EHA 2024: Ascentage Pharma Updates Lisaftoclax Data Showing Improved ORR in R/R MM and AL Amyloidosis

June 18, 2024—Ascentage Pharma, a global biopharmaceutical company focused on creating new treatments for cancer, chronic hepatitis B (CHB), and age-related diseases, has announced updated findings for its Bcl-2 inhibitor lisaftoclax (APG-2575). The data was presented at the 2024 European Hematology Association Hybrid Congress (EHA 2024) in Madrid, Spain. This update follows initial results showcased at the 2023 American Society of Hematology Annual Meeting.

The new data reaffirm the promising efficacy and favorable safety profile of lisaftoclax when used in combination therapies, particularly with pomalidomide and dexamethasone in patients with relapsed/refractory (R/R) multiple myeloma (MM). The study also highlighted a 14.3% incidence of Grade 3 or higher treatment-related neutropenia, indicating the potential of these regimens to offer a safer treatment alternative for patients.

"This study of lisaftoclax combined with novel therapeutic regimens in patients with R/R MM or AL amyloidosis shows promising results," stated Prof. Sikander Ailawadhi, MD, from Mayo Clinic and the study's principal investigator. "The combination of lisaftoclax and pomalidomide in R/R MM showed a very good partial response (VGPR) rate of 33.3%, with increasing efficacy at higher doses. Additionally, this combination therapy was well tolerated, with a Grade 3/4 neutropenia rate of 14.3%. This data could provide new treatment options for patients."

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, added, "We're thrilled to present these updated results at EHA 2024. The findings highlight the excellent safety and efficacy of lisaftoclax combination therapies, underlining their global best-in-class potential. We are committed to advancing this clinical development program to deliver a safe and effective treatment to patients as quickly as possible."

The EHA Hybrid Congress is a significant event in the hematology field, attracting over 10,000 experts and researchers annually. In addition to the latest data on lisaftoclax, Ascentage Pharma also presented findings on the third-generation BCR-ABL1 inhibitor olverembatinib (HQP1351) and the EED inhibitor APG-5918.

Key data on lisaftoclax presented at the congress include:

- Study Background: R/R MM, an incurable condition with inevitable relapse, and AL amyloidosis, a rare disease leading to severe organ damage or death, were the focus. Lisaftoclax, a novel BCL-2 inhibitor, has shown clinical benefits in various cancers with minimal adverse events.
- Study Design: The multicenter study evaluated the safety and efficacy of lisaftoclax combined with pomalidomide and dexamethasone (Arms A and C) or daratumumab, lenalidomide, and dexamethasone (Arm B) in patients with R/R MM or AL amyloidosis.
- Patient Demographics: 44 patients (36 with R/R MM and 8 with AL amyloidosis) were enrolled, with a median age of 70.5 years. Most had undergone multiple prior therapies.
- Efficacy Results: In Arm A, 70.4% of patients with R/R MM showed an overall response rate (ORR), with some achieving complete responses. In Arm C, 85.7% of AL amyloidosis patients showed a positive response.
- Safety Results: Among 42 patients analyzed for safety, 10 experienced Grade ≥3 treatment-related adverse events, including neutropenia (14.3%) and serious adverse events like febrile neutropenia and acute kidney injury.

In summary, the study concluded that lisaftoclax plus novel therapeutic regimens is well tolerated and demonstrates significant anti-tumor activity in patients with R/R MM and AL amyloidosis.

Ascentage Pharma continues to focus on innovative therapies for unmet medical needs globally and is advancing its clinical programs to bring new treatment options to patients worldwide.

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