Ascentage Pharma Group International · HKEX:6855
Ascentage Pharma Group International — ESH-iCMLf 27th Annual John Goldman Conference on Chronic Myeloid Leukemia 2025
13 slides from Ascentage Pharma Group International's conference presentation, 2025
Slide 1: Olverembatinib (HQP1351) as second-line therapy in patients with CP-CML
Olverembatinib (HQP1351) as second-line therapy in patients with chronic phase- chronic myeloid leukemia (CP-CML) Weiming Li, MD,1 Yanli Zhang, MD,2 Huanling Zhu, MD,3 Yunfan Yang, MD,3 Na Xu, MD,4 Bingcheng Liu, MD,5 Zi Chen, MD, PhD,6 Wei Chu,6 Yifan Zhai, MD, PhD,6.7 and Yu Hu, MD1 1Department of
Slide 2: Disclosures of Commercial Support
DISCLOSURES OF COMMERCIAL SUPPORT Research Speaker’s Scientific Name of company Employee Consultant Stockholder support Bureau Advisory Board Ascentage Pharma Group Funding / / / / / Corp Ltd (Hong Kong) Presented by Prof. Weiming Li ESH-iCMLf 27th Annual John Goldman Conference on Chronic Myeloid L
Slide 3: Introduction
INTRODUCTION • Several second- and third-line tyrosine kinase inhibitors (TKIs) are available for patients with CP-CML without the BCR::ABL1 T315I mutation, with 1-year complete cytogenetic response (CCyR) rates of 30% to 40% (20%-30% with second-generation TKIs in the first line) and major molecula
Slide 4: Methods
METHODS Study design: This is a multicenter, open-label, phase 2 study designed to assess the efficacy and safety of olverembatinib in second-line treatment of patients with CP-CML. Key inclusion criteria: • ≥ 18 years of age • CP-CML diagnosis Endpoints • Received 1 TKI Olverembatinib • Primary: CC
Slide 5: Results: Patient Characteristics
RESULTS: Patient Characteristics N = 43 Age Median (range), yr 45.0 (19-70) Sex, n (%) Female 13 (30.2) Male 30 (69.8) ECOG PS, n (%) 0 41 (95.3) 1 2 (4.7) Time from diagnosis to start olverembatinib, yr Median time (range) 1.12 (0.3-21.1) First-line treatment, n (%) Imatinib 12 (27.9) Nilotinib 11
Slide 6: Results: Patient Characteristics and Disposition
RESULTS: Patient Characteristics and Disposition N = 43 Resistant or intolerant to 1L treatment, n (%) Resistant 40 (93.0) Intolerant 3 (7,0) Mutation statusa, n (%) No mutation detected 32 (74.4) 1 mutation 7 (16.3) 2 mutations 2 (4.7) 3 mutations 2 (4.7) Treatment discontinuation, n (% of total) A
Slide 7: Results: Best Responses with Olverembatinib Treatment
RESULTS: Best Responses with Olverembatinib Treatment 100% 88.2% (15/17) 90% 85.2% (23/27) 80% 74.1% (20/27) 70% 60% • At the data cutoff date, 33 pts 50% had undergone ≥1, 28 ≥2, and 40.6% (13/32) 23 ≥3 efficacy assessments. 40% 30% • The median follow-up (range) was 16.0 (2-18) months. 20% 10% • O
Slide 8: Results: Subgroup Analysis
RESULTS: Subgroup Analysis Imatinib (Ima) vs. second-generation (2G) TKIs as first-line treatment 90% CCyR MMR In 33 efficacy-evaluable patients: 78.9% (15/19) 80% • Of 24 patients pretreated with 2G TKIs* as 1L treatment, 78.9% 70% achieved CCyR, and 43.5% 60% achieved MMR. 50.0% (4/8) • Of 9 patie
Slide 9: Results: Subgroup Analysis
RESULTS: Subgroup Analysis Baseline BCR-ABL International Scale (IS) 120% CCyR MMR 100.0% (4/4) When patients were grouped 100% according to baseline BCR-ABL IS: 80% • Patients with BCR-ABL IS <10% 69.6%(16/23) achieved CCyR in 100% of cases and MMR in 50% of cases. 60% 50.0% (4/8) • Patients with B
Slide 10: Results: Subgroup Analysis
RESULTS: Subgroup Analysis BCR::ABL1 mutation status 100% CCyR MMR According to baseline 85.7% (6/7) BCR::ABL1 mutation 80% status*: 65.0% (13/20) • In patients with no 60% 55.6% (5/9) mutation, 65.0% achieved CCyR, and 34.8% achieved MMR. 40% 34.8% (8/23) • In patients with 20% mutations, 85.7% ach
Slide 11: Results: Safety Profile
RESULTS: Safety Profile All Grade TRAEs (incidence ≥ 10%) Haematologic Grade1-2 Platelet count decreased Grade3-4 Treatment-Related Serious Adverse Events Anaemia Neutrophil count decreased Preferred term White blood cell count decreased Population 43 Nonhaematologic Skin hyperpigmentation Serious a
Slide 12: Conclusions
CONCLUSIONS • This is the first report of olverembatinib administered as a second-line TKI therapy in patients with CML. • Olverembatinib demonstrated efficacy in patients with CP-CML with non-T315I mutations resistant or intolerant to prior first-line TKI treatment. Olverembatinib resulted in a CCy
Slide 13: Acknowledgments
ACKNOWLEDGMENTS • We wish to thank the study team, investigators, and especially the participating patients and their families. Presented by Prof. Weiming Li ESH-iCMLf 27th Annual John Goldman Conference on Chronic Myeloid Leukemia 2025