104P - Efficacy of ceritinib in a "real-world" population of crizotinib-refractory ALK-positive NSCLCs: Results of the Italian compassionate use program

Date 07 May 2017
Event ELCC 2017
Session Poster Display Session
Topics Non-Small-Cell Lung Cancer, Locally Advanced
Cancer Immunology and Immunotherapy
Lung and other Thoracic Tumours
Presenter Giulio Metro
Citation Annals of Oncology (2017) 28 (suppl_2): ii28-ii51. 10.1093/annonc/mdx091
Authors G. Metro1, A. Passaro2, G. Lo Russo3, V. Gregorc4, R. Giusti5, E. Capelletto6, O. Martelli7, F.L. Cecere8, L. Bonanno9, R. Chiari10
  • 1Medical Oncology, Santa Maria della Misericordia Hospital, 06100 - Perugia/IT
  • 2Division Of Thoracic Oncology, Istituto Europeo di Oncologia, Milano/IT
  • 3Thoracic Oncology Unit, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano/IT
  • 4Medical Oncology, IRCCS San Raffaele, Milano/IT
  • 5Medical Oncology, Azienda Ospedaliera St. Andrea - Roma, Roma/IT
  • 6Medical Oncology, Università degli Studi di Torino, Torino/IT
  • 7Medical Oncology, S Giovanni Addolorata, Roma/IT
  • 8Medical Oncology, Istituto Regina Elena, Roma/IT
  • 9Medical Oncology 2, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 10Ospedale S. Maria della Misericordia, Perugia/IT

Abstract

Background

Ceritinib has been approved by EMA for the treatment of patients (pts) with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who progress on crizotinib. Nevertheless, this drug is not reimbursed in Italy by the National Health Care System as of January 2017. The aim of this study was to assess the efficacy of ceritinib administered within a compassionate use (CU) program made available to crizotinib-refractory patients.

Methods

This collaborative study involved multiple institutions in Italy. Clinical data from crizotinib-refractory pts with ALK-positive NSCLC who were requested ceritinib compassionate use (CU) were collected and analyzed.

Results

Twenty-four centres took part to the study, for a total of 70 pts who were requested ceritinib CU. Of these, 63 pts received at least one dose of ceritinib 750 mg/d from July 2014 to January 2017. Pts characteristics were as follows: median age 56 years (22-86), 34/63 (54%) female, 43/63 (68%) never smokers, 12/63 (19%) ECOG PS ≥ 2, 13/63 (21%) pretreated with ≥ 2 lines of chemotherapy, 49/63 (78%) metastatic to the brain. Median time on prior crizotinib was 370 days (51-1644). The most common any grade treatment-related adverse events (TRAEs) were nausea (60%, 6% grade 3 or 4), vomiting (49%, 5% grade 3 or 4), diarrhea (51% 2% grade 3 or 4), ALT elevation (48%, 17% grade 3 or 4), AST elevation (49%, 17% grade 3 or 4), and fatigue (59%, 8% grade 3 or 4). Dose reduction due to TRAEs occurred in 31/63 pts (49%). Out of 31 pts, 15 pts (49%) reduced the dose to 600 mg/d, 10 pts (32%) to 450 mg/d, and 6 pts (19%) to 300 mg/d. Unusual TRAEs consisted of an increase in serum creatinine in 3 pts. Of the 55 patients who were evaluable for response, 21 pts (38%) responded to treatment. Overall, at a median follow-up of 6.2 months (0.5-26), median progression-free survival (PFS) was 7.6 months and 6-month PFS was 59%.

Conclusions

The ceritinib CU program in Italy confirms the efficacy of the drug in a "real-world" setting, with a safety profile that is similar to that observed in clinical trials. A high rate of dose adjustments due to TRAEs was observed, which, however, did not appear to influence the activity of the drug.

Clinical trial identification

NA

Legal entity responsible for the study

N/A

Funding

Associazione Italiana per la Ricerca contro il Cancro

Disclosure

All authors have declared no conflicts of interest.