GenFleet-B (02595) announced that preliminary data from a study of GFH276, an oral molecular glue pan-RAS inhibitor, in patients with previously treated RAS-mutant solid tumors were presented on October 25 local time as a breakthrough abstract and on-site oral presentation at the ESMO (European Society for Medical Oncology) Annual Congress.
GFH276 has shown encouraging preliminary efficacy and a favorable safety profile in the dose-escalation phase: partial responses (PR) were observed starting at the 40 mg QD dose level; no dose-limiting toxicities (DLTs) were observed at the 40-160 mg QD dose levels in patients who did not receive prophylactic medication.
In the Phase Ia trial, 72.6% of patients with pancreatic ductal adenocarcinoma (PDAC) and 61.1% of patients with non-small cell lung cancer (NSCLC) received GFH276 monotherapy as third-line or later treatment after enrollment. As of the data cutoff date, among 61 evaluable PDAC patients (40-160 mg QD), the overall objective response rate (ORR) was 41.1%, and the ORR was 43.1% in PDAC patients who had not previously received RAS-targeted therapy; among 11 evaluable NSCLC patients (80-160 mg QD), the overall ORR was 45.5%, and the ORR was 55.6% in NSCLC patients who had not previously received RAS-targeted therapy.
Dr. Wang Yu, Chief Medical Officer of GenFleet, said: "This is the first time that human trial data for GFH276 have been released at an international academic conference. The preliminary data demonstrate excellent efficacy and a relatively wide therapeutic window, supporting mid- to late-stage clinical research of monotherapy and various combination therapies (combined with EGFR monoclonal antibodies, or chemotherapy, etc.). The successful launch of overseas products targeting the same pathway validates the clinical value and market prospects of pan-RAS inhibitors; GenFleet's pipeline includes a marketed KRAS G12C inhibitor, a KRAS G12D inhibitor with a globally leading monotherapy clinical progress, and a RAS therapy matrix with diverse targets, molecular types, and treatment regimens. We look forward to bringing more treatment options to patients with RAS mutations through innovative monotherapy and combination regimens."
Comments