Advances and future directions in ROS1 fusion-positive lung cancer

Boulanger, Mary C; Schneider, Jaime L; Lin, Jessica J

doi:10.1093/oncolo/oyae205

Cited by 38Lung Cancer Treatments and MutationsLung Cancer Research StudiesLung Cancer Diagnosis and Treatment

Advances and future directions in ROS1 fusion-positive lung cancer

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Boulanger, Mary C, Schneider, Jaime L, Lin, Jessica J·2024·The Oncologist

DOI 10.1093/oncolo/oyae205PMC PMC11546726

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Abstract

ROS1 gene fusions are an established oncogenic driver comprising 1%-2% of non–small cell lung cancer (NSCLC). Successful targeting of ROS1 fusion oncoprotein with oral small-molecule tyrosine kinase inhibitors (TKIs) has revolutionized the treatment landscape of metastatic ROS1 fusion-positive (ROS1+) NSCLC and transformed outcomes for patients. The preferred Food and Drug Administration-approved first-line therapies include crizotinib, entrectinib, and repotrectinib, and currently, selection amongst these options requires consideration of the systemic and CNS efficacy, tolerability, and access to therapy. Of note, resistance to ROS1 TKIs invariably develops, limiting the clinical benefit of these agents and leading to disease relapse. Progress in understanding the molecular mechanisms of resistance has enabled the development of numerous next-generation ROS1 TKIs, which achieve broader coverage of ROS1 resistance mutations and superior CNS penetration than first-generation TKIs, as well as other therapeutic strategies to address TKI resistance. The approach to subsequent therapy depends on the pace and pattern of progressive disease on the initial ROS1 TKI and, if known, the mechanisms of TKI resistance. Herein, we describe a practical approach for the selection of initial and subsequent therapies for metastatic ROS1+ NSCLC based on these clinical considerations. Additionally, we explore the evolving evidence for the optimal treatment of earlier-stage, non–metastatic ROS1+ NSCLC, while, in parallel, highlighting future research directions with the goal of continuing to build on the tremendous progress in the management of ROS1+ NSCLC and ultimately improving the longevity and well-being of people living with this disease.

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Patients treated with first-generation ROS1 TKIs progress because of off-target bypass pathway activation, leading to refractory disease, development of on-target acquired resistance mutations such as G2032R, or brain metastases.
“ROS1 tyrosine kinase inhibitors (TKIs) transformed clinical outcomes for ROS1+ NSCLC; however, patients treated with first-generation TKIs progress because of off-target bypass pathway activation, leading to refractory disease, development of on-target acquired resistance mutations such as G2032R, or brain metastases.1,6”
From Taletrectinib in ROS1 + Non–Small Cell Lung Cancer: TRUST (2025) · cites this paper as [6]

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Authors: Boulanger, M. C., Schneider, J. L., & Lin, J. J.
Affiliations: Massachusetts General Hospital (US)
Corresponding author: Lin, Jessica J
ORCID: Boulanger, Mary C
Schneider, Jaime L
Lin, Jessica J
Venue: The Oncologist
Publisher: Oxford University Press (OUP)
Published: 2024-08-23
Volume: 29
Issue: 11
Pages: 943-956
ISSN: 1083-7159 (ISSN-L)
1549-490X
DOI: 10.1093/oncolo/oyae205
PMC: PMC11546726
OpenAlex: W4401835091
Cited by: 38
References: 116
Citations by year: 2026: 28 · 2025: 9 · 2024: 1
FWCI: 2.80
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (vor)
Locations: The Oncologist (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
Funders: National Cancer Institute (R01CA164273, T32CA071345)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: ROS1 rearrangement, non-small cell lung cancer, tyrosine kinase inhibitors, crizotinib, entrectinib, repotrectinib, tyrosine kinase inhibitor resistance, CNS penetration, first-line therapy selection, second-line therapy, targeted therapy
MeSH terms: Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Protein-Tyrosine Kinases, Proto-Oncogene Proteins, Oncogene Proteins, Fusion, Drug Resistance, Neoplasm, Protein Kinase Inhibitors

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