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Background <p>Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor, has demonstrated efficacy in pivotal trials in both pretreated and treatment-naïve patients with ALK-positive non-small-cell lung cancer (NSCLC). However, real-world evidence from large multicenter cohorts remains limited.</p> Methods <p>We conducted a retrospective multicenter study including 114 patients with advanced ALK-positive NSCLC treated with brigatinib across 28 centers in Turkey between May 2020 and December 2024. Objective response rate (ORR) was assessed by RECIST v1.1. Median progression-free survival (mPFS) and overall survival (mOS) were estimated by the Kaplan–Meier method, and prognostic factors were analyzed using Cox regression.</p> Results <p>The median age was 55&#xa0;years. Brigatinib was administered as first-line therapy in 68.4% of cases. In the overall cohort, the mPFS and OS were 24.2 and 44.2&#xa0;months. The ORR was 70.2%. In the first-line setting, the ORR was 79.5%, with an mPFS of 28.6&#xa0;months and an mOS of 50.3&#xa0;months. In contrast, those treated in the second-line or later setting had less-favorable outcomes, which independently correlated with worse OS in multivariate analysis. Patients with baseline brain metastases achieved favorable outcomes, with an mPFS of 26.2&#xa0;months, an mOS of 46.3&#xa0;months, and an ORR of 76.5%. Adverse events were reported in 83.3% of patients, most commonly gastrointestinal toxicities, creatine phosphokinase elevation, and liver enzyme abnormalities.</p> Conclusion <p>This nationwide multicenter study offers comprehensive real-world evidence confirming the effectiveness and tolerability of brigatinib in ALK-positive NSCLC, with especially favorable outcomes in the first-line setting and in patients with brain metastases.</p>

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Real-world effectiveness and safety of brigatinib in advanced ALK-positive NSCLC: a nationwide multicenter study by the Turkish Oncology Group

  • 期刊论文

  • 发表日期：

    2026年2月11日

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  • Salih Tunbekici,
  • Hamit Bal,
  • Oguzcan Kınıkoglu,
  • Hayati Arvas,
  • Harun Muglu,
  • Ahmet Bilici,
  • Mustafa Seyyar,
  • Halil Goksel Guzel,
  • Banu Ozturk,
  • Ozge Yalıcı,
  • Duygu Ozaskın,
  • Ramazan Cosar,
  • Fatmagul Cıkladılmez,
  • Evrican Zin,
  • Aytac Terzi,
  • Tugce Ulaslı,
  • Taha Koray Sahın,
  • Denız Can Guven,
  • Gamze Serın,
  • Merve Bıyıklı Alemdar,
  • Bilgin Demir,
  • Ali Kalem,
  • Pervin Can,
  • Kazım Uygun,
  • Elif Sahin,
  • Teoman Sakalar,
  • Ali Kaan Guren,
  • Gokhan Ozturk,
  • Enes Yesılbas,
  • Tugce Kubra Gunes,
  • Burcu Belen,
  • Muzaffer Ugraklı,
  • Kursat Dıslı,
  • Ahmet Oruc,
  • Melek Karakurt Eryılmaz,
  • Ismet Culcuoglu,
  • Mustafa Ersoy,
  • Bahadır Koylu,
  • Fatih Selcukbiricik,
  • Oguzhan Yıldız,
  • Mehmet Emın Yılmaz,
  • Saadettin Kılıckap,
  • Ertugrul Bayram,
  • Caner Acar,
  • Gokhan Sahin,
  • Haydar Cagatay Yuksel,
  • Mustafa Murat Mıdık,
  • Pınar Gursoy,
  • Erdem Goker

摘要

Background

Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor, has demonstrated efficacy in pivotal trials in both pretreated and treatment-naïve patients with ALK-positive non-small-cell lung cancer (NSCLC). However, real-world evidence from large multicenter cohorts remains limited.

Methods

We conducted a retrospective multicenter study including 114 patients with advanced ALK-positive NSCLC treated with brigatinib across 28 centers in Turkey between May 2020 and December 2024. Objective response rate (ORR) was assessed by RECIST v1.1. Median progression-free survival (mPFS) and overall survival (mOS) were estimated by the Kaplan–Meier method, and prognostic factors were analyzed using Cox regression.

Results

The median age was 55 years. Brigatinib was administered as first-line therapy in 68.4% of cases. In the overall cohort, the mPFS and OS were 24.2 and 44.2 months. The ORR was 70.2%. In the first-line setting, the ORR was 79.5%, with an mPFS of 28.6 months and an mOS of 50.3 months. In contrast, those treated in the second-line or later setting had less-favorable outcomes, which independently correlated with worse OS in multivariate analysis. Patients with baseline brain metastases achieved favorable outcomes, with an mPFS of 26.2 months, an mOS of 46.3 months, and an ORR of 76.5%. Adverse events were reported in 83.3% of patients, most commonly gastrointestinal toxicities, creatine phosphokinase elevation, and liver enzyme abnormalities.

Conclusion

This nationwide multicenter study offers comprehensive real-world evidence confirming the effectiveness and tolerability of brigatinib in ALK-positive NSCLC, with especially favorable outcomes in the first-line setting and in patients with brain metastases.