Efficacy and Safety of Ripretinib in Chinese Patients with Advanced Gastrointestinal Stromal Tumors as a fourth- or later-line therapy
Mené en Chine sur 39 patients atteints d'une tumeur stromale gastro-intestinale de stade avancé, cet essai de phase II évale l'efficacité, du point de vue de la survie sans progression, et la toxicité du riprétinib en traitement de 4ème ligne ou au-delà
Purpose: This is a phase 2 multicenter, single-arm, open-label study assessing the efficacy, safety and pharmacokinetics of ripretinib in Chinese patients with advanced gastrointestinal stromal tumor (GIST) as a fourth- or later-line therapy. It was designed to show consistency with the phase 3 INVICTUS study. Experimental Design: Patients with disease progression on (or intolerance to) prior imatinib, sunitinib, and at least one other drug were recruited to receive ripretinib 150 mg once daily (QD) continuously in 28-day cycles. The primary endpoint was progression-free survival (PFS) based on independent radiologic review (IRR). Secondary efficacy endpoints included objective response rate (ORR) based on IRR and overall survival. Safety endpoints included the incidence and severity of AEs. Results: Between April 2020 and August 2020, 39 patients were enrolled. All were included in the safety analysis while 38 were in the efficacy analysis. By primary data cutoff (26 February 2021), the mPFS (90% CI) was 7.2 (2.9, 7.3) months; the lower bound of the 90% CI exceeded 1 month, fulfilling the standard of bridging success. The ORR (95% CI) based on IRR was 18.4% (7.7%, 34.3%). Treatment-related treatment-emergent adverse events (TRAEs) were reported in 37 (94.9%) patients. The majority of TRAEs were of Grade 1/2. A total of 6 patients (15.4%) experienced Grade 3/4 TRAEs. Conclusions:The results demonstrated that ripretinib can clinically improve the outcomes of Chinese patients with advanced GIST as a fourth- or later-line therapy. The efficacy, safety and pharmacokinetics profiles of ripretinib are consistent with those in the global patient population.