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Background <p><i>ROS1</i> chromosomic rearrangement is a rare oncogenic driver, and patients with this rearrangement benefit from specific targeted treatments in the first-line setting. However, therapeutic options are limited in pretreated patients. Brigatinib is a validated drug for <i>ALK</i> rearrangements, and also has an in vitro activity against ROS1. In vivo efficacy is also suggested in some clinical series.</p> Objective <p>We aimed to specifically study brigatinib in patients with pretreated advanced non-small-cell lung cancer (NSCLC).</p> Methods <p>We retrospectively collected data from 20 centers in France. Brigatinib was delivered through a compassionate use program in France between 2018 and 2020. The primary endpoint was progression-free survival. Secondary endpoints were the objective response rate, overall survival, and tolerance.</p> Results <p>Twenty-five patients treated with brigatinib were included in our study. All patients were pretreated, and all of them previously received crizotinib. Median progression-free survival was 3.8 months (95% confidence interval 2.8–7.1). The objective response rate was 32%, with a disease control rate of 48%. Three patients had a prolonged response of more than 18 months at the end of data collection. We did not identify factors predictive of prolonged response. There were no grade 4 or 5 toxicities.</p> Conclusion <p>Brigatinib may represent an interesting therapeutic option for patients who have progressed after standard treatments.</p>

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Compassionate Access to Brigatinib for Patients with Non-small-cell Lung Cancer Harboring a ROS1 Rearrangement: Results from the BRIGAROS Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月13日

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  • Jean Mourlanette,
  • Gaelle Rousseau-Bussac,
  • Siham Mallah,
  • Florian Guisier,
  • Gerard Zalcman,
  • Rémi Veillon,
  • Clarisse Audigier-Valette,
  • Magali Roa,
  • Isabelle Nicolle,
  • Helene Doubre,
  • Nicolas Cloarec,
  • Régine Lamy,
  • Hugues Morel,
  • Hubert Curcio,
  • Aurélie Lagrange,
  • Roland Schott,
  • Marielle Sabatini,
  • Anne Claire Toffart,
  • Julian Pinsolle,
  • Jaafar Bennouna,
  • Christos Chouaid,
  • Julien Mazieres

摘要

Background

ROS1 chromosomic rearrangement is a rare oncogenic driver, and patients with this rearrangement benefit from specific targeted treatments in the first-line setting. However, therapeutic options are limited in pretreated patients. Brigatinib is a validated drug for ALK rearrangements, and also has an in vitro activity against ROS1. In vivo efficacy is also suggested in some clinical series.

Objective

We aimed to specifically study brigatinib in patients with pretreated advanced non-small-cell lung cancer (NSCLC).

Methods

We retrospectively collected data from 20 centers in France. Brigatinib was delivered through a compassionate use program in France between 2018 and 2020. The primary endpoint was progression-free survival. Secondary endpoints were the objective response rate, overall survival, and tolerance.

Results

Twenty-five patients treated with brigatinib were included in our study. All patients were pretreated, and all of them previously received crizotinib. Median progression-free survival was 3.8 months (95% confidence interval 2.8–7.1). The objective response rate was 32%, with a disease control rate of 48%. Three patients had a prolonged response of more than 18 months at the end of data collection. We did not identify factors predictive of prolonged response. There were no grade 4 or 5 toxicities.

Conclusion

Brigatinib may represent an interesting therapeutic option for patients who have progressed after standard treatments.