page created 5/18/2020

Qinlock Approved for 4th Line GIST Treatment May 15, 2020

QinlockTM (ripretinib) (Deciphera Pharmaceuticals, LLC) was approved by the FDA for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

Efficacy was evaluated in INVICTUS (NCT03353753), an international, multi-center, randomized (2:1), double-blind, placebo-controlled trial in 129 patients with GIST who were previously treated with imatinib, sunitinib, and regorafenib. Patients received ripretinib 150 mg or placebo orally once daily until disease progression or unacceptable toxicity. Crossover was permitted at disease progression for patients randomized to receive placebo.

The trial demonstrated a statistically significant improvement in PFS for patients in the ripretinib arm compared with those in the placebo arm (HR 0.15; 95% CI: 0.09, 0.25; p<0.0001). The median PFS was 6.3 months (95% CI: 4.6, 6.9) for ripretinib compared with 1.0 month (95% CI: 0.9, 1.7) for placebo.

The median OS in the ripretinib arm was 15.1 months (95% CI: 12.3, 15.1) compared with 6.6 months (95% CI: 4.1, 11.6) in the placebo arm with a HR of 0.36 (95% CI: 0.21, 0.62), though OS was not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints (i.e., PFS, then ORR, then OS).

The recommended dosage is 150 mg orally once daily with or without food.

You may have questions about this treatment. As always, please consult your GIST specialist to determine if this is a potential treatment option for you. Our Patient Registry staff is happy to answer questions about avapritinib and other approved treatment options for GIST. Please contact Sahibjeet Kaur at skaur@liferaftgroup.org

Qinlock was developed by Deciphera Pharmaceuticals. Access press release here.

Prescribing information

A guide for patients is available at https://www.qinlock.com/ and financial assistance.

Core Values