The phase 3 INTRIGUE trial demonstrated that ripretinib (Qinlock®), a switch-control tyrosine kinase inhibitor, has similar efficacy as sunitinib for gastrointestinal stromal tumors (GISTs) but with a more favorable safety profile and better tolerability.
The results, published in the Journal of Clinical Oncology, reported meaningful clinical activity of ripretinib with better tolerability and fewer serious adverse events.
“These full phase 3 INTRIGUE study results continue to deepen our understanding of Qinlock and its place in the GIST treatment landscape,” Matthew L. Sherman, MD, chief medical officer of Deciphera Pharmaceuticals, said in a press release.
“Although the INTRIGUE study did not meet its primary endpoint of superiority in [progression-free survival] compared to sunitinib for patients in the post-imatinib setting, the efficacy of Qinlock was comparable to sunitinib,” Dr. Sherman said.
“In addition, Qinlock had a more favorable safety profile than sunitinib with fewer Grade 3/4 adverse events, and patients in the Qinlock arm reported less deterioration in role functioning and better outcomes on several other key patient-reported outcome measures of tolerability compared to sunitinib.”
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The INTRIGUE trial included 453 patients with second-line GIST across 122 sites in 22 countries who were randomized to receive ripretinib or sunitinib. Ripretinib was generally well tolerated and showed a longer progression-free survival (8.3 months) than sunitinib (7 months), although this difference was not significant.
Patients taking ripretinib were less likely to experience grade 3/4 treatment-emergent adverse events than those taking sunitinib, and patients taking ripretinib reported less deterioration in their ability to participate in work and leisure activities during the treatment. Patients receiving sunitinib had a higher incidence of grade 3 hypertension and palmar-plantar erythrodysesthesia, and they more often reported a moderate or extremely large impact on their lives due to skin toxicity.
Bauer S, Jones RL, Blay JY, et al. Ripretinib versus sunitinib in patients with advanced gastrointestinal stromal tumor after treatment with imatinib (INTRIGUE): a randomized, open-label, phase III trial. J Clin Oncol. Published online August 10, 2022. doi:10.1200/JCO.22.00294
Deciphera Pharmaceuticals, Inc. announces publication of INTRIGUE phase 3 clinical study results in Journal of Clinical Oncology. News release. Deciphera Pharmaceuticals, Inc; August 10, 2022.