 Home > Medical News > Latest Medical News > [2021 ASH] The clinical progress of Oribatinib, a new anti-drug-resistant leukemia drug, was selected as an oral report at the ASH annual meeting for the fourth time. A total of three studies of this product were selected

[2021 ASH] The clinical progress of Oribatinib, a new anti-drug-resistant leukemia drug, was selected as an oral report at the ASH annual meeting for the fourth time. A total of three studies of this product were selected

 Last Update: 2021-11-14
 Source: Internet
 Author: User

Tags

cut resistant leather gloves

pristine water treatment

Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

2021115 // -- 、——（6855.

1，BCR-ABL（Tyrosine Kinase Inhibitor，TKI），、TKI（CML），T315ICML

ASH、，、


(HQP1351)	Updated Safety and Efficacy Results of Phase 1 Study of Olverembatinib (HQP1351), a Novel Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI), in Patients with TKI-Resistant Chronic Myeloid Leukemia (CML) BCR-ABL（TKI）（HQP1351）TKI（CML）I	311
Updated Results of Pivotal Phase 2 Trials of Olverembatinib (HQP1351) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI)-Resistant BCR-ABL1T315I-Mutated Chronic- and Accelerated-Phase Chronic Myeloid Leukemia (CML-CP and CML-AP) Oribatinib (HQP1351) is the key to the treatment of tyrosine kinase inhibitor (TKI)-resistant BCR-ABL1 T315I mutant chronic myelogenous leukemia (CML-CP and CML-AP) subjects The latest results of the phase II trial	3598	Poster display
Trial in Progress: Phase 1b Bridging Study of the Pharmacokinetic (PK), Safety, and Efficacy of Orally Administered Olverembatinib (HQP1351) in Patients with Refractory Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph +ALL) Research progress: Thepharmacokinetics (PK), safety and effectiveness of oral aoribatinib (HQP1351) in the treatment of refractory chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) Phase 1b bridging study	2551	Poster display
Lisaftoclax (APG-2575)	A Phase 1 Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Lisaftoclax (APG-2575), a Novel BCL-2 Inhibitor (BCL-2i), in Patients (pts) with Certain Relapsed or Refractory (R /R) Hematologic Malignancies (HMs) Phase I clinical study of the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of the new BCL-2 inhibitor lisaftoclax (APG-2575) in the treatment of hematological tumors (HMs)	3730	Poster display
Trial in Progress: Phase 1b Study of Lisaftoclax (APG-2575) As a Single Agent or Combined with Other Therapeutic Agents in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (R/R CLL/SLL) Phase Ib clinical study of lisaftoclax (APG-2575) as a single agent or in combination in the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL)	1554	Poster display
Pelcitoclax (APG-1252)	Antitumor Activity of Dual BCL-2/BCL-xl Inhibitor Pelcitoclax (APG-1252) in Natural Killer/T-Cell Lymphoma (NK/TCL) Anti-natural killer/T cell lymphoma (NK/TCL) activity of BCL-2/BCL-xL dual target inhibitor pelcitoclax (APG-1252)	2062	Poster display

Dr.

The research summary of Orebatinib selected for the 2021 ASH Annual Meeting is as follows:

Updated Safety and Efficacy Results of Phase 1 Study of Olverembatinib (HQP1351), a Novel Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI), in Patients with TKI-Resistant Chronic Myeloid Leukemia (CML)

The new third-generation BCR-ABL tyrosine kinase inhibitor ( TKI ) oribatinib ( HQP1351 ) is the latest in the safety and effectiveness of the Phase I study of TKI- resistant chronic myelogenous leukemia ( CML ) subjects result

Presentation form: oral report
Abstract Number: 311
Session: 632.

-From October 26, 2016 to February 2, 2021 (data cut-off date), 101 CML-CP (n=86) and CML-AP (n=15) subjects were included in the study and received Ole Treatment of bartinib

-Among evaluable subjects who did not achieve remission at baseline, the hematological complete remission rate (CHR) was 97.

-Among CML-CP subjects, the CHR of the evaluable subjects with the T315I mutation was 100%, the significant cytogenetic response rate (MCyR) was 83.

-Among CML-AP subjects, CHR was 80.

At the 36th month, the progression-free survival (PFS) rates of subjects with CML-CP and CML-AP were 96.

The remission brought by oribatinib is long-lasting and is not affected by the baseline BCR-ABL1 mutation status

-Most of the treatment-related adverse events were grade 1 or 2

-The most common non-hematological adverse events (mostly grade 1 or 2) were skin pigmentation (86.

-The most common hematological adverse event related to treatment was a decrease in platelet count in 78 patients (77.

-Conclusion: Orebatinib has good efficacy and tolerability for TKI-resistant CML-CP or CML-AP and long-term treatment subjects

Updated Results of Pivotal Phase 2 Trials of Olverembatinib (HQP1351) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI)-Resistant BCR-ABL1 T315I -Mutated Chronic- and Accelerated-Phase Chronic Myeloid Leukemia (CML-CP and CML-AP)

Orebatinib ( HQP1351 ) is the key to the treatment of tyrosine kinase inhibitor ( TKI )-resistant BCR-ABL1 T315I mutant chronic myelogenous leukemia in chronic and accelerated phase ( CML-CP and CML-AP ) subjects of II the latest results of the trial
- Display form: poster display
- Abstract Number: 3598
- Session: 632.
  
  -As of August 25, 2020, a total of 41 CML-CP patients were enrolled in HQP1351-CC201, of which 32 (78%) completed >= 12 cycles, and the median follow-up time was 13 (3.
  1-16.
  3) months
  .
  Subjects who did not respond at baseline had a CHR of 100% after >= 12 treatment cycles
  .
  MCyR was 75.
  6% (31/41), CCyR was 68.
  3% (28/41), and MMR was 56.
  1% (23/41)
  .
  The PFS rate of the subjects at the 12th month was 89.
  3%, and the overall survival (OS) rate was 100%
  .
  
  -As of July 27, 2020, a total of 23 CML-AP patients were enrolled in HQP1351-CC202, of which 14 (61%) completed >= 12 cycles, and the median follow-up time was 13.
  5 (1.
  4-15.
  2) months
  .
  In subjects who did not respond at baseline, after >= 12 treatment cycles, the hematological depth response rate (MaHR) reached 73.
  9% (17/23), MCyR was 52.
  2% (12/23), and CCyR was 47.
  8%% ( 11/23), MMR is 39.
  1% (9/23)
  .
  The PFS rate of the subjects at the 12th month was 74.
  1%, and the OS rate was 91.
  3%
  .
  
  -The most common grade 3/4 treatment-related adverse reaction (TRAE) in HQP1351-CC201 was thrombocytopenia (48.
  8%), and no treatment-related deaths occurred
  .
  
  -The most common grade 3/4 TRAE in HQP1351-CC202 is thrombocytopenia (56.
  5%)
  .
  
  -Conclusion: Orebatinib monotherapy has good efficacy and tolerability in TKI-resistant CML-CP and CML-AP and BCR-ABL1 T315I mutation CML subjects
  .
  
  Trial in Progress: Phase 1b Bridging Study of the Pharmacokinetic (PK), Safety, and Efficacy of Orally Administered Olverembatinib (HQP1351) in Patients with Refractory Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph + ALL)
  
  Research progress : Pharmacokinetics ( PK ), safety and effectiveness of oral aoribatinib ( HQP1351 ) in the treatment of refractory chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) the 1b bridging study period
  - Display form: poster display
  - Abstract Number: 2551
  - Session: 632.
    Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster II (Chronic Myeloid Leukemia: Clinical and Epidemiological Progress: Poster Presentation II)
  - Time: Sunday, December 12, 2021, 6:00 PM – 8:00 PM, US Eastern Time / Monday, December 13, 2021, 7:00 AM – 9:00 AM, Beijing time
  - Core points:
  -This open bridging trial in the U.
  S.
  aims to evaluate the effects of oribatinib on chronic, accelerated, or blast CML (CML-CP, CML-AP, or CML- Pharmacokinetics (PK), safety and efficacy of adult subjects in BP) and Ph + ALL
  .
  Orebatinib is used orally and administered every other day
  .
  
  -Currently, this study is recruiting subjects, and eligible subjects will be randomly assigned to 3 dose groups: 30, 40 or 50 mg
  .
  The study endpoints include PK, anti-tumor activity and safety
  .
  
  About Yasheng Pharmaceutical
  
  Ascent Pharmaceuticals is an original innovative drug research and development company based in China and facing the world in the clinical development stage.
  It is committed to the development of innovative drugs in the treatment of tumors, hepatitis B and aging-related diseases
  .
  October 28, 2019, Asia-sheng medicine in the Hong Kong Stock Exchange Main Board listing, stock code: 6855.
  HK
  .
  
  Ascent Pharmaceuticals has a self-constructed protein-protein interaction targeted drug design platform, and is at the forefront of new drug development in the apoptosis pathway in the world
  .
  The company has established a pipeline of 8 new class 1 small molecule drug products that have entered the clinical development stage, including inhibitors that inhibit key proteins in the apoptosis pathway such as Bcl-2, IAP, or MDM2-p53; Inhibitors of kinase mutants, etc.
  , are the only innovative company in the world that has clinically developed varieties in the field of key proteins in the apoptosis pathway
  .
  The company is currently conducting more than 40 phase I/II clinical trials in China, the United States, Australia and Europe
  .
  The company has undertaken a number of major national science and technology projects, including 5 special projects for "Major New Drug Development", including 1 "Enterprise Innovative Drug Incubation Base" and 4 "Innovative Drug Research and Development", and another special project for "Prevention and Control of Major Infectious Diseases".
  
  .
  Oribatinib, the core product for the treatment of drug-resistant chronic myeloid leukemia, has submitted a new drug application for marketing in China and has been included in the priority review and breakthrough therapy product
  .
  This variety has also obtained the U.
  S.
  FDA's fast track review and orphan drug certification
  .
  Up to now, the company has 4 new drugs under development that have obtained 12 FDA orphan drug certifications
  .
  
  Relying on strong R&D capabilities, Yasheng Pharmaceuticals has deployed intellectual property rights globally, and cooperated with leading biotechnology and pharmaceutical companies such as UNITY, MD Anderson, Mayo Medical Center, Dana-Farber Cancer Institute, Merck & Co.
  , and AstraZeneca.
  Companies and academic institutions have reached a global partnership
  .
  The company has established an international talent team with rich experience in original innovative drug research and development and clinical development.
  At the same time, the company is building a late-stage commercial production and marketing team with high standards
  .
  Yasheng Pharmaceutical will continue to improve its research and development capabilities, accelerate the progress of the clinical development of the company's product pipeline, and truly implement the mission of "solving the unmet clinical needs of patients in China and even the world" to benefit more patients
  .
  
  Forward-looking statement
  
  The forward-looking statements made in this article only relate to events or information as of the date when the statement is made in this article
  .
  Except as required by law, we have no obligation to update or publicly revise any forward-looking statements and unexpected events after the date of forward-looking statements, regardless of whether new information, future events or other circumstances appear
  .
  Please read this article carefully and understand that our actual future results or performance may differ materially from expectations
  .
  All statements in this article are made on the date of publication of this article and may change due to future developments
  .

Suzhou, China and Rockville, Maryland, U.
S.
November 5, 2021/PRNewswire/ ---Asheng, a leading biomedical company dedicated to the development of innovative drugs in the treatment of tumors, hepatitis B, and aging-related diseases Pharmaceuticals (6855.
HK) announced today that the company’s original Class 1 new drug, Olverembatinib (HQP1351, formerly known as Niketinib and Oribatinib), has three clinical developments selected for the 63rd American Blood One of the annual meetings of the American Society of Hematology (ASH) received an oral report
.
Professor Huang Xiaojun and Professor Jiang Qian from the Department of Hematology, Peking University People's Hospital are the main investigators of the oral report.
Professor Jiang Qian will give this report during the conference
.
This is the fourth consecutive year that Orebatinib's clinical progress has been selected as an oral report at the ASH annual meeting, which fully demonstrates the recognition of its efficacy and safety by the international hematology community
.

Orebatinib is an original Class 1 new drug under research by Ascent Pharmaceuticals, and is a new third-generation BCR-ABL tyrosine kinase inhibitor (Tyrosine Kinase Inhibitor, TKI), used to treat resistance to first- and second-generation TKIs Chronic myelogenous leukemia (CML), especially for CML patients with T315I mutation, has a good effect
.
Currently, the New Drug Marketing Application (NDA) of Oribatinib submitted by Ascent Pharmaceuticals in China is in the review process for the treatment of chronic phase (CML-CP) and accelerated phase (CML-AP) of CML with T315I mutation.
) Patients and have been included in the priority review
.
In addition, Orebatinib has also been included in the breakthrough therapy category by the Center for New Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), and is intended to treat the first and second generation TKI-resistant and/or intolerant CML-CPs.
Patient
.

The annual ASH Annual Conference is one of the largest and most comprehensive international academic conferences in the field of hematology in the world, bringing together the latest and most cutting-edge research and development progress in this field
.
The 63rd ASH Annual Conference will be held in Atlanta, USA from December 11 to 14, 2021 in the form of offline and online
.
This year, Ascent Pharmaceuticals has six clinical studies of three new drugs under development (oribatinib, APG-2575, APG-1252) selected for the ASH annual meeting to display and report (details of related research on APG-2575 and APG-1252) For information, please refer to another press release issued at the same time)
.

product	Summary	serial number	form
Oribatinib (HQP1351)	Updated Safety and Efficacy Results of Phase 1 Study of Olverembatinib (HQP1351), a Novel Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI), in Patients with TKI-Resistant Chronic Myeloid Leukemia (CML) The new third-generation BCR-ABL tyrosine kinase inhibitor (TKI) oribatinib (HQP1351) is the latest in the safety and effectiveness of the Phase I study of TKI-resistant chronic myelogenous leukemia (CML) subjects result	311	Oral report
Updated Results of Pivotal Phase 2 Trials of Olverembatinib (HQP1351) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI)-Resistant BCR-ABL1 T315I -Mutated Chronic- and Accelerated-Phase Chronic Myeloid Leukemia (CML-CP and CML-AP) Oribatinib (HQP1351) is the key to the treatment of tyrosine kinase inhibitor (TKI)-resistant BCR-ABL1 T315I mutant chronic myelogenous leukemia (CML-CP and CML-AP) subjects The latest results of the phase II trial	3598	Poster display
Trial in Progress: Phase 1b Bridging Study of the Pharmacokinetic (PK), Safety, and Efficacy of Orally Administered Olverembatinib (HQP1351) in Patients with Refractory Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph + ALL) Research progress: The pharmacokinetics (PK), safety and effectiveness of oral aoribatinib (HQP1351) in the treatment of refractory chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) Phase 1b bridging study	2551	Poster display
Lisaftoclax (APG-2575)	A Phase 1 Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Lisaftoclax (APG-2575), a Novel BCL-2 Inhibitor (BCL-2i), in Patients (pts) with Certain Relapsed or Refractory (R /R) Hematologic Malignancies (HMs) Phase I clinical study of the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of the new BCL-2 inhibitor lisaftoclax (APG-2575) in the treatment of hematological tumors (HMs)	3730	Poster display
Trial in Progress: Phase 1b Study of Lisaftoclax (APG-2575) As a Single Agent or Combined with Other Therapeutic Agents in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (R/R CLL/SLL) Phase Ib clinical study of lisaftoclax (APG-2575) as a single agent or in combination in the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL)	1554	Poster display
Pelcitoclax (APG-1252)	Antitumor Activity of Dual BCL-2/BCL-xl Inhibitor Pelcitoclax (APG-1252) in Natural Killer/T-Cell Lymphoma (NK/TCL) Anti-natural killer/T cell lymphoma (NK/TCL) activity of BCL-2/BCL-xL dual target inhibitor pelcitoclax (APG-1252)	2062	Poster display

product	Summary	serial number	form
Oribatinib (HQP1351)	Updated Safety and Efficacy Results of Phase 1 Study of Olverembatinib (HQP1351), a Novel Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI), in Patients with TKI-Resistant Chronic Myeloid Leukemia (CML) The new third-generation BCR-ABL tyrosine kinase inhibitor (TKI) oribatinib (HQP1351) is the latest in the safety and effectiveness of the Phase I study of TKI-resistant chronic myelogenous leukemia (CML) subjects result	311	Oral report
Updated Results of Pivotal Phase 2 Trials of Olverembatinib (HQP1351) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI)-Resistant BCR-ABL1 T315I -Mutated Chronic- and Accelerated-Phase Chronic Myeloid Leukemia (CML-CP and CML-AP) Oribatinib (HQP1351) is the key to the treatment of tyrosine kinase inhibitor (TKI)-resistant BCR-ABL1 T315I mutant chronic myelogenous leukemia (CML-CP and CML-AP) subjects The latest results of the phase II trial	3598	Poster display
Trial in Progress: Phase 1b Bridging Study of the Pharmacokinetic (PK), Safety, and Efficacy of Orally Administered Olverembatinib (HQP1351) in Patients with Refractory Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph + ALL) Research progress: The pharmacokinetics (PK), safety and effectiveness of oral aoribatinib (HQP1351) in the treatment of refractory chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) Phase 1b bridging study	2551	Poster display
Lisaftoclax (APG-2575)	A Phase 1 Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Lisaftoclax (APG-2575), a Novel BCL-2 Inhibitor (BCL-2i), in Patients (pts) with Certain Relapsed or Refractory (R /R) Hematologic Malignancies (HMs) Phase I clinical study of the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of the new BCL-2 inhibitor lisaftoclax (APG-2575) in the treatment of hematological tumors (HMs)	3730	Poster display
Trial in Progress: Phase 1b Study of Lisaftoclax (APG-2575) As a Single Agent or Combined with Other Therapeutic Agents in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (R/R CLL/SLL) Phase Ib clinical study of lisaftoclax (APG-2575) as a single agent or in combination in the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL)	1554	Poster display
Pelcitoclax (APG-1252)	Antitumor Activity of Dual BCL-2/BCL-xl Inhibitor Pelcitoclax (APG-1252) in Natural Killer/T-Cell Lymphoma (NK/TCL) Anti-natural killer/T cell lymphoma (NK/TCL) activity of BCL-2/BCL-xL dual target inhibitor pelcitoclax (APG-1252)	2062	Poster display

product

Summary

serial number

form

Oribatinib

(HQP1351)

The new third-generation BCR-ABL tyrosine kinase inhibitor (TKI) oribatinib (HQP1351) is the latest in the safety and effectiveness of the Phase I study of TKI-resistant chronic myelogenous leukemia (CML) subjects result

311

Oral report

Updated Results of Pivotal Phase 2 Trials of Olverembatinib (HQP1351) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI)-Resistant BCR-ABL1 T315I -Mutated Chronic- and Accelerated-Phase Chronic Myeloid Leukemia (CML-CP and CML-AP)

Oribatinib (HQP1351) is the key to the treatment of tyrosine kinase inhibitor (TKI)-resistant BCR-ABL1 T315I mutant chronic myelogenous leukemia (CML-CP and CML-AP) subjects The latest results of the phase II trial

3598

Poster display

Trial in Progress: Phase 1b Bridging Study of the Pharmacokinetic (PK), Safety, and Efficacy of Orally Administered Olverembatinib (HQP1351) in Patients with Refractory Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph + ALL)

Research progress: The pharmacokinetics (PK), safety and effectiveness of oral aoribatinib (HQP1351) in the treatment of refractory chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL) Phase 1b bridging study

2551

Poster display

Lisaftoclax (APG-2575)

A Phase 1 Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Lisaftoclax (APG-2575), a Novel BCL-2 Inhibitor (BCL-2i), in Patients (pts) with Certain Relapsed or Refractory (R /R) Hematologic Malignancies (HMs)

Phase I clinical study of the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of the new BCL-2 inhibitor lisaftoclax (APG-2575) in the treatment of hematological tumors (HMs)

3730

Poster display

Trial in Progress: Phase 1b Study of Lisaftoclax (APG-2575) As a Single Agent or Combined with Other Therapeutic Agents in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (R/R CLL/SLL)

Phase Ib clinical study of lisaftoclax (APG-2575) as a single agent or in combination in the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL)

1554

Poster display

Pelcitoclax (APG-1252)

Antitumor Activity of Dual BCL-2/BCL-xl Inhibitor Pelcitoclax (APG-1252) in Natural Killer/T-Cell Lymphoma (NK/TCL)

Anti-natural killer/T cell lymphoma (NK/TCL) activity of BCL-2/BCL-xL dual target inhibitor pelcitoclax (APG-1252)

2062

Poster display

product

Summary

serial number

form

product

Products Products

Summary

Abstract abstract

serial number

Number Number

form

Formal form

Oribatinib

(HQP1351)

The new third-generation BCR-ABL tyrosine kinase inhibitor (TKI) oribatinib (HQP1351) is the latest in the safety and effectiveness of the Phase I study of TKI-resistant chronic myelogenous leukemia (CML) subjects result

311

Oral report

Oribatinib

(HQP1351)

Oribatinib

(HQP1351)

The new third-generation BCR-ABL tyrosine kinase inhibitor (TKI) oribatinib (HQP1351) is the latest in the safety and effectiveness of the Phase I study of TKI-resistant chronic myelogenous leukemia (CML) subjects result

311

Oral report

3598

Poster display

3598

Poster display

2551

Poster display

2551

Poster display

Lisaftoclax (APG-2575)

Phase I clinical study of the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of the new BCL-2 inhibitor lisaftoclax (APG-2575) in the treatment of hematological tumors (HMs)

3730

Poster display

Lisaftoclax (APG-2575)

Phase I clinical study of the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of the new BCL-2 inhibitor lisaftoclax (APG-2575) in the treatment of hematological tumors (HMs)

3730

Poster display

Phase Ib clinical study of lisaftoclax (APG-2575) as a single agent or in combination in the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL)

1554

Poster display

Phase Ib clinical study of lisaftoclax (APG-2575) as a single agent or in combination in the treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL)

1554

Poster display

Pelcitoclax (APG-1252)

Antitumor Activity of Dual BCL-2/BCL-xl Inhibitor Pelcitoclax (APG-1252) in Natural Killer/T-Cell Lymphoma (NK/TCL)

Anti-natural killer/T cell lymphoma (NK/TCL) activity of BCL-2/BCL-xL dual target inhibitor pelcitoclax (APG-1252)

2062

Poster display

Pelcitoclax (APG-1252)

Antitumor Activity of Dual BCL-2/BCL-xl Inhibitor Pelcitoclax (APG-1252) in Natural Killer/T-Cell Lymphoma (NK/TCL)

Anti-natural killer/T cell lymphoma (NK/TCL) activity of BCL-2/BCL-xL dual target inhibitor pelcitoclax (APG-1252)

Antitumor Activity of Dual BCL-2/BCL-xl Inhibitor Pelcitoclax (APG-1252) in Natural Killer/T-Cell Lymphoma (NK/TCL)

Anti-natural killer/T cell lymphoma (NK/TCL) activity of BCL-2/BCL-xL dual target inhibitor pelcitoclax (APG-1252)

2062

Poster display

Dr.
Yifan Zhai, Chief Medical Officer of Ascent Pharmaceuticals, said: "The clinical research data of Orebatinib that will be presented at the 2021 ASH Annual Meeting has shown good efficacy and tolerability, which is exciting
.
The research progress of the drug has been in progress for four consecutive years.
Being selected for the ASH oral report more fully demonstrated the international hematology community’s recognition of oribatinib as a potential CML therapeutic drug
.
As China's first and the world's second third-generation BCR-ABL inhibitor, oribatinib is resistant The drug CML patients provides a treatment program with definite efficacy and better safety
.
We are eagerly looking forward to the early approval of oribatinib for marketing, so as to benefit drug-resistant CML patients in China and the world
.
"

The research summary of Orebatinib selected for the 2021 ASH Annual Meeting is as follows:

Presentation form: oral report
Abstract Number: 311
Session: 632.
Chronic Myeloid Leukemia: Clinical and Epidemiological: Mechanisms of resistance and expanded therapies
Reporting time: December 11, 2021, Saturday, 5:00 PM, US Eastern Time / December 12, 2021, Sunday, 6:00 AM, Beijing Time
Core points:

Presentation form: oral report

Abstract Number: 311

Session: 632.
Chronic Myeloid Leukemia: Clinical and Epidemiological: Mechanisms of resistance and expanded therapies

Reporting time: December 11, 2021, Saturday, 5:00 PM, US Eastern Time / December 12, 2021, Sunday, 6:00 AM, Beijing Time

Core points:

-This open, multi-center phase I clinical trial in China evaluated the safety of oribatinib for adult CML subjects in the chronic phase (CML-CP) or accelerated phase (CML-AP) And effectiveness
.
Eligible subjects include CML-CP or CML-AP patients who are resistant or intolerant to first-generation or second-generation TKIs
.
Oribatinib is administered orally, every other day, 28 days as a cycle, and there are 11 dose groups ranging from 1 to 60 mg
.
This study reports data from subjects with long-term follow-up records
.

-From October 26, 2016 to February 2, 2021 (data cut-off date), 101 CML-CP (n=86) and CML-AP (n=15) subjects were included in the study and received Ole Treatment of bartinib
.
Seventy-one (70.
3%) subjects were male, and the median (range) age was 40 (20-64) years old
.
The median (range) time interval from the diagnosis of CML to the first administration of oribatinib was 6.
0 (0.
3-15.
2) years
.
84 (83.
2%) subjects had previously received >= 2 TKI-therapies, and 63 (62.
4%) subjects had T315I mutations
.
Eleven subjects (10.
9%) were detected with compound mutations at baseline, of which 7 (63.
6%) had BCR-ABL1 T315I mutations
.
A total of 20 subjects (19.
8%) had 2 (n=13) or >= 3 (n=7) mutations
.
The median follow-up time was 30.
8 (1.
2-51.
8) months
.
As of the data cut-off date, 81 of the 101 subjects (80.
2%) continued to receive treatment, 18 cases (17.
8%) had a treatment time of more than 3 years, and 5 cases (5%) had a treatment time of more than 4 years
.

>= T315I >=

-Among evaluable subjects who did not achieve remission at baseline, the hematological complete remission rate (CHR) was 97.
0%, the cytogenetic complete remission rate (CCyR) was 62.
1%, and the deep molecular biology remission rate (MMR) was 51.
0 %
.

-Among CML-CP subjects, the CHR of the evaluable subjects with the T315I mutation was 100%, the significant cytogenetic response rate (MCyR) was 83.
7%, and the MMR was 71.
2%;

-Among CML-AP subjects, CHR was 80.
0%, MCyR and MMR were both 54.
5%
.

At the 36th month, the progression-free survival (PFS) rates of subjects with CML-CP and CML-AP were 96.
3% (89.
1%-98.
8%) and 71.
4% (40.
6%-88.
2%), respectively
.

The remission brought by oribatinib is long-lasting and is not affected by the baseline BCR-ABL1 mutation status
.
For subjects treated for more than 4 years, the CHR was 100%, the CCyR was 80%, and the MMR was 60%
.
The average PFS rate is 100% at the 36th month, 100% at the 48th month, and has not yet reached (NR-NR) at the 60th month
.

-Most of the treatment-related adverse events were grade 1 or 2
.

-The most common non-hematological adverse events (mostly grade 1 or 2) were skin pigmentation (86.
1%); non-hematological adverse events of grade 3 or above included hypertriglyceridemia (10.
9%), fever (6.
9%) and proteinuria (5.
0%)
.

-The most common hematological adverse event related to treatment was a decrease in platelet count in 78 patients (77.
2%), including 52 (51.
5%) >= grade 3 adverse events; 21 (20.
8%) subjects The reduction in white blood cell count was Grade 3 or above, but not serious; 16 subjects (15.
8%) had anemia of Grade 3 or above
.

-Conclusion: Orebatinib has good efficacy and tolerability for TKI-resistant CML-CP or CML-AP and long-term treatment subjects
.

Updated Results of Pivotal Phase 2 Trials of Olverembatinib (HQP1351) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI)-Resistant BCR-ABL1T315I-Mutated Chronic- and Accelerated-Phase Chronic Myeloid Leukemia (CML-CP and CML-AP)

Updated Results of Pivotal Phase 2 Trials of Olverembatinib (HQP1351) in Patients (Pts) with Tyrosine Kinase Inhibitor (TKI)-Resistant BCR-ABL1T315I-Mutated Chronic- and Accelerated-Phase Chronic Myeloid Leukemia (CML-CP and CML-AP)BCR-ABL1T315IT315I

（HQP1351）（TKI）BCR-ABL1T315I（CML-CPCML-AP）II

（HQP1351）（TKI）BCR-ABL1T315IT315I（CML-CPCML-AP）II

：
：3598
：632.
Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster III （：：III）
：20211213，，6：00 PM – 8：00 PM / 20211214，，7：00 AM – 9：00 AM
：

：

：3598

：632.
Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster III （：：III）

：20211213，，6：00 PM – 8：00 PM / 20211214，，7：00 AM – 9：00 AM

：

- HQP1351-CC201HQP1351-CC202、、II，TKI（BCR-ABL1T315I）CML-CPCML-AP
。40 mg、、28
。

T315I

- 2020825，HQP1351-CC20141CML-CP，32（78%）>=12，13（3.
1-16.
3）
。>=12，CHR100%
。MCyR75.
6%（31/41），CCyR68.
3%（28/41），MMR56.
1%（23/41）
。12PFS89.
3%, （OS）100%
。

>=>=

- 2020727，HQP1351-CC20223CML-AP，14（61%）>=12，13.
5（1.
4-15.
2）
。>=12，（MaHR）73.
9%（17/23），MCyR52.
2%（12/23），CCyR47.
8%%（11/23），MMR39.
1%（9/23）
。12PFS74.
1%, OS91.
3%
。

>=>=

- HQP1351-CC2013/4（TRAE）（48.
8%)，
。

- HQP1351-CC2023/4TRAE（56.
5%）
。

- ：TKICML-CPCML-APBCR-ABL1T315ICML
。

T315I

:（HQP1351）(CML)(Ph+ ALL)（PK）、1b

:（HQP1351）(CML)(Ph+ ALL)+（PK）、1b

：
：2551
：632.
Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster II（：：II）
：20211212，，6：00 PM – 8：00 PM / 20211213，，7：00 AM – 9：00 AM
：

：

：2551

：632.
Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster II（：：II）

：20211212，，6：00 PM – 8：00 PM / 20211213，，7：00 AM – 9：00 AM

：

-This open bridging trial in the U.
S.
aims to evaluate the effects of oribatinib on chronic, accelerated, or blast CML (CML-CP, CML-AP, or CML- Pharmacokinetics (PK), safety and efficacy of adult subjects in BP) and Ph + ALL
.
Orebatinib is used orally and administered every other day
.

-Currently, this study is recruiting subjects, and eligible subjects will be randomly assigned to 3 dose groups: 30, 40 or 50 mg
.
The study endpoints include PK, anti-tumor activity and safety
.

About Yasheng Pharmaceutical

About Yasheng PharmaceuticalAbout Yasheng Pharmaceutical

Ascent Pharmaceuticals is an original innovative drug research and development company based in China and facing the world in the clinical development stage.
It is committed to the development of innovative drugs in the treatment of tumors, hepatitis B and aging-related diseases
.
October 28, 2019, Asia-sheng medicine in the Hong Kong Stock Exchange Main Board listing, stock code: 6855.
HK
.

Ascent Pharmaceuticals has a self-constructed protein-protein interaction targeted drug design platform, and is at the forefront of new drug development in the apoptosis pathway in the world
.
The company has established a pipeline of 8 new class 1 small molecule drug products that have entered the clinical development stage, including inhibitors that inhibit key proteins in the apoptosis pathway such as Bcl-2, IAP, or MDM2-p53; Inhibitors of kinase mutants, etc.
, are the only innovative company in the world that has clinically developed varieties in the field of key proteins in the apoptosis pathway
.
The company is currently conducting more than 40 phase I/II clinical trials in China, the United States, Australia and Europe
.
The company has undertaken a number of major national science and technology projects, including 5 special projects for "Major New Drug Development", including 1 "Enterprise Innovative Drug Incubation Base" and 4 "Innovative Drug Research and Development", and another special project for "Prevention and Control of Major Infectious Diseases".

.
Oribatinib, the core product for the treatment of drug-resistant chronic myeloid leukemia, has submitted a new drug application for marketing in China and has been included in the priority review and breakthrough therapy product
.
This variety has also obtained the U.
S.
FDA's fast track review and orphan drug certification
.
Up to now, the company has 4 new drugs under development that have obtained 12 FDA orphan drug certifications
.

Relying on strong R&D capabilities, Yasheng Pharmaceuticals has deployed intellectual property rights globally, and cooperated with leading biotechnology and pharmaceutical companies such as UNITY, MD Anderson, Mayo Medical Center, Dana-Farber Cancer Institute, Merck & Co.
, and AstraZeneca.
Companies and academic institutions have reached a global partnership
.
The company has established an international talent team with rich experience in original innovative drug research and development and clinical development.
At the same time, the company is building a late-stage commercial production and marketing team with high standards
.
Yasheng Pharmaceutical will continue to improve its research and development capabilities, accelerate the progress of the clinical development of the company's product pipeline, and truly implement the mission of "solving the unmet clinical needs of patients in China and even the world" to benefit more patients
.

Forward-looking statement

Forward-looking statement Forward-looking statement

The forward-looking statements made in this article only relate to events or information as of the date when the statement is made in this article
.
Except as required by law, we have no obligation to update or publicly revise any forward-looking statements and unexpected events after the date of forward-looking statements, regardless of whether new information, future events or other circumstances appear
.
Please read this article carefully and understand that our actual future results or performance may differ materially from expectations
.
All statements in this article are made on the date of publication of this article and may change due to future developments
.

Source: Yasheng Pharmaceutical

This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.