Suzhou-based Ascentage Pharma (HKG: 6855) has announced its intention to present the clinical results of its four oncology drugs, including olverembatinib, Bcl-2 inhibitor APG-2575, MDM2-p53 inhibitor APG-115, and FAK/ALK/ROS1 triple inhibitor APG-2449, at an upcoming medical conference.
Phase I Study for APG-2449 in Solid Tumors
An open, multicenter, dose escalation, and dose expansion Phase I clinical study has been conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of APG-2449 in solid tumor patients, particularly those with ALK/ROS1 positive NSCLC. As of December 9, 2022, the study demonstrated promising results in terms of objective response rate (ORR) and disease control rate (DCR) among ROS1 positive and ALK positive NSCLC patients. The drug also showed an ability to inhibit FAK phosphorylation.
Phase Ib/II Study for Olverembatinib in SDH Deficient GIST Patients
As of January 15, 2023, the median treatment time for 20 SDH deficient GIST patients was 7.8 months, with 5 patients achieving partial response (PR). The clinical benefit rate (CBR) reached 93.8% among patients treated for over 16 weeks. The study reported a good tolerance profile for olverembatinib at a dosage of 50mg QOD, showing promising anti-tumor activity in TKI-resistant SDH deficient GIST patients.
Phase Ib/II Study for APG-2575 in Waldenstrom Macroglobulinemia (WM) Patients
As of January 25, 2023, a total of 46 patients were enrolled in the study, divided into three groups based on treatment regimens. The study showed varying response rates and median time to remission (MTTR) across the groups, with no negative impact of CXCR4 mutation on efficacy observed. APG-2575, whether as a monotherapy or in combination with ibrutinib or rituximab, demonstrated effectiveness in WM patients who had failed initial or previous BTKi treatment.
Phase II Clinical Study of APG-115 Combined with Pembrolizumab in Skin Melanoma Patients
As of December 12, 2022, out of 26 patients evaluable for efficacy, 2 achieved complete response (CR) and 4 achieved PR, resulting in a confirmed ORR of 23.1%. The study reported a high incidence of treatment-related adverse events (TRAEs), with 30 patients (96.8%) reporting TRAEs and 4 patients (12.9%) reporting severe TRAEs. The combination of APG-115 and pembrolizumab showed good tolerance and strong anti-tumor activity in patients with skin melanoma who had failed immuno-oncology (IO) treatment.-Fineline Info & Tech
