Live from ASCO 2024 | Oral Report Released Latest Data of Olverembatinib in SDH-Deficient GIST, Including a CBR of 92.3%
The ASCO Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world's most influential and prominent scientific gathering of the clinical oncology community. Presenting clinical development progress at the ASCO Annual Meeting for the seventh consecutive year, Ascentage had four clinical studies of three of the company's proprietary drug candidates selected for presentations, including an oral report, at ASCO 2024.
The oral report features the latest data that further validated the promising efficacy and manageable safety of olverembatinib in SDH-deficient GIST. The Phase I study enrolled a total of 26 patients with SDH-deficient GIST. Among these patients, 6 achieved partial responses (PR), 18 achieved stable diseases (SD) that lasted longer than four treatment cycles, with a clinical benefit rate (CBR) of 92.3% (24/26) and a median progression-free survival (PFS) of 25.7 months.
Olverembatinib, an orally-available novel TKI developed by
While being clinically developed and adopted for the treatment of hematologic malignancies, olverembatinib is also being clinically evaluated in patients with GIST. To date, olverembatinib has been granted a Breakthrough Therapy Designation by the
"SDH-deficient GIST represents a treatment gap that urgently needs new treatment options," said Prof.
"Building on data released at the ASCO Annual Meeting in the past two years, results presented in the oral report this year continued to demonstrate promising clinical benefits and manageable safety of olverembatinib in SDH-deficient GIST," said Dr.
Highlights of these data presented at ASCO 2024 are as follows:
Updated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST)
Abstract#: 11502
Session Title: Sarcoma
Date and Time: June 3, 2024, Monday,
First Author: Haibo Qiu, MD, PhD,
Highlights:
Background: SDH-deficient GIST is a subset of wild-type GIST that constitutes approximately 10% of GISTs. In the National Comprehensive Cancer Network (NCCN) guidelines, there is no preferred regimen for SDH-deficient GIST, thus indicating an urgent unmet medical need. Olverembatinib, approved in
Introduction: The aim of this study was to evaluate the safety and efficacy (per RECIST v1.1) of olverembatinib in patients with SDH-deficient GIST and other solid tumors. Olverembatinib was administered orally once every other day (QOD) in 28-day cycles.
Patient enrollment and methods: As of
Efficacy Results: In the 26 patients with SDH-deficient GIST, the median (range) duration of treatment was 15.6 (1.8-42.3) months. 6 of these patients achieved partial responses (PR); and another 18 patients achieved stable diseases (SD) lasting > 4 cycles. The clinical benefit rate (CBR, complete response [CR] + PR + SD > 4 cycles) was 92.3% (24/26), the longest treatment duration was 40 months, and the median (range) PFS was 25.7 months (12.9-not reached [NR]).
Safety results: The adverse event profile was the same as previously reported (Qiu H, et al, J Clin Oncol 41:11540), with no newly emergent safety issues observed.
Conclusions: Olverembatinib was well tolerated. In patients with SDH-deficient GIST, olverembatinib demonstrated a CBR exceeding 90% and significantly prolonged the estimated median PFS, indicating the potential benefit of this treatment and providing a benchmark for future studies in this rare subtype of GIST.
*Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland.
Appendix: The four clinical studies of
Drug Candidates |
Abstract Title |
Abstract# |
Format |
Olverembatinib (HQP1351) |
Updated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) and paraganglioma. |
#11502 |
Oral Report |
Lisaftoclax ( APG-2575 ) |
Safety and efficacy of lisaftoclax, a novel BCL-2 inhibitor, in combination with azacitidine in patients with treatment-naïve or relapsed or refractory acute myeloid leukemia. |
#6541 |
Poster Presentation |
Updated efficacy and safety results of BCL-2 inhibitor lisaftoclax (APG-2575) alone or combined with ibrutinib or rituximab in patients (pts) with Waldenström macroglobulinemia (WM). |
#7078 |
Poster Presentation |
|
APG-2449 |
Updated study results of novel FAK/ALK/ROS1 inhibitor APG-2449 in patients (pts) with non-small-cell lung cancer (NSCLC) resistant to second-generation ALK inhibitors. |
#3124 |
Poster Presentation |
About
Olverembatinib, the company's core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product in
Leveraging its robust R&D capabilities,
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,
View original content to download multimedia:https://www.prnewswire.com/news-releases/live-from-asco-2024--oral-report-released-latest-data-of-olverembatinib-in-sdh-deficient-gist-including-a-cbr-of-92-3-302164178.html
SOURCE