Drugs / APG-2449
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06687070 | Dec 2024 → May 2026 overdue | carcinoma | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT03917043 | May 2019 → Dec 2027 expected | esophageal cancer, malignant pleural mesothelioma, non-small cell lung carcinoma, ovarian cancer | Ascentage Pharma Group Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2025-04-28 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Presents Results from Five Preclinical Studies at 2025 American Association of Cancer Research (AACR) Annual Meeting, Highlighting Strong Synergistic Effects of Olverembatinib Combined with Lisaftoclax ascentage.com ↗
today announced that it has presented results from five preclinical studies during poster presentations at the 2025 American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Chicago, Illinois, USA. |
| 2024-10-07 | Ascentage Pharma Group Inc. | Regulatory Registrational Phase III Studies of APG-2449 Cleared by China CDE for the Treatment of Patients with NSCLC ascentage.com ↗
APG-2449, a FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI), has been cleared by the Center for Drug Evaluation (CDE) of China’s National Medical Product Administration (NMPA) to enter two registrational Phase III studies |
| 2024-06-01 | Ascentage Pharma Group Inc. | Results Live from ASCO 2024 | Ascentage Pharma Releases Updated Data of FAK/ALK/ROS1 Inhibitor APG-2449 in Patients with NSCLC ascentage.com ↗
APG-2449 demonstrated preliminary efficacy in patients with NSCLC whose disease was TKI naïve and resistant to second-generation ALK inhibitors, especially in brain metastases. |
| 2024-05-23 | Ascentage Pharma Group Inc. | Results ASCO 2024 | Ascentage Pharma Releases Latest Results from Multiple Clinical Studies of Its Lead Drug Candidates ascentage.com ↗
These abstracts report on the company’s three lead drug candidates, including olverembatinib (HQP1351), the first and only China-approved third-generation BCR-ABL inhibitor; lisaftoclax (APG-2575), a BCL-2 selective inhibitor; and APG-2449, a FAK/ALK/ROS1 inhibitor. |
| 2024-04-07 | Ascentage Pharma Group Inc. | Results AACR 2024 | Ascentage Pharma Presents Results from Three Studies at 2024 American Association of Cancer Research Annual Meeting ascentage.com ↗
We are pleased to present the preclinical research data of four assets in our pipeline at the AACR 2024. |
| 2023-06-06 | Ascentage Pharma Group Inc. | Results Live from ASCO 2023 | Ascentage Pharma Releases Updated Data Showing APG-2449’s Potential as a New Treatment for Drug-Resistant NSCLC ascentage.com ↗
Among the 28 patients with ALK+ NSCLC that was resistant to second-generation ALK inhibitors, 8 achieved PR (8/28; 28.6%) when treated with APG-2449 at the RP2D. |
| 2023-05-27 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Presents Updated Results from Multiple Clinical Studies at American Society of Clinical Oncology Annual Conference ascentage.com ↗
Among the 27 patients with ALK+ NSCLC that was resistant to second-generation ALK inhibitors, 7 achieved PR (7/27; 25.9%) when treated with APG-2449 at the RP2D. |
| 2022-06-07 | Ascentage Pharma Group Inc. | Results ASCO 2022 | Ascentage Pharma Releases for the First Time Results of its FAK/ALK/ROS1 inhibitor APG-2449 Demonstrating Safety and Efficacy in Patients with Advanced NSCLC ascentage.com ↗
today announced that it has released the results from its Phase I first-in-human (FIH) study of the company’s novel FAK inhibitor and third-generation ALK/ROS1 tyrosine kinase inhibitor (TKI) APG-2449 |
| 2022-05-27 | Ascentage Pharma Group Inc. | Results ASCO 2022 | Ascentage Pharma Presents Updated Results from Multiple Clinical Studies Demonstrating Rapid Progress in Global Clinical Development ascentage.com ↗
Preliminary efficacy was observed in patients whose disease was resistant to second-generation or TKI-naïve. |
| 2022-04-14 | Ascentage Pharma Group Inc. | Results AACR 2022 | Ascentage Presents Six Preclinical Studies ascentage.com ↗
At this year’s AACR Annual Meeting, we presented preclinical data that support potential combination approaches between our lead candidates with drugs of different targets and mechanism of actions. |
| 2022-03-09 | Ascentage Pharma Group Inc. | Results Ascentage to Present Six Preclinical Studies at AACR 2022 ascentage.com ↗
This study shows that in mesothelioma tumor models, the FAK inhibitor APG-2449 can suppress tumor growth via autophagy induction and has demonstrated antitumor activities, thus provide theoretical support to the design of future clinical studies. |
| 2021-04-12 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Releases Preclinical Data of Its Core Drug Candidates at AACR Annual Meeting 2021, with Results Signifying the Potential of Multiple Combination Therapies in Cancer ascentage.com ↗
Focal adhesion kinase (FAK) inhibitor APG-2449 sensitizes ovarian tumors to chemotherapy via CD44 downregulation |
| 2021-03-10 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present the Latest Results from Six Preclinical Studies at AACR Annual Meeting 2021 ascentage.com ↗
These studies deepened our understanding of our drug candidate’s mechanism of actions, provided supportive evidence to our strategy for combination options and potential disease indications, and have therefore further advanced our clinical development of these therapeutic candidates. |
All press releases naming this drug 13 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | APG-2449 | “APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST” NCT06687070 ↗ |
| Action | Inhibit | “which inhibits FAK, ALK, and ROS1 with nanomolar potencies.” NCT03917043 ↗ |
| Modality | Small molecule | — CHEMBL5095166 ↗ |
| Route | Oral | “Orally once a day(QD), every 28 days as a cycle.” NCT06687070 ↗ |
| Target | ALK | “which inhibits FAK, ALK, and ROS1 with nanomolar potencies.” NCT03917043 ↗ |
| Target | ROS1 | “which inhibits FAK, ALK, and ROS1 with nanomolar potencies.” NCT03917043 ↗ |