Ripretinib (Qinlock ®) leads to substantial clinical benefit in patients with gastrointestinal stromal tumor (GIST) with a KIT exon 11 and 17/18 mutations previously treated with sunitinib, according to an exploratory data analysis from a phase 3 clinical trial called INTRIGUE. 

“The newly reported clinical results from INTRIGUE demonstrate the remarkable differential benefit of ripretinib in patients with unique molecular subtypes of GIST in the second-line setting,” said  Suzanne George, MD, the colead investigator on the INSIGHT study and associate division chief of the Sarcoma Center at the Dana Farber Cancer Institute. 

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INTRIGUE is a randomized, global, multicenter, open-label study evaluating the safety and efficacy of ripretinib compared to sunitinib in 453 patients with GIST who have previously been treated with ripretinib.

The objective of the exploratory data analysis was to evaluate the anti-tumor efficacy of ripretinib according to the baseline primary and secondary KIT mutation status of the patients. Of the 453 patients, 362 patients had samples that were suitable for evaluation, and of those, 280 (77.3%) had circulating tumor DNA in their blood, while 213 (58.8%) had KIT mutations.

The investigators found that patients with a KIT exon 11 and exon 17/18 only mutation had substantially better progression-free survival, objective response rate, and overall survival with ripretinib treatment compared to sunitinib treatment.

Based on these results, Deciphera Pharmaceuticals, the makers of Qinlock plans to initiate a pivotal phase 3 clinical trial of ripretinib versus sunitinib in second-line patients with GIST with KIT exon 11 and 17/18 only mutations.

“If positive, we believe this trial will transform the standard of care for this subgroup of second-line GIST patients based on their mutational profile,” said the chief medical officer of Deciphera, Matthew L. Sherman MD.

Ripretinib is a type 2 switch control tyrosine kinase inhibitor that is already the standard of care for the 4th line treatment of patients with GIST.

Reference

Deciphera Pharmaceuticals announces results from ctDNA analysis from INTRIGUE phase 3 clinical study demonstrating substantial clinical benefit of QINLOCK® in second-line GIST patients with mutations in KIT exon 11 and 17/18 only. News release. Deciphera Pharmaceuticals; January 3, 2023