#FUSION 360 PERSONAL TRIAL#
The STARTRK-2 trial was a basket study that included with patients with solid tumors harboring NTRK 1/2/3, ROS1, or ALK gene fusions. Two dose-limiting toxicities occurred in the trial at a daily dose of 800 mg. The most common tumor type was NSCLC.Īll patients received continuous daily dosing of study treatment for 28 days. Additionally, 34% of prior treatments were ROS1/ALK inhibitors. Prior systemic therapies were used in 39% of patients and ranged between 3 to 4 lines. The median age of patients (n = 65) was 57, a majority were male, and 63% had an ECOG performance status of 1. The secondary end points were plasma concentrations of entrectinib, disease control, duration of response (DOR), overall survival, and progression-free survival. The primary end points included dose-limiting toxicities, maximum tolerated dose, recommended phase 2 dose, and overall response rate. Patients with TrkA, TrkB, TrkC, ROS1, and ALK molecular alterations were treated with entrectinib as part of the STARTRK-1 trial. Of those receiving 800 mg dose level, 1 patient had grade 4 eosinophilic myocarditis. No patients experienced dose-limiting toxicities, with grade 3 cognitive disturbance and fatigue being resolved with dose interruption. The most common adverse effects (AEs) included fatigue (46%), dysgeusia (42%), paresthesia (29%), nausea (28%), and myalgia (23%). The most common tumor type was NSCLC.įor the trial, the dose schedules included 19 patients on schedule A, which had patients fast followed by 4 days of entrectinib and 3 days off for 21 of 28 days 29 patients were on schedule B who were fed and received continuous dosing for 28 days and 6 patients were on schedule C who were fed followed by 4 days on the study treatment and 3 days off for 28 days. 2 In 94% of patients received 4 or more prior systemic therapies, and 19% had prior ROS1/ALK inhibitors. The majority were male, and 56% had an ECOG performance status of 0. “This approval marks a significant step forward in expanding treatment options and improving outcomes for patients, particularly those with rare tumors.”Ī total of 54 patients with advanced or metastatic solid tumors enrolled on the ALKA-372-001 trial, with a median age of 53 years. “The ability to tailor cancer therapies based on specific genomic alterations using validated comprehensive genomic profiling (CGP) has transformed the traditional ‘one-size fits all’ approach to cancer,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Roche, said in the press release.
As part of the approval, the FDA has added a condition where a post-approval study must be conducted by the Flatiron Health-Foundation Medicine’s Clinico-Genomic Database to continue to identify patients with ROS1 fusion-positive NSCLC who would benefit from entrectinib. The approval is based on findings from several studies, including the phase 1 ALKA-372-001, phase 1 STARTRK-1 (NCT02097810), and phase 2 STARKTRK-2 (NCT02568267) trials. The FDA has approved FoundationOne CDx as a companion diagnostic for entrectinib (Rozlytrek), for patients with ROS1 fusion–positive non–small cell lung cancer (NSCLC) or NTRK fusion–positive solid malignancies, according to a press release from Roche.
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