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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.

PROFILE 1001: XALKORI® for ROS1+ Advanced NSCLCStudy Design

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.* 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

Baseline Patient Characteristics
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.

Initial Study Results (data cutoff: May 16, 2014)

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 Study Results (data cutoff: June 30, 2018)

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)

Anti-Tumour ActivityORR by best change from baseline (n=51)*†2

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

Progression-Free Survival

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

Overall Survival

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

Scroll left to view table

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

XALKORI® Summary of Product Characteristics.Shaw AT, Ou SH, Bang YJ, et al. N Engl J Med. 2014;371:1963-71.Shaw AT, Riely GJ, Bang YJ, et al. Ann Oncol. 2019;30(7):1121-6.
PP-XLK-IRL-0260 February 2024 Legal Category S1A Further information is available on request
XALKORI® Clinical Trials

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