The aim of this project, which has been commissioned by NICE through the NIHR HTA Programme as part of the NICE’s Single Technology Appraisal process, is to review the submission of the pharmaceutical company Pfizer Ltd on the evidence for the clinical and cost-effectiveness of lorlatinib for previously treated ALK-positive advanced non-small-cell lung cancer.

The clinical effectiveness evidence submitted by the company consists of one single arm, phase two study, Study 1001. This study investigates the single arm of lorlatinib for adult patients with metastatic (stage IV) ALK-positive NSCLC. The evidence presented is for the combined cohort EXP-3B:5 and consists of 139 patients. Comparator evidence was limited to chemotherapy and was provided by three studies: ALUR2 and ASCEND (progression free survival) and PROFILE 1001/1005 (overall survival).

The Aberdeen HTA Group has acted as the Evidence Review Group (ERG) for the project and provided an independent critique of the clinical and cost-effectiveness evidence submitted by the company. Based on the findings of the company submission and of the ERG’s critique, NICE has now released appropriate clinical guidance. Lorlatinib is recommended, within its marketing authorisation, as an option for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults whose disease has progressed after:

  • alectinib or ceritinib as the first ALK tyrosine kinase inhibitor or
  • crizotinib and at least 1 other ALK tyrosine kinase inhibitor.

Loelatinib is recommended only if the company provides it according to the agreed commercial arrangement.

For more information see:


Miriam Brazzelli;