Updated Overall Survival and Long-Term Safety With Ripretinib Versus Sunitinib in Patients With GI Stromal Tumor: Final Overall Survival Analysis From INTRIGUE

In the INTRIGUE phase III trial (ClinicalTrials.gov identifier: NCT03673501), adult patients with advanced gastrointestinal stromal tumor previously treated with imatinib were randomly assigned 1:1 to ripretinib 150 mg once daily or sunitinib 50 mg once daily (4 weeks on/2 weeks off). In the primary analysis, overall survival (OS) was immature. In this study, we report the final planned analysis of OS (key secondary end point), progression-free survival (PFS) on third-line therapy (second PFS; prespecified exploratory end point), and long-term safety. Final OS analysis was prespecified to occur with approximately 200 and ≥145 events in the overall and <i>KIT</i> exon 11 intention-to-treat (ITT) populations, respectively. As of March 15, 2023, there were 211 and 151 OS events in the overall ITT and <i>KIT</i> exon 11 ITT populations, respectively. Median OS was similar between second-line ripretinib and sunitinib in both populations (overall, 35.5 <i>v</i> 31.5 months; <i>KIT</i> exon 11, 35.5 <i>v</i> 32.8 months). Median second PFS (on third-line therapy) for the overall ITT population was similar between the ripretinib and sunitinib arms (7.7 <i>v</i> 7.4 months). Safety was consistent with the primary analysis. OS from this analysis was similar between arms, and second PFS suggests that receiving ripretinib did not adversely affect the PFS of third-line therapy.

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Publication Details

Journal
Journal of Clinical Oncology
Published
2025-05-23
DOI
https://doi.org/10.1200/jco-24-02818
Primary Topic
Gastrointestinal Tumor Research and Treatment
Type
article
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article

Updated Overall Survival and Long-Term Safety With Ripretinib Versus Sunitinib in Patients With GI Stromal Tumor: Final Overall Survival Analysis From INTRIGUE

Jonathan C. Trent, Yoon‐Koo Kang, John Raymond Zalcberg, David Goldstein et al.
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Journal of Clinical Oncology
Gastrointestinal Tumor Research and Treatment
article

Updated Overall Survival and Long-Term Safety With Ripretinib Versus Sunitinib in Patients With GI Stromal Tumor: Final Overall Survival Analysis From INTRIGUE

Jonathan C. Trent, Yoon‐Koo Kang, John Raymond Zalcberg, David Goldstein, Patrick Schöffski, Brittany L. Siontis, Hans A. J. Gelderblom, Rodrigo Ruiz‐Soto, Sebastian Bauer, P. H. Cox, César Sánchez, Jean‐Yves Blay, Robin L. Jones, Kjetil Boye, Steven Attia, Albiruni R. Abdul Razak, Suzanne George, Erika Davis, Matthew L. Sherman, Margaret von Mehren, Axel Le Cesne, Michael C. Heinrich
article en

Abstract

In the INTRIGUE phase III trial (ClinicalTrials.gov identifier: NCT03673501), adult patients with advanced gastrointestinal stromal tumor previously treated with imatinib were randomly assigned 1:1 to ripretinib 150 mg once daily or sunitinib 50 mg once daily (4 weeks on/2 weeks off). In the primary analysis, overall survival (OS) was immature. In this study, we report the final planned analysis of OS (key secondary end point), progression-free survival (PFS) on third-line therapy (second PFS; prespecified exploratory end point), and long-term safety. Final OS analysis was prespecified to occur with approximately 200 and ≥145 events in the overall and <i>KIT</i> exon 11 intention-to-treat (ITT) populations, respectively. As of March 15, 2023, there were 211 and 151 OS events in the overall ITT and <i>KIT</i> exon 11 ITT populations, respectively. Median OS was similar between second-line ripretinib and sunitinib in both populations (overall, 35.5 <i>v</i> 31.5 months; <i>KIT</i> exon 11, 35.5 <i>v</i> 32.8 months). Median second PFS (on third-line therapy) for the overall ITT population was similar between the ripretinib and sunitinib arms (7.7 <i>v</i> 7.4 months). Safety was consistent with the primary analysis. OS from this analysis was similar between arms, and second PFS suggests that receiving ripretinib did not adversely affect the PFS of third-line therapy.

Journal of Clinical OncologyVol. 43(20)
Oslo University Hospital (NO), Fox Chase Cancer Center (US), Royal Marsden NHS Foundation Trust (GB), Institute of Cancer Research (GB), Pontificia Universidad Católica de Chile (CL), Leiden University Medical Center (NL), Jacksonville College (US), Asan Medical Center (KR), Institut Gustave Roussy (FR), WinnMed (US), Princess Margaret Cancer Centre (CA), Portland VA Medical Center (US), University of Ulsan (KR), University of Miami Health System (US), Centre Léon Bérard (FR), Prince of Wales Hospital (AU), Dana-Farber Cancer Institute (US), Essen University Hospital (DE), Mayo Clinic in Arizona (US), Deciphera Pharmaceuticals (United States) (US), VA Portland Health Care System (US), Mayo Clinic in Florida (US), Sylvester Comprehensive Cancer Center (US), Alfred Health (AU), OHSU Knight Cancer Institute, Deutsches Konsortium für Translationale Krebsforschung (DE), Monash University (AU), University of Duisburg-Essen (DE), KU Leuven (BE)
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Gastrointestinal Tumor Research and Treatment
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