Michael C. Heinrich, MD, summarizes the results of an exploratory ctDNA biomarker analysis from the phase 3 INTRIGUE trial in advanced GIST. This analysis explored baseline ctDNA to assess whether imatinib-resistant KIT mutation patterns were associated with outcomes with ripretinib versus sunitinib as second-line therapy. Ripretinib has not been approved by the US FDA for second-line use in advanced GIST. This analysis was exploratory, and no statistical significance can be claimed or cited in clinical practice.

Watch Dr. Heinrich's expert review of this article here. 

Disclosures:

This information is being provided in the context of scientific exchange and is not intended for promotion. These scientific publications contain information about uses outside of the FDA-approved labeling for ripretinib. Ripretinib has not been approved by the FDA for use in second-line gastrointestinal stromal tumor (GIST) and the safety and effectiveness in this setting has not been established. Providing this information should not be construed as a recommendation for unapproved uses.

Ripretinib is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. There are no contraindications for ripretinib. Warnings and Precautions associated with ripretinib include: Palmar-Plantar Erythrodysesthesia Syndrome, New Primary Cutaneous Malignancies, Hypertension, Cardiac Dysfunction, Risk of Impaired Wound Healing, Photosensitivity, and Embryo-Fetal Toxicity. Please refer to the FDA-required labeling for ripretinib for complete details.

These clinical studies were supported by Deciphera and the following authors are or were employees of the company: Ying Su, Julie Meade, Tao Wang, William Reichmann, Kam Sprott, Haroun Achour, Matthew L. Sherman, and Rodrigo Ruiz-Soto.

Additional authors who have received compensation from Deciphera include Michael C. Heinrich (Consulting/Advisory Role), Robin L. Jones (Consulting/Advisory Role), Suzanne George (Consulting/Advisory Role, Institutional Research Funding), Hans Gelderblom (Institutional Research Funding), Patrick Schöffski (Consulting/Advisory Role), Margaret von Mehren (Consulting/Advisory Role, Institutional Research Funding), John R. Zalcberg (Honoraria, Consulting/Advisory Role, Travel/Accommodation Support), Albiruni Abdul Razak (Research Funding), Jonathan Trent (Consulting/Advisory Role), Steven Attia (Institutional Research Funding), Axel Le Cesne (Honoraria), Brittany L. Siontis (Consulting/Advisory Role, Institutional Research Funding), Neeltje Steeghs (Institutional Research Funding), Mihaela Druta (Consulting/Advisory Role, Speaker Bureau Participation), César Serrano (Consulting/Advisory Role, Honoraria), Neeta Somaiah (Consulting/Advisory Role, Research Funding), Ping Chi (Consulting/Advisory Role, Institutional Research Funding), Jean-Yves Blay (Honoraria, Consulting/Advisory Role, Institutional Research Funding), Sebastian Bauer (Honoraria, Consulting/Advisory Role).

See authors’ full disclosures of potential conflicts of interest contained within the publication.

If you have any questions, please contact the Medical Information Department at 1-888-724-3274 or medicalinformation@deciphera.com.