Zhitong Finance App News, Jingfang Pharmaceutical-B (02595) issued an announcement. Preliminary research data on GFH276 (an oral molecular gum RAS inhibitor) for treating solid tumors with RAS mutations appeared in the groundbreaking research summary and live oral report at the ESMO (European Society of Medical Oncology) Annual Meeting on October 25, local time. GFH276 has shown encouraging initial efficacy and good safety during the dose escalation phase: partial remission (PR) can be observed in patients from the 40 mg QD dose level; no dose-limiting toxicity (DLTs) was observed at the 40-160 mg QD dose level when patients were not using prophylactic agents.
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 as a single agent as line 3 or above after enrolling. As of the data cutoff date, the overall objective response rate (ORR) for 61 evaluable PDAC patients (40-160 mg QD) was 41.1%, the ORR for PDAC patients who had not previously received RAS targeted therapy was 43.1%; the overall ORR for 11 evaluable NSCLC patients (80-160 mg QD) was 45.5%, and the ORR of NSCLC patients who had not previously received RAS targeted therapy was 55.6%.
Dr. Wang Yu, Chief Medical Officer of Jingfang, said, “This is the first time that GFH276 human trial data was presented at an international academic conference. The preliminary data showed excellent efficacy and a wide treatment window, and supported mid to late clinical studies of single drugs and multiple combination therapies (combined EGFR monoclonal antibodies, or chemotherapy, etc.). The successful launch of same-target products overseas has verified the clinical value and market prospects of pan-RAS inhibitors; Jingfang Pipeline has already marketed KRAS G12C inhibitors, KRAS G12D inhibitors with leading global single-drug clinical progress, and a RAS therapy matrix with multiple targets, molecular types, and treatment plans. We look forward to bringing more treatment options to patients with RAS mutations through innovative single drugs and combination solutions.”