In part 1 of the phase 3 Peak trial, which was presented at the 2023 ASCO Annual Meeting, bezuclastinib in combination with sunitinib was found to have a tolerable safety profile, as well as early signs of clinical activity in those with gastrointestinal stromal tumors (GIST). The aim of part 1a of the trial was to locate the optimal formulation of the combination that accomplished target drug exposures found in the prior phase 1/2 clinical data in patients with GIST with this combination. Part 1b of the study included about 20 patients and investigated either bezuclastinib or sunitinib alone for 2 weeks followed by bezuclastinib plus sunitinib. Part 2 aims to include 388 patients to be randomly assigned 1:1 to bezuclastinib plus sunitinib at the selected dose or daily sunitinib alone at 37.5 mg. Safety and pharmacokinetic information from part 1 of study is outlined in the link below.
Reference: Wahner A. Bezuclastinib Plus Sunitinib Shows Encouraging Safety and Efficacy Profile in R/R Second-Line GIST. OncLive. Published October 25, 2023. Accessed January 12, 2024. https://www.onclive.com/view/bezuclastinib-plus-sunitinib-shows-encouraging-safety-and-efficacy-profile-in-r-r-second-line-gist
