Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) has announced that Nature Medicine has published the results of a circulating tumor DNA (ctDNA) analysis from the INTRIGUE Phase 3 study of QINLOCK (ripretinib). The study focused on gastrointestinal stromal tumor (GIST) patients with mutations in KIT exon 11 and 17/18 who had previously been treated with imatinib.
The article, titled Ripretinib versus sunitinib in gastrointestinal stromal tumor: ctDNA biomarker analysis of the phase 3 INTRIGUE trial, discusses the findings of the study and their potential implications for GIST treatment. The article, which is now available online, will also be published in a future print issue of Nature Medicine.
The results of the study show that QINLOCK may provide a progression-free and overall survival benefit to second-line GIST patients with specific genetic mutations. This analysis may allow for a more personalized treatment plan for individuals living with GIST.
The results published in Nature Medicine provide compelling evidence that QINLOCK may provide progression-free and overall survival benefit to second-line (2L) GIST patients in whom a liquid biopsy reveals primary KIT exon 11 mutations plus secondary mutations restricted to KIT exons 17 and 18, said Sebastian Bauer, M.D., Medical Oncologist at the West German Cancer Center in Essen and senior author of the study.
The study found that treatment with QINLOCK resulted in a 78% reduction in the risk of disease progression and a 66% reduction in the risk of death compared to sunitinib in second-line GIST patients with specific genetic mutations.
Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera, stated, In second-line GIST patients with KIT exon 11 + 17/18 mutations only, treatment with QINLOCK resulted in a 78% reduction in the risk of disease progression and a 66% reduction in the risk of death compared to sunitinib, representing a substantial clinical benefit for these patients.
The INTRIGUE Phase 3 study was conducted in 122 active sites across 22 countries with 453 patients in the all patient intent-to-treat population (AP-ITT) with second-line GIST. The study randomized patients to receive either ripretinib or sunitinib.
While the study did not achieve the primary efficacy endpoint of progression-free survival (PFS), the results from the ctDNA analysis provide important insights into the potential benefits of QINLOCK for specific patient populations. QINLOCK has been included in the National Comprehensive Cancer Network Clinical Practice Guidelines as the preferred second-line regimen for advanced GIST patients who are intolerant to sunitinib.
Deciphera is currently conducting the INSIGHT Phase 3 study to confirm the efficacy observed in the INTRIGUE exploratory analysis. The study is open at multiple sites, and the company is committed to enrolling patients as quickly as possible.
The results of the ctDNA analysis offer hope for more targeted and optimized treatment plans for GIST patients. By using sensitive and minimally invasive blood tests to identify specific genetic profiles, healthcare providers may be able to tailor therapy based on the differential activity of QINLOCK and sunitinib.
As the study results provide insight into the potential benefits of QINLOCK, the field of GIST treatment continues to evolve. Further research and clinical trials will be necessary to fully understand the extent of QINLOCK’s impact on GIST patients with specific genetic mutations.
Overall, the publication of the ctDNA analysis results in Nature Medicine represents an important advancement in the field of GIST treatment. The findings highlight the potential of QINLOCK to provide a meaningful clinical benefit to GIST patients with specific genetic mutations, bringing hope to those living with this disease.
