XALKORI® (crizotinib): ROS1 updated overall survival (OS) data

XALKORI®  is an option for the 1st-line treatment of ALK-positive advanced NSCLC, and the 1st and only treatment specifically indicated for ROS1-positive advanced NSCLC1 

Updated PROFILE 1001 study1

In the ongoing phase I PROFILE 1001 study, Xalkori (crizotinib) showed antitumor activity in patients with ROS1-rearranged advanced non-small-cell lung cancer (NSCLC). Initial results from 50 patients after a median follow-up of 16.4 months showed an objective response rate (ORR) of 72% and a median progression-free survival (PFS) of 19.3 months2.

Updated results from an additional 46.2 months’ median follow-up were published in April 2019, evaluating the long term antitumour activity, overall survival (OS) and safety data for crizotinib in 53 ROS1-positive NSCLC patients*1.

Study design1,3

Ongoing phase 1, open-label study of crizotinib, including an initial dose-escalation phase followed by a recommended phase 2 dose-expansion phase in molecularly defined patients with:

  • Histologically confirmed, locally advanced or metastatic NSCLC positive for ROS1 rearrangement
  • Eastern Cooperative Oncology Group performance status of 0–2
  • Patients with treated brain metastases were allowed in the study if stable for ≥2 weeks.

Patients were followed for a median of 62.6 months in total.


  • ORR was 72% (95% CI, 58–83) with a median duration of response of 24.7 months (95% CI, 15.2–45.3)
  • Median PFS was 19.3 months (95% CI, 15.2–39.1)*
  • Median OS was 51.4 months (95% CI, 29.3–not reached) and 4-year OS rate was 51%


In this updated analysis of PROFILE 1001, the efficacy of crizotinib in patients with ROS1-rearranged advanced NSCLC was highly consistent with the initial results previously published.

This update to PROFILE 1001 reports for the first time mature survival data. In this mostly pre-treated population of ROS1-positive patients, OS from the time of crizotinib initiation was remarkably prolonged with a median OS of 51.4 months and an OS rate of 51% at 48 months.

No new safety signals were observed and the safety profile was similar to previous reports in patients with ALK- or ROS1-rearranged NSCLC.

*Additional 3 patients from a separate cohort were retrospectively determined to be ROS1-positive and included in the updated analyses.


  1. Shaw AT, Riely GJ, Bang YJ, et al. Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Ann Oncol. 2019;30(7):1121-1126.
  2. Shaw AT, Ou SH, Bang YJ, et al. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014;371:1963-71.
  3. Shaw AT, Riely GJ, Bang YJ, et al. 107O - Crizotinib in advanced ROS1-rearranged non-small cell lung cancer (NSCLC): overall survival (OS) and updated safety from PROFILE 1001. Presented at the European Lung Cancer Congress, April 10–13, 2019; Geneva, Switzerland.

PP-XLK-GBR-1143. March 2020