GLASS: Global Lorlatinib for ALK(+) and ROS1(+) retrospective Study: real world data of 123 NSCLC patients

Nir Peled, Roni Gillis, Saadettin Kilickap, Patrizia Froesch, Sergei Orlov, Elena Filippova, Umut Demirci, Petros Christopoulos, Irfan Cicin, Fatma Bugdayci Basal, Cengiz Yilmaz, Moiseenko Fedor, Taner Korkmaz, Semra Paydas, Oliver Gautschi, Alisan Zirtiloglu, Yesim Eralp, Havva Yesil Cinkir, Ahmet Sezer, Mustafa ErmanDeniz Tural, Hande Turna, Julien Mazieres, Elizabeth Dudnik, Noemi Reguart, David Ross Camidge, Terry L. Ng, Filiz Çay Şenler, İsmail Beypınar, Doğan Yazılıtaş, Ahmet Demirkazık, Aziz Karaoğlu, Kerem Okutur, Hasan Şenol Coşkun, Mehmet Ali Nahit Şendur, Abdurrahman Isikdogan, Devrim Cabuk, Perran Fulden Yumuk, Ibrahim Yıldız, M. Ali Kaplan, Özgür Özyılkan, İlhan Öztop, Omer Fatih Olmez, Kübra Aydin, Adnan Aydıner, Nezih Meydan, Roxana Denisa Grinberg, Laila C. Roisman

Research output: Contribution to journalArticlepeer-review

23 Scopus citations

Abstract

Lorlatinib is a third-generation tyrosine-kinases inhibitor (TKI) targeting ALK/ROS1 fusions. The FDA has approved lorlatinib for TKI-pretreated ALK(+) NSCLC, while its approval for ROS1(+) is still pending. Here we present the largest real-world data of NSCLC patients harboring ALK/ROS1 rearrangements treated with lorlatinib. Methods: 123 patients were enrolled retrospectively (data cut-off 1/1/2019). Lorlatinib was administered through an early access program for patients with no other available therapy. Outcome and response were defined by each investigator upon RECIST 1.1 criteria. Results: 106 ALK(+) and 17 ROS1(+) patients recruited from 8 different countries. The ALK(+) cohort included 50 % males, 73 % never-smokers and 68 % with brain metastases. Extracranial (EC) and intracranial (IC) response rates (RR) were 60 % and 62 %, with disease control rates (DCR) of 91 % and 88 % respectively. Mean duration of therapy (DoT) was 23.9 ± 1.6 months and median overall survival (mOS) was 89.1 ± 19.6 months. ROS1 cohort enrolled 53 % males, 65 % never-smokers and 65 % had brain metastases. EC and IC RR were 62 % and 67 % with DCR of 92 % and 78 % respectively. Median DoT was 18.1 ± 2.5 months and mOS of 90.3 ± 24.4 months. OS and DoT in both cohorts were not significantly correlated with line of therapy nor other parameters. The most common adverse events of any grade were peripheral edema (48 %), hyperlipidemia (47 %), weight gain (25 %) and fatigue (30 %). CNS adverse events such as cognitive effect of grade 1–2 were reported in 18 % of patients. Conclusion: Lorlatinib shows outstanding EC/IC efficacy in ALK/ROS1(+) NSCLC. The observed mOS of 89 ± 19 months in ALK(+) NSCLC supports previous reports, while mOS from of 90 ± 24 months is unprecedented for ROS1(+) NSCLC.

Original languageEnglish
Pages (from-to)48-54
Number of pages7
JournalLung Cancer
Volume148
DOIs
StatePublished - Oct 2020

Keywords

  • ALK
  • Lorlatinib
  • Real-world data
  • ROS1

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Fingerprint

Dive into the research topics of 'GLASS: Global Lorlatinib for ALK(+) and ROS1(+) retrospective Study: real world data of 123 NSCLC patients'. Together they form a unique fingerprint.

Cite this