SUZHOU, China, and ROCKVILLE, Md., Nov. 3, 2022 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the updated results from three studies of the company's novel drug candidate, olverembatinib (HQP1351), have been selected for oral presentations at the 64th American Society of Hematology (ASH) Annual Meeting. This is the fifth consecutive year in which studies of olverembatinib were selected for oral presentations at the ASH Annual Meeting, a growing recognition of the drug candidate's promising efficacy and safety by the international hematology community. It is worth noting that in this year, five studies of Ascentage Pharma's three drug candidates (olverembatinib, lisaftoclax, alrizomadlin), have been selected for presentations, including four oral presentations.
It is worth noting that these results selected for oral presentations at the ASH Annual Meeting also include the first batch of safety and efficacy data from the first US study of olverembatinib in patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). These interim results suggest that olverembatinib has promising efficacy and is well tolerated in patients with drug-resistant CML and Ph+ ALL, and has shown promising efficacy in patients who were ponatinib or asciminib resistant. Overall, these interim results signal olverembatinib's potential as the world's first next-generation BCR-ABL inhibitor that could overcome resistance to ponatinib or asciminib.
Additionally, data selected for the other two oral presentations include the updated results from a Phase II pivotal study of olverembatinib in patients with tyrosine kinase inhibitor (TKI)-resistant CML harboring the T315 mutation and the five-year follow-up data from a Phase I study in Chinese patients with TKI-resistant CML. These results further validate the promising safety and efficacy of olverembatinib.
The ASH Annual Meeting is one of the largest gatherings of the international hematology field, bringing together the latest and most cutting-edge scientific and clinical research in hematology. The 64th ASH Annual Meeting will take place on December 11-14, 2022, both online and in-person in New Orleans, the United States.
Developed by Ascentage Pharma, olverembatinib is a potential best-in-class novel drug that has been designated a Major New Drug Project by China's Ministry of Science and Technology. As the first approved third-generation BCR-ABL inhibitor in China and the second in any country globally, olverembatinib is recommended by both the Guidelines of the Chinese Society of Clinical Oncology (CSCO) and the China Anti-Cancer Association's (CACA) Guidelines for the Holistic Integrative Management of Cancers, for the treatment of patients with TKI-resistant CML harboring the T315I mutation (while the CACA Guidelines also recommend olverembatinib for the treatment of patients with CML intolerant/resistant to at least two TKIs).
Globally, despite the clinical adoption of other TKI, patients with CML still have enormous unmet medical needs due to the limited accessibility as well as adverse events, resulting in the strong interest in the clinical progress with olverembatinib from the global hematology community in recent years. At present, olverembatinib is being evaluated in a Phase Ib study in the US for the treatment of drug-resistant CML. Furthermore, olverembatinib has been granted one Fast Track designation and three Orphan Drug designations by the US Food and Drug Administration (FDA), and one Orphan Drug designation by the European Medicines Agency (EMA).
To address the unmet medical needs in patients with CML, Ascentage Pharma is pressing ahead with the global clinical development of olverembatinib and advancing the drug towards approvals in more countries. Driven by a sense of urgency to facilitate the early access by patients with malignancies that currently lack treatment options, Ascentage Pharma and Tanner Pharma Group, a global pharmaceutical services provider of specialty access solutions, jointly launched an innovative Named Patient Program (NPP) for olverembatinib in July 2022. This collaboration will allow access to olverembatinib on a named patient basis in over 140 countries and regions where the drug is not yet commercially accessible, in a manner that is reliable, responsible, ethical and in accordance with all country-specific regulatory requirements.
"For five consecutive years, results of olverembatinib have been selected for oral presentations at the ASH Annual Meeting, thus setting a new record signifying the growing recognition from the international hematology community," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "The first US data of olverembatinib showed the drug's potential as the world's first BCR-ABL inhibitor that can overcome the resistance to ponatinib and asciminib. We are encouraged by these results because they further validate that olverembatinib can potentially bring a long-awaited change to the treatment landscape in CML by effectively addressing the unmet needs of patients with CML globally. Moving forward, we will continue to accelerate the global clinical development of olverembatinib to fast track the drug towards approvals in overseas markets and more indications in China, with the hope of benefiting more patients around the world."
"We have also launched a Global Named Patient Program in 140 countries where the drug is not commercially available. The program makes Olverembatinib available to patients at the treating physician's decision in these countries", said Prof Dajun Yang, Chairman and CEO of Ascentage Pharma.
Drug Candidate
Abstract Title
Abstract#
Format
Olverembatinib
Olverembatinib (HQP1351) Overcomes
Ponatinib Resistance in Patients with Heavily
Pretreated/Refractory Chronic Myeloid
Leukemia (CML) and Philadelphia
Chromosome-Positive Acute Lymphoblastic
Leukemia (Ph+ ALL)
162387
Oral
Presentation
口头报告
Updated Results of Pivotal Phase 2 Trials of
Olverembatinib (HQP1351) in Patients (Pts)
with Tyrosine Kinase Inhibitor (TKI)-Resistant
Chronic- and Accelerated-Phase Chronic
Myeloid Leukemia (CML-CP and CML-AP) with
T315I Mutation
170698
Oral
Presentation
A Five-Year Follow-up on Safety and Efficacy of
Olverembatinib (HQP1351), a Novel Third-
Generation BCR-ABL Tyrosine Kinase Inhibitor
(TKI), in Patients with TKI-Resistant Chronic
Myeloid Leukemia (CML) in China
170868
Oral
Presentation
APG-2575
Lisaftoclax
Lisaftoclax (APG-2575) Safety and Activity As
Monotherapy or Combined with Acalabrutinib
or Rituximab in Patients (pts) with Treatment-
Naïve, Relapsed or Refractory Chronic
Lymphocytic Leukemia/Small Lymphocytic
Lymphoma (R/R CLL/SLL): Initial Data from a
Phase 2 Global Study
160386
Oral
Presentation
(APG-115)
Alrizomadlin
MDM2-p53 Inhibitor Alrizomadlin (APG-115)
Enhances Antitumor Activity of Pomalidomide
in Multiple Myeloma (MM)
162666
Poster
Presentation
The three abstracts of olverembatinib to be reported in oral presentations at this year's ASH Annual Meeting are as follows (for details of the oral presentation on lisaftoclax, please refer to a parallel press release):
Olverembatinib (HQP1351) Overcomes Ponatinib Resistance in Patients with Heavily Pretreated/Refractory Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Updated Results of Pivotal Phase 2 Trials of Olverembatinib (HQP1351) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI) -Resistant Chronic- and Accelerated-Phase Chronic Myeloid Leukemia (CML-CP and CML-AP) with T315I Mutation
As of the cutoff date of April 30, 2022, 41 patients were enrolled, of whom 21 (51.2%) were male, with a median age of 47 (range, 22-70) years. The median interval from CML diagnosis to first olverembatinib dose was 5.31 (range, 0.6-23.2) years, and 32 (78.1%) patients had received ≥ 2 prior TKIs. The median treatment duration was 32.7 (range, 3.1-36.7) months.
Preliminary efficacy: 100% of patients achieved complete hematologic response (CHR) (31/31, 10 others had CHR at baseline), 34/41 (82.9%) had a major cytogenetic response (MCyR), 29/41 (70.7%) CCyR, and 24/41 (58.5%) MMR. Median time to CHR was 1 (95% CI: 1.0-1.9) month, median time to MCyR was 2.8 (95% CI: 2.8-5.6) months, and median time to MMR was 6.5 (95% CI: 2.8 to not reached [NR]) months. At 36 months, the progression-free survival (PFS) rate was 86.3% (95% CI: 70.2%-94.1%) and the overall survival (OS) rate was 95.1% (95% CI: 81.9%-98.8%). A total of 5 patients withdrew because of PD, 4 intolerances, 3 consent withdrawals, and 2 for other reasons.
Safety: Frequent TRAEs (all grades; grade 3-4; SAEs) included thrombocytopenia (70.7%; 48.8%; 7.3%), anemia (70.7%; 31.7%; 2.4%), leukopenia (51.2%; 14.6%; 0), and neutropenia (41.4%; 21.9%; 0). Common nonhematologic TRAEs (all grades; grade 3-4) included skin pigmentation (56.1%; 0%) and elevations in creatine kinase (56.1%; 19.5%), alanine transaminase (ALT, 43.9%; 2.4%) and aspartate aminotransferase (AST, 36.6%; 0) levels.
As of the cutoff date of April 30,2022, 23 patients were enrolled, of whom 18 (78.3%) were male, with a median age of 41 (range, 21-74) years. The median interval from CML diagnosis to first olverembatinib dose was 4.96 (range, 0.4-10.2) years, and 19 (82.6%) patients had received ≥ 2 prior TKIs. The median treatment duration was 19.7 (range, 1.4-36.4) months.
Preliminary efficacy: A total of 18 (78.3%) patients experienced a major hematologic response (MaHR) (73.9% CHR and 4.4% no evidence of leukemia [NEL]); 12 (52.2%) MCyR; 12 (52.2%) CCyR; and 11 (47.8%) MMR. The median time to MaHR was 2.8 (95% CI: 1.0-4.7) months, the median time to MCyR was 5.6 (95% CI: 2.00-NR) months, and the median time to MMR was 13.1 (95% CI: 5.6-22.4) months. At 36 months, the PFS rate was 57.1% (95% CI: 33.3%-75.1%) and the OS rate was 69.6% (95% CI: 46.6%-84.2%). 6 patients withdrew because of PD, 4 because of intolerances, and 1 for other reasons; two patients died.
Safety: Common TRAEs (all grades; grade 3-4; SAEs) included thrombocytopenia (78.3%; 56.5%; 17.4%), anemia (69.6%; 34.8%; 13.0%), leukopenia (56.5%; 30.4%; 0), and neutropenia (26.1%; 26.1%; 0). Common nonhematologic AEs included skin pigmentation (69.6%), hypocalcemia (52.2%), proteinuria (56.5%), hypertriglyceridemia (60.9%), hyperphosphatemia (47.8%), hyperuricemia (26.1%), and arthralgia (34.8%), of which most were grade 1-2.
A Five-Year Follow-up on Safety and Efficacy of Olverembatinib (HQP1351), a Novel Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI), in Patients with TKI-Resistant Chronic Myeloid Leukemia (CML) in China
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK.
Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of nine clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 50 Phase I/II clinical trials in the US, Australia, Europe, and China. Olverembatinib, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), was granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and is already approved for the indication. In addition, olverembatinib was also granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EU. To date, Ascentage Pharma has obtained a total of 15 ODDs, 2 FTDs, and 2 Rare Pediatric Disease (RPD) designations from the FDA and 1 ODD from the EU for four of the company's investigational drug candidates. Ascentage Pharma has been designated for multiple Major National R&D Projects, including 5 National Major New Drug Discovery and Manufacturing projects, 1 New Drug Incubator status, 4 Innovative Drug Programs, and 1 Major Project for the Prevention and Treatment of Infectious Diseases.
Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, Merck, AstraZeneca, and Pfizer. The company has built a talented team with global experience in discovering, developing, launching, and commercializing innovative drugs and is setting up world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.
Forward-Looking Statements
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