Updated Overall Survival and Long-Term Safety With Ripretinib Versus Sunitinib in Patients With GI Stromal Tumor: Final Overall Survival Analysis From INTRIGUE
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 KIT 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 KIT exon 11 ITT populations, respectively. Median OS was similar between second-line ripretinib and sunitinib in both populations (overall, 35.5 v 31.5 months; KIT exon 11, 35.5 v 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 v 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.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (22)
Michael C. Heinrich
Division of Hematologic Malignancies, Knight Cancer Institute, Oregon Health & Science University, Portland, OR
Jean-Yves Blay
Hans Gelderblom
Suzanne George
Dana-Farber Cancer Institute, Boston, MA
Patrick Schöffski
From the Sandra and Edward Meyer Cancer Center (J.D.W.) and the Department of Medicine (J.D.W., M.A.P.), Weill Cornell Medicine, and Memorial Sloan Kettering Cancer Center (M.A.P.) — both in New York; Istituto Oncologico Veneto, IRCCS, Padua (V.C.-S.), European Institute of Oncology, IRCCS, Milan (P.Q.), Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola (M.G.), University of Siena and the Center for Immuno-Oncology, University Hospital of Siena, Siena (M.M.), and Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.) — all in Italy; Maria Sklodowska-Curie National Institute of Oncology, Warsaw, Poland (P.R.); Texas Oncology–Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); University Hospital Essen, the German Cancer Consortium, the National Center for Tumor Diseases–West, the Research Alliance Ruhr, Research Center One Health, and University Duisburg-Essen — all in Essen, Germany (D.S.); the College of Medicine, Swansea University, Swansea (J.W.), Brist...
Margaret von Mehren
John R. Zalcberg
Monash University School of Public Health and Preventive Medicine and Department of Medical Oncology, Alfred Health, Melbourne, VIC, Australia
Robin L. Jones
Yoon-Koo Kang
Albiruni Abdul Razak
Jonathan Trent
Sylvester Comprehensive Cancer Center, University of Miami Health System, Miami, FL
Steven Attia
avin Ratan, MD, MEd, Division of Cancer Medicine, Department of Sarcoma Medical Oncology, University of Texas, MD Anderson Cancer Center, Houston, TX; Bernd Kasper, MD, PhD, Sarcoma Unit, Mannheim University Medical Center, Mannheim Cancer Center, University of Heidelberg, Mannheim, Germany; Thierry Alcindor, MD, MS, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA; Patrick Schöffski, MD, Department of General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, KU Leuven, Leuven, Belgium; Winette T. van der Graaf, MD, PhD, Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands; Noah Federman, MD, Departments of Pediatrics and Orthopedics, UCLA Jonsson Comprehensive Cancer Center, UCLA David Geffen School of Medicine, Los Angeles, CA; Nam Q. Bui, MD, Division of Oncology, Department of Medicine, Stanford University, Stanford, CA; Gina D'Amato, MD, Sylvester Comprehensive Cancer Center, University of Miami Health System, Miami, FL; Richard...
Axel Le Cesne
Kjetil Boye
Oslo University Hospital, Oslo, Norway
David Goldstein
Cesar Sanchez
26University of Arkansas for Medical Sciences, Little Rock, United States
Brittany L. Siontis
Mayo Clinic Rochester, Rochester, MN
Paulina Cox
AVEO Pharmaceuticals, Inc., Boston, MA
Erika Davis
Deciphera Pharmaceuticals, LLC, Waltham, MA
Matthew L. Sherman
Deciphera Pharmaceuticals, LLC, Waltham, MA
Rodrigo Ruiz-Soto
Deciphera Pharmaceuticals, LLC, Waltham, MA
Sebastian Bauer