1. Lisaftoclax shows 31.8% response rate in venetoclax-resistant patients. 2. 80% overall response rate in newly diagnosed high-risk MDS/CMML patients. 3. Strong safety profile reported with no dose-limiting toxicities in study. 4. Ascentage presents promising data at American Society of Hematology Annual Meeting. 5. Lisaftoclax aimed at addressing unmet medical needs in various cancers.
FAQ
Why Bullish?
The positive clinical trial results for Lisaftoclax indicate promising growth potential. Historical parallels can be drawn to successful launches of innovative cancer treatments that led to stock price increases. For example, if the results for Lisaftoclax lead to FDA approval, AAPG's stock could see a similar boost as observed with prior cancer drug approvals.
How important is it?
Lisaftoclax's clinical results enhance AAPG's potential for market approval and commercialization, which are critical for investor confidence and future earnings.
Why Long Term?
As Lisaftoclax progresses through clinical trials, it could significantly impact AAPG's long-term growth. Current results may set the stage for future approvals and market penetration, echoing cases like that of Gilead Sciences' Harvoni, whose sustained success over years resulted from initial favorable results.
Ascentage Pharma Presents Promising Data on Lisaftoclax at ASH 2025
Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) has unveiled preliminary clinical results from a Phase Ib/II study of Lisaftoclax (APG-2575) at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. The study highlights Lisaftoclax's potential to overcome resistance to venetoclax in patients with myeloid malignancies, showing a 31.8% overall response rate (ORR). Notably, a remarkable 80% ORR was achieved among newly diagnosed high-risk myelodysplastic syndromes/chronic myelomonocytic leukemia (MDS/CMML) patients.
Highlights from the Phase Ib/II Study
The recent data presented by Ascentage Pharma demonstrates the efficacy and safety profile of Lisaftoclax in combination with azacitidine (AZA). The study included a total of 103 patients, with mixed diagnoses encompassing newly diagnosed and relapsed or refractory cases of acute myeloid leukemia (AML) and MDS. Several key findings were reported:
- The overall response rate (ORR) for relapsed/refractory AML/MPAL was 43.2%
- In the group of venetoclax-exposed relapsed/refractory patients, the ORR was 31.8%
- Among newly diagnosed high-risk MDS/CMML patients, the ORR reached 80.0%, with 40.0% achieving complete response (CR).
- Median overall survival rates were measured at 7.6 months for R/R AML/MPAL and 11.3 months for R/R MDS/CMML patients.
Safety and Tolerability
As per the safety results, there were no dose-limiting toxicities noted during both the dose-escalation and dose-expansion phases. The most frequently observed grade ≥3 treatment-emergent adverse events were:
- Neutropenia: 41.7%
- Febrile Neutropenia: 35.0%
- Thrombocytopenia: 26.2%
- Anemia: 17.5%
These findings suggest that the combination of Lisaftoclax and AZA not only presents clinical efficacy but also has a robust safety profile across different patient cohorts.
Expert Insights from Ascentage Pharma
Yifan Zhai, M.D., Ph.D., Chief Medical Officer of Ascentage Pharma, expressed optimism regarding the findings. He stated, “It is our great pleasure to present continued progress in the clinical development of Lisaftoclax in myeloid malignancies... We hope that Lisaftoclax will bring a breakthrough to the clinical management of myeloid malignancies.”
About Lisaftoclax and Future Prospects
Ascentage Pharma is committed to addressing unmet medical needs in cancer treatment. Lisaftoclax, currently under investigation in several global Phase III studies, aims to provide effective therapies for conditions such as chronic lymphocytic leukemia (CLL), AML, and MDS. The drug is already approved in China for specific indications and is part of a growing portfolio that includes the third-generation BCR-ABL1 inhibitor Olverembatinib and other promising candidates.
Conclusion
The ongoing research and results presented by Ascentage Pharma at ASH 2025 reinforce the potential of Lisaftoclax (AAPG) as a novel treatment option for patients facing difficult-to-treat myeloid malignancies, particularly those resistant to venetoclax. As the biopharmaceutical industry continues to advance, developments like this reflect the commitment to improving patient outcomes through innovative therapies.