Long-Term INTRIGUE Study Results for Second-Line GIST Presented at 2024 ASCO GI Cancers Symposium

Deciphera Pharmaceuticals, a company dedicated to developing cancer treatments, has reported new findings from the INTRIGUE Phase 3 clinical trial. The study compared the effectiveness of QINLOCK® (ripretinib) against sunitinib in advanced gastrointestinal stromal tumor (GIST) patients who had previously been treated with imatinib.

The research, led by John Zalcberg, M.D., Ph.D., from Monash University in Australia, showed that the median overall survival for QINLOCK was 35.5 months, slightly longer than the 31.5 months for sunitinib in the all-patient intent-to-treat population. Additionally, QINLOCK exhibited a more favorable long-term safety profile, with fewer patients experiencing grade 3/4 treatment-emergent adverse events (TEAEs) and a lower rate of treatment discontinuations due to TEAEs.

Matthew L. Sherman, M.D., Chief Medical Officer at Deciphera, highlighted that the final results from INTRIGUE underscore QINLOCK's strong clinical activity in the second-line GIST patient population. Importantly, the data indicated that third-line treatments were not negatively impacted by prior treatment with QINLOCK in the second line.

In the INTRIGUE trial, 453 patients with second-line GIST were randomly assigned to receive either QINLOCK 150 mg once daily or sunitinib 50 mg once daily. Although the primary endpoint was not achieved, QINLOCK demonstrated a median progression-free survival of 8.0 months, similar to sunitinib's 8.3 months. Notably, QINLOCK was associated with a significantly lower rate of Grade 3/4 drug-related TEAEs.

The final analysis, which included 18 months of additional follow-up, confirmed the overall survival findings and the safety and tolerability profile of QINLOCK. The most common TEAEs with QINLOCK were alopecia, fatigue, and myalgia, while sunitinib was associated with palmar-plantar erythrodysesthesia syndrome, diarrhea, and hypertension.

An exploratory analysis of the efficacy of the next line of therapy revealed a similar median progression-free survival for QINLOCK and sunitinib. After treatment discontinuation, the most common third-line therapy was sunitinib for QINLOCK patients and regorafenib for sunitinib patients.

Deciphera Pharmaceuticals is leveraging its switch-control kinase inhibitor platform to develop a range of innovative cancer medicines. QINLOCK, a switch-control inhibitor for the treatment of fourth-line GIST, is already approved in several countries including Australia, Canada, China, the European Union, and the United States.

The company is also enrolling the INSIGHT pivotal Phase 3 clinical study, which will evaluate QINLOCK's efficacy and safety in second-line GIST patients with specific KIT exon mutations. This follows an exploratory ctDNA analysis from INTRIGUE that showed substantial clinical benefits of QINLOCK compared to sunitinib in these patients.

Deciphera Pharmaceuticals is committed to improving the lives of cancer patients through the discovery, development, and commercialization of new medicines. The company's focus on kinase biology and innovative drug development platforms positions it at the forefront of cancer treatment research.