This site is intended only for healthcare professionals resident in the United Kingdom

Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

See all Therapy areas

Click here for Xalkori® (crizotinib) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

PROFILE 1001 : ROS1+ NSCLC

XALKORI is an option for the first-line treatment of ALK-positive advanced NSCLC, and the treatment of ROS1-positive advanced NSCLC.1

PROFILE 1001: Multinational, single-arm study of XALKORI in ROS1+ advanced NSCLC2

In the ongoing phase I PROFILE 1001 study, Xalkori (crizotinib) showed antitumour 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 19.2 months.2 

Updated PROFILE 1001 study3

Updated results from an additional 46.2 months’ median follow-up were published in July 2019, evaluating the long-term antitumour activity, overall survival (OS) and safety data for crizotinib in 53 ROS1-positive NSCLC patients.*3

*Included three patients from an ALK-negative subgroup who were retrospectively identified as ROS1+3

Results3

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.
See Safety page

Study Design and Endpoints3,4

XALKORI is a targeted therapy with 5 years of clinical trial follow-up in ROS1+ advanced NSCLC.3,4

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

PROFILE 1001 was a multi-cohort study in patients with advanced cancer, including an expansion cohort with ROS1-positive NSCLC.2,3​​​​​​​
Three patients from a separate cohort were retrospectively determined to be ROS1-positive and included in the updated analyses using RECIST v1.1.3
​​​​​​​*ECOG PS 2 could enroll upon investigator and sponsor agreement.

BID, twice daily; CTCAE, Common Terminology Criteria for Adverse Events; ECOG, Eastern Cooperative Oncology Group; NSCLC, non-small cell lung cancer; PD, progressive disease; PO, orally; PS, performance status; RECIST, Response Evaluation Criteria in Solid Tumours.

ORR3

​​​​​​​(95% CI, 58–83)3

Median duration of response3

​​​​​​​(95% CI, 15.2–45.3)3

Median time to tumour response3

​​​​​​​(95% CI, 4.3–103.6)3

CI, confidence interval; NSCLC, non-small cell lung cancer; ORR, objective response rate.

Antitumour Activity3

Vertical lines on the curve indicate censoring of data. Adapted from Shaw AT, et al. Ann Oncol. 2019;30(7):1121-6. Median follow-up was 62.6 months.3
*Three patients from a separate cohort were retrospectively determined to be ROS1-positive and included in the updated analyses.3
CI, confidence interval; NSCLC, non-small cell lung cancer; PFS, progression-free survival.​​​​​​​

Progression Free Survival3,4

Kaplan-Meier curve estimating PFS4

Overall Survival3,4

Kaplan-Meier curve estimating OS3,4

Vertical lines on the curve indicate censoring of data.
Adapted from Shaw AT, et al. Ann Oncol. 2019;30(7):1121-6
Median follow-up was 62.6 months.3
* Three patients from a separate cohort were retrospectively determined to be ROS1-positive and included in the updated analyses.3
CI, confidence interval; NSCLC, non-small cell lung cancer; PFS, progression-free survival.

Safety

See all Xalkori Safety Information.

View

References
  1. XALKORI Summary of Product Characteristics
  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. Crizotinib in ROS1-rearranged advanced non-small cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Ann Oncol. 2019;30(7):1121-6.
  4. 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-1165. March 2021

Indication

XALKORI as a monotherapy is indicated for:1

  • The first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
  • The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)
  • The treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC)

Register to receive tailored information from Pfizer by email

Stay up to date with the latest relevant healthcare, medical and promotional information about medicines and vaccines promoted by Pfizer.

PP-PFE-GBR-2809. March 2021

Sign up now

For UK Healthcare Professionals*

These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.

I confirm that I am a healthcare professional* resident in the United Kingdom.

If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.

*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-PFE-GBR-2688. December 2020

Yes

No