Deciphera presents long-term follow-up results from INTRIGUE Phase 3 trial

Deciphera Pharmaceuticals announced the presentation of new long-term results from the INTRIGUE Phase 3 clinical study comparing QINLOCK versus sunitinib in patients with advanced gastrointestinal stromal tumor previously treated with imatinib. The presentation titled “Overall survival and long-term safety with ripretinib vs sunitinib in patients with advanced gastrointestinal stromal tumor previously treated with imatinib: final analyses from INTRIGUE” will be presented by John Zalcberg, M.D., Ph.D., Cancer Research Program, Monash University School of Public Health and Preventive Medicine and Department of Medical Oncology, Alfred Health, Melbourne, Victoria, Australia at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium. Results of INTRIGUE Study Long-Term Follow-Up: In INTRIGUE, 453 patients in the all-patient intent-to-treat population with second-line GIST were randomized 1:1 to receive QINLOCK 150 mg once daily or sunitinib 50 mg once daily of which 444 patients received treatment. In the primary analysis of the AP-ITT population based on a data cut of September 1, 2021, while the primary endpoint was not achieved, QINLOCK demonstrated similar efficacy with a median progression-free survival of 8.0 months versus 8.3 months for sunitinib. There were fewer patients with Grade 3/4 drug-related treatment emergent adverse events with QINLOCK compared with sunitinib. Based on the primary results from the INTRIGUE study, QINLOCK was included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for GIST as a preferred second-line regimen for patients with advanced GIST who are intolerant to sunitinib . The final analysis includes 18 months of additional follow up after the primary analysis based on a data cut of March 15, 2023. Key highlights from the final results presented include the following: Overall Survival: There were 211 OS events in the AP-ITT population with median duration of follow-up in the QINLOCK and sunitinib arms of 35.1 months and 34.1 months, respectively. Median OS in the AP-ITT population was similar with QINLOCK versus sunitinib. Safety and Tolerability: Among the 444 patients treated, 9.0% of patients remained on treatment at the time of data cutoff including 12.6% of 223 patients treated with QINLOCK and 5.4% of 221 patients treated with sunitinib. The long-term safety profile of QINLOCK was consistent with the primary analysis. Fewer patients had Grade 3/4 drug-related TEAEs with QINLOCK versus sunitinib. Dose interruptions and reductions as well as treatment discontinuations due to TEAEs were lower with QINLOCK versus sunitinib. Fewer patients discontinued treatment due to any TEAE for QINLOCK versus sunitinib. The most common TEAEs in the QINLOCK arm were alopecia, fatigue, and myalgia. The most common TEAEs in patients treated with sunitinib were palmar-plantar erythrodysesthesia syndrome, diarrhea, and hypertension. Exploratory Analysis: Efficacy of Next-Line Therapy: Median PFS on the next line of therapy after protocol treatment was similar for QINLOCK (7.7 months) versus sunitinib in the AP-ITT population. Following study treatment discontinuation, the most common third-line therapy was sunitinib for patients in the QINLOCK arm and regorafenib for patients in the sunitinib arm. Patients in the QINLOCK arm who received third-line sunitinib had a median PFS on next line of therapy of 8.5 months compared with 6.3 months for patients in the sunitinib arm who received third-line regorafenib.