Trending...
- BumblebeeSmart Introduces Rounded Busy Board Set for Preschoolers
- Cut Costs & Boost Profits with the First Major Upgrade in 30 YEARS Replacing Rotary Lasers and Historic Clear Tube Altimeter Bubbles
- Discover Elevated Living - Preview the Stunning New Townhome Collection
ROCKVILLE, Md. and SUZHOU, China, Nov. 21, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily for malignancies, announced today that findings from a phase Ib multicenter clinical trial (NCT04260022) of its third-generation BCR-ABL1 tyrosine kinase inhibitor (TKI) have been published in the November 2024 issue of JAMA Oncology, marking a milestone in global awareness concerning the agent.
JAMA Oncology is among the most influential and high-ranking oncology publications, with a 2023 impact factor of 28.4. It is read widely by the clinical-oncology community, with 6.4 million original downloads or views per annum. In 2023, the journal accepted only about 155 (7%) of 2,223 research-article submissions.
Olverembatinib may help to address critical unmet clinical needs related to TKI treatment resistance and intolerance, which can impose formidable humanistic and economic burdens especially in heavily pretreated patients with suboptimal outcomes. For instance, arterial occlusive events (AOEs) constitute one salient and potentially dose-limiting treatment challenge with certain second- and third-generation TKIs.
This study (NCT04260022) randomly allocated 80 patients with chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph⁺ ALL) to receive oral olverembatinib 30, 40, or 50 mg on alternate days. The study population was heavily pretreated: approximately 18% of patients had received two prior TKIs, 28% three, and 54% at least four. Forty-six patients (57.5%) had received ponatinib; 25 (31.3%), asciminib; and 11 (13.8%), both medications.1
Among all evaluable patients with chronic-phase CML (CP-CML), the complete cytogenetic response (CCyR) rate was approximately 61% and the major molecular response (MMR) rate, approximately 42%. Cytogenetic and molecular responses were similar irrespective of the presence of the T315I mutation, which confers resistance against imatinib and all second-generation TKIs.1
Importantly, approximately 58% of patients with prior ponatinib treatment failure achieved CCyR and about 37%, MMR. Corresponding values in patients with asciminib treatment resistance were 50% and 33%.1
Olverembatinib was also well tolerated, with leading (typically mild or moderate) treatment-emergent adverse events including elevated blood creatine phosphokinase and thrombocytopenia. There were no fatal treatment-related adverse events. Treatment-related AOEs were infrequent (3%) and mild or moderate (grade 1 or 2); no such olverembatinib-related event was considered serious.
"I am delighted to showcase the strength and progress of the 'lead' asset of Ascentage Pharma, which exemplifies the richness and diversity of our product pipeline of innovative, patient-centric therapies for a range of hematologic malignancies," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "In the future, we will continue to advance these development programs in efforts to bring more treatment options to patients with unmet clinical needs around the world."
More on The PennZone
"One potential explanation for the response of olverembatinib in patients with ponatinib and asciminib resistance is its broad (pan-BCR::ABL1-kinase domain) mutational coverage," said principal investigator Elias Jabbour, MD, Professor of Leukemia at The University of Texas MD Anderson Cancer Center. "In studies to date, olverembatinib has shown greater sensitivity and clinical benefit against compound mutations – two or more mutations within the same allele of BCR::ABL1 – compared with other approved TKIs and the STAMP inhibitor asciminib."
Findings from this trial have also been presented at leading hematologic-oncology congresses around the world, including the 29th European Hematology Association Congress, which convened June 13-16, 2024, in Madrid; the 12th annual meeting of the Society of Hematologic Oncology, on September 4-7, 2024, in Houston, Texas; and the ESH-iCMLf 26th Annual John Goldman Conference on Chronic Myeloid Leukemia (Biology and Therapy), on September 27-29, 2024, in Prague. Updated results will be presented at the 66th American Society of Hematology Annual Meeting and Exposition, December 8, 2024 (6:00-8:00 PM), in San Diego, CA (poster/publication #3151).
"Publication of our trial results in JAMA Oncology represents a major milestone for olverembatinib, and the study established the recommended dose for our ongoing phase III registrational trial: POLARIS-2 [NCT06423911]," said Dr. Dajun Yang, Chairman & CEO of Ascentage. "We look forward to that trial and, in the future through our option agreement with Takeda, to potentially bring this medication to underserved populations around the world, including patients with CML or Ph⁺ ALL that is resistant to or intolerant of other medications."
On June 14, 2024, Ascentage signed an exclusive option agreement to enter into an exclusive license agreement with Takeda (www.takeda.com) for olverembatinib. In the event that Takeda exercises the option, Takeda would license the global rights to develop and commercialize olverembatinib in all territories outside of, among others, mainland China, Hong Kong, Macau, and Taiwan, China.
Olverembatinib is currently approved in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase CP-CML or accelerated-phase CML harboring the T315I mutation as confirmed by a validated diagnostic test. It is also approved for adult patients with CP-CML resistant to and/or intolerant of first- and second-generation TKIs. It remains investigational in other parts of the world.
Reference
1. Jabbour E, Oehler VG, Koller PB, et al. Olverembatinib after failure of tyrosine kinase inhibitors, including ponatinib or asciminib: a phase 1b randomized clinical trial. JAMA Oncol 2024. doi:10.1001/jamaoncol.2024.5157
More on The PennZone
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a global, integrated biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily in malignancies. 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.
The company has built a rich pipeline of innovative drug candidates that includes 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 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 has conducted more than 40 clinical trials in the US, Australia, Europe, and China, including 13 registrational studies (completed/ ongoing/planned).
Olverembatinib, the company's first lead asset developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product in China, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted Orphan Drug Designations (ODDs) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU.
To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies such as Takeda, AstraZeneca, Merck, Pfizer and Innovent; and research and development relationships with leading research institutions such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan.
The company has built a talented team with a wealth of global experience in the discovery and development of innovative drugs and fully functional 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
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions and expectations or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions and expectations may alter in light of future development.
SOURCE Ascentage Pharma
WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?
440k+
Newsrooms &
Influencers
9k+
Digital Media
Outlets
270k+
Journalists
Opted In
GET STARTED
JAMA Oncology is among the most influential and high-ranking oncology publications, with a 2023 impact factor of 28.4. It is read widely by the clinical-oncology community, with 6.4 million original downloads or views per annum. In 2023, the journal accepted only about 155 (7%) of 2,223 research-article submissions.
Olverembatinib may help to address critical unmet clinical needs related to TKI treatment resistance and intolerance, which can impose formidable humanistic and economic burdens especially in heavily pretreated patients with suboptimal outcomes. For instance, arterial occlusive events (AOEs) constitute one salient and potentially dose-limiting treatment challenge with certain second- and third-generation TKIs.
This study (NCT04260022) randomly allocated 80 patients with chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph⁺ ALL) to receive oral olverembatinib 30, 40, or 50 mg on alternate days. The study population was heavily pretreated: approximately 18% of patients had received two prior TKIs, 28% three, and 54% at least four. Forty-six patients (57.5%) had received ponatinib; 25 (31.3%), asciminib; and 11 (13.8%), both medications.1
Among all evaluable patients with chronic-phase CML (CP-CML), the complete cytogenetic response (CCyR) rate was approximately 61% and the major molecular response (MMR) rate, approximately 42%. Cytogenetic and molecular responses were similar irrespective of the presence of the T315I mutation, which confers resistance against imatinib and all second-generation TKIs.1
Importantly, approximately 58% of patients with prior ponatinib treatment failure achieved CCyR and about 37%, MMR. Corresponding values in patients with asciminib treatment resistance were 50% and 33%.1
Olverembatinib was also well tolerated, with leading (typically mild or moderate) treatment-emergent adverse events including elevated blood creatine phosphokinase and thrombocytopenia. There were no fatal treatment-related adverse events. Treatment-related AOEs were infrequent (3%) and mild or moderate (grade 1 or 2); no such olverembatinib-related event was considered serious.
"I am delighted to showcase the strength and progress of the 'lead' asset of Ascentage Pharma, which exemplifies the richness and diversity of our product pipeline of innovative, patient-centric therapies for a range of hematologic malignancies," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "In the future, we will continue to advance these development programs in efforts to bring more treatment options to patients with unmet clinical needs around the world."
More on The PennZone
- Lokal Media House Achieves Yelp Platinum Partner Status
- World's First AI-Native Industrial Facility is Under Construction by Carbon AMS with rhobot.ai
- VIP Vacations Wins Diamon Status with AIC Hotel Group
- $57 Billion U.S. Marine Industry Presents Major Growth Opportunity for Newly Public Off The Hook Yacht Sales, Inc. (N Y S E: OTH)
- Deimler Chiropractic Announces Expansion
"One potential explanation for the response of olverembatinib in patients with ponatinib and asciminib resistance is its broad (pan-BCR::ABL1-kinase domain) mutational coverage," said principal investigator Elias Jabbour, MD, Professor of Leukemia at The University of Texas MD Anderson Cancer Center. "In studies to date, olverembatinib has shown greater sensitivity and clinical benefit against compound mutations – two or more mutations within the same allele of BCR::ABL1 – compared with other approved TKIs and the STAMP inhibitor asciminib."
Findings from this trial have also been presented at leading hematologic-oncology congresses around the world, including the 29th European Hematology Association Congress, which convened June 13-16, 2024, in Madrid; the 12th annual meeting of the Society of Hematologic Oncology, on September 4-7, 2024, in Houston, Texas; and the ESH-iCMLf 26th Annual John Goldman Conference on Chronic Myeloid Leukemia (Biology and Therapy), on September 27-29, 2024, in Prague. Updated results will be presented at the 66th American Society of Hematology Annual Meeting and Exposition, December 8, 2024 (6:00-8:00 PM), in San Diego, CA (poster/publication #3151).
"Publication of our trial results in JAMA Oncology represents a major milestone for olverembatinib, and the study established the recommended dose for our ongoing phase III registrational trial: POLARIS-2 [NCT06423911]," said Dr. Dajun Yang, Chairman & CEO of Ascentage. "We look forward to that trial and, in the future through our option agreement with Takeda, to potentially bring this medication to underserved populations around the world, including patients with CML or Ph⁺ ALL that is resistant to or intolerant of other medications."
On June 14, 2024, Ascentage signed an exclusive option agreement to enter into an exclusive license agreement with Takeda (www.takeda.com) for olverembatinib. In the event that Takeda exercises the option, Takeda would license the global rights to develop and commercialize olverembatinib in all territories outside of, among others, mainland China, Hong Kong, Macau, and Taiwan, China.
Olverembatinib is currently approved in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase CP-CML or accelerated-phase CML harboring the T315I mutation as confirmed by a validated diagnostic test. It is also approved for adult patients with CP-CML resistant to and/or intolerant of first- and second-generation TKIs. It remains investigational in other parts of the world.
Reference
1. Jabbour E, Oehler VG, Koller PB, et al. Olverembatinib after failure of tyrosine kinase inhibitors, including ponatinib or asciminib: a phase 1b randomized clinical trial. JAMA Oncol 2024. doi:10.1001/jamaoncol.2024.5157
More on The PennZone
- Dr. Alexander Eastman Returns to Suburban Hospital to Deliver Keynote on Crisis Leadership
- Scoop Social Co.'s Mobile Dessert Truck Business Offer A Lifestyle Of Flavor, Fun, and Freedom
- Own 327 Acres of American Prime Real Estate with 2 Miles Waterfront Worth In Millions for Just $7 — Worldwide Raffle Launched
- Lakefront Acreage in Longwood's Ravensbrook Community Hits the Market
- Monika Balayan Elected Fellow of the Royal Society of Arts (FRSA)
About Ascentage Pharma
Ascentage Pharma (6855.HK) is a global, integrated biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily in malignancies. 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.
The company has built a rich pipeline of innovative drug candidates that includes 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 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 has conducted more than 40 clinical trials in the US, Australia, Europe, and China, including 13 registrational studies (completed/ ongoing/planned).
Olverembatinib, the company's first lead asset developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product in China, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted Orphan Drug Designations (ODDs) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU.
To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies such as Takeda, AstraZeneca, Merck, Pfizer and Innovent; and research and development relationships with leading research institutions such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan.
The company has built a talented team with a wealth of global experience in the discovery and development of innovative drugs and fully functional 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
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions and expectations or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions and expectations may alter in light of future development.
SOURCE Ascentage Pharma
WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?
440k+
Newsrooms &
Influencers
9k+
Digital Media
Outlets
270k+
Journalists
Opted In
GET STARTED
Filed Under: Business
0 Comments
Latest on The PennZone
- Philadelphia City Council Issues Resolution to Honor Inner Strength Education's 10 Year Anniversary
- Guests Can Save 10 Percent Off New Vacation Rental Homes at KeysCaribbean's Village at Hawks Cay Villas
- Paylode Acquired by Moved to Power the Next Generation of Ancillary Revenue Automation
- Global Preschool Giants Unite to Celebrate the 12th Anniversary of Badanamu's Hit Song "Ponytail"
- America's Leading Annuity Expert Carlton Cap Averil II Joins Tom Hegna on "Financial Freedom with Tom Hegna"
- Cheeron Partners with CRCC to Support Shanghai East Railway Station
- MiBoxer Shines at 2025 Hong Kong International Lighting Fair, Intelligent Lighting Solutions Acclaimed by Global Clients
- Anern Launches the AN-SLZ2 Smart Integrated Solar Street Light
- "Nikko Kitchen," Tochigi Prefecture's New Gourmet Eatery, has Opened Near Tobu Nikko Station
- Michael Gi Delivers Inspiring New Gospel Releases That Lift Hearts and Honor Legacy
- Ashley Wineland To Release Scorching Single and Film Noir Cinematic Video for 'Love Letter'
- Chuckie F. Mahoney Memorial Foundation Funds Program to Curb Cyber Bullying in Burgettstown Schools
- Why Gourmet Steaks Are the Perfect Holiday Gift
- Together We Dance Foundation Thrives Through Donor and Athlete Support
- Platinum Plumbing Launches First Veteran Hot Water Heater Giveaway to Honor Local Heroes
- Cut Costs & Boost Profits with the First Major Upgrade in 30 YEARS Replacing Rotary Lasers and Historic Clear Tube Altimeter Bubbles
- Inframark Expands Its Specialized Automation and Intelligence Capabilities, Adds Dmytryka Jacobs Engineers
- Sustainable Santa Returns to Old Sacramento
- Upcoming Launch of Retail Crypto Cloud Mining Platform with Daily Rewards in a Transparent Revenue-Share Model: iMD Companies, Inc. Stock Symbol: ICBU
- BumblebeeSmart Introduces Rounded Busy Board Set for Preschoolers