With a median follow-up of 62.6 months, 36 out of 53 patients (68%) experienced disease progression or death. The median PFS with XALKORI® was 19.3 months (95% CI: 15.2–39.1 months).*2,3
Adapted from Shaw AT, et al. Ann Oncol. 2019. Supplementary Material S2.3
*Median follow-up was 62.6 months (95% CI: 58.2-66.6 months). Median duration of XALKORI® treatment was 22.4 months (95% CI: 15.0-35.9 months).3
With a median follow-up of 62.6 months, 26 (49%) deaths occurred. Median OS with XALKORI® was 51.4 months (95% CI: 29.3 months-not reached).*2
Adapted from Shaw AT, et al. Ann Oncol. 2019.2
*Median follow-up was 62.6 months (95% CI: 58.2-66.6 months). Median duration of XALKORI® treatment was 22.4 months (95% CI: 15.0-35.9 months).2
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, TTR: time to response
References
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