ASCO 2024: Ascentage Pharma Unveils New Clinical Results for Lead Drug Candidates

SUZHOU, China and ROCKVILLE, Md., May 23, 2024 -- Ascentage Pharma (6855.HK), a global biopharmaceutical company specializing in innovative therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, has publicized four of its abstracts selected for presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. These abstracts, now accessible on ASCO's official website, discuss the company's three leading drug candidates: olverembatinib (HQP1351), lisaftoclax (APG-2575), and APG-2449.

Olverembatinib (HQP1351) is the first and only third-generation BCR-ABL inhibitor approved in China. Lisaftoclax (APG-2575) is a BCL-2 selective inhibitor, and APG-2449 is an inhibitor that targets FAK/ALK/ROS1. The updated results from these studies will be shared through Oral Reports or Posters from May 31 - June 4, 2024, in Chicago, IL, during the ASCO Annual Meeting, which is celebrated for presenting the most recent breakthroughs in clinical oncology.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, expressed enthusiasm about presenting their latest findings at ASCO for the seventh consecutive year. He emphasized that these results underscore Ascentage Pharma's strength in global innovation and clinical development. Dr. Zhai mentioned the company's plans to accelerate clinical development globally to benefit more patients in China and worldwide.

The following are the key studies to be presented at the meeting:

Oral Report: Olverembatinib (HQP1351)
- Title: Updated efficacy results of olverembatinib in patients with TKI-resistant SDH-deficient GIST and paraganglioma
- Abstract#: 11502
- Session Title: Sarcoma
- Date and Time: June 3, 2024, 3:00 PM – 6:00 PM (Central Time)
- First Author: Haibo Qiu, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, China.

Study Highlights:
SDH-deficient GIST is a rare variant mostly found in younger patients. Olverembatinib, already approved in China for chronic myeloid leukemia, has shown promising efficacy in this condition. The study aimed to evaluate olverembatinib's safety and efficacy in SDH-deficient GIST and other tumors. Results showed a high clinical benefit rate (CBR) of 92.3% in GIST patients and 83.3% in paraganglioma patients, with a median progression-free survival (PFS) of 25.7 months for GIST and 8.25 months for paraganglioma.

Poster Presentations:

Lisaftoclax (APG-2575)
1. Title: Safety and efficacy of lisaftoclax in combination with azacitidine in patients with treatment-naïve or relapsed/refractory acute myeloid leukemia
- Abstract#: 6541
- Session Title: Hematologic Malignancies
- Date and Time: June 3, 2024, 9:00 AM – 12:00 PM (Central Time)
- First Author: Huafeng Wang, MD, PhD, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.

Study Highlights:
In this study, lisaftoclax combined with azacitidine showed an overall response rate (ORR) of 72.7% in relapsed/refractory AML patients and 64.1% in treatment-naïve AML patients. The 600 mg dose was established as the recommended Phase II dose (RP2D).

2. Title: Efficacy and safety results of lisaftoclax alone or combined with ibrutinib or rituximab in patients with Waldenström macroglobulinemia
- Abstract#: 7078
- Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
- Date and Time: June 3, 2024, 9:00 AM – 12:00 PM (Central Time)
- First Author: Masa Lasica, MBBS, FRACP, FRCPA, St Vincent's Hospital, Melbourne, Australia.

Study Highlights:
Lisaftoclax, both alone and in combination with ibrutinib or rituximab, was well tolerated and showed notable clinical activity in patients with treatment-naïve or relapsed/refractory Waldenström macroglobulinemia.

APG-2449
- Title: Updated study results of novel FAK/ALK/ROS1 inhibitor APG-2449 in NSCLC patients resistant to second-generation ALK inhibitors
- Abstract#: 3124
- Session Title: Developmental Therapeutics
- Date and Time: June 1, 2024, 9:00 AM – 12:00 PM (Central Time)
- First Author: Yuxiang Ma, MD, PhD, Sun Yat-sen University Cancer Center, Guangzhou, China.

Study Highlights:
APG-2449 demonstrated preliminary efficacy in both ALK and ROS1 TKI-naïve NSCLC patients and those resistant to second-generation ALK TKIs. It showed significant activity, particularly in brain metastases, with a correlation between high baseline pFAK levels and improved treatment responses.

Ascentage Pharma is committed to developing innovative therapies to meet unmet medical needs globally. The company is focused on targeting protein-protein interactions to restore apoptosis and has built a robust pipeline of clinical drug candidates while collaborating with leading biotech and pharmaceutical organizations worldwide.

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