Ascentage Pharma (NASDAQ: AAPG) presented four‑year follow‑up data from a randomized registrational Phase II trial of olverembatinib in tyrosine‑kinase‑inhibitor (TKI)‑resistant or intolerant chronic‑phase chronic myeloid leukemia (CML‑CP) at the 67th American Society of Hematology (ASH) Annual Meeting. The olverembatinib arm showed a median event‑free survival (EFS) of 21.2 months versus 2.9 months for investigator‑chosen best available therapy (BAT) (P = 0.0159). Response rates favored olverembatinib (complete hematologic response 85% vs 35%; complete cytogenetic response 38% vs 19%; major molecular response 30% vs 8%). Safety was described as favorable with a 7% incidence of vascular occlusion and grade ≥3 hematologic toxicities. Olverembatinib is approved in China and covered by the national reimbursement list; global rights are subject to a Takeda option.
Positive
- Median EFS extended by 18.3 months versus BAT (21.2 vs 2.9 months)
- EFS benefit observed in patients without the T315I mutation (11.9 vs 3.1 months)
- Complete hematologic response achieved in 85% of patients on olverembatinib
- 38% achieved complete cytogenetic response; 30% attained major molecular response
- Approved in China with NRDL coverage; commercialized with Innovent
- Three global Phase III registrational studies underway
Negative
- Vascular occlusion observed in 7% of treated patients
- Grade ≥3 hematologic toxicities reported
- Not yet approved by the FDA; U.S. regulatory pathway pending
- Global commercialization depends on Takeda exercising its option
Key Figures
Median EFS (all CML‑CP)
21.2 vs 2.9 months
Olverembatinib vs BAT, all CML‑CP patients
Median EFS (no T315I)
11.9 vs 3.1 months
Olverembatinib vs BAT, patients without T315I
Vascular occlusion rate
7%
Incidence in the olverembatinib arm over four‑year follow‑up
Study enrollment
144 patients
Total CML‑CP patients in Phase II trial (as of Jan 13 2025)
Patients without T315I
105 patients
CML‑CP subgroup lacking the T315I mutation
Complete hematologic response
85% vs 35%
Olverembatinib vs BAT
Complete cytogenetic response
38% vs 19%
Olverembatinib vs BAT
Major molecular response
30% vs 8%
Olverembatinib vs BAT
Market Reality Check
$31.31
Last Close
Volume
Volume 3,055 vs 20‑day average 4,633 (relative volume 0.66) suggests no heavy positioning ahead of the news.
low
Technical
Price $31.31 is trading below the 200‑day moving average of $31.79, indicating a subdued longer‑term trend.
Peers on Argus
AAPG fell 4.77% while peer moves were modest: MIRM –1.22%, ZLAB –0.94%, ACAD –3.29%, ACLX –1.16% and ARWR +2.25%. The mixed reaction points to a stock‑specific response rather than a sector‑wide swing.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 04 | Phase III clearance (POLARIS‑1) | Positive | +1.1% | Regulators cleared global Phase III POLARIS‑1 trial of olverembatinib in Ph⁺ ALL. |
| Nov 24 | Phase Ib data (SDH‑deficient GIST) | Positive | +1.1% | Publication of durable progression‑free survival signals in SDH‑deficient gastrointestinal stromal tumors. |
| Nov 19 | Investor conferences | Neutral | +0.6% | Company presented pipeline updates at multiple December investor meetings. |
| Nov 03 | ASH lisaftoclax data (CLL/SLL) | Positive | -3.1% | Registrational Phase II lisaftoclax data in CLL/SLL presented at ASH. |
| Nov 03 | ASH olverembatinib preview | Positive | -3.1% | Four‑year CML‑CP follow‑up data previewed at ASH 2025. |
Data‑heavy clinical updates have historically been followed by modest positive price moves, whereas large ASH preview packages have sometimes triggered short‑term declines despite favorable data.
Over the past six months Ascentage Pharma has highlighted progress across its pipeline. Olverembatinib gained global Phase III POLARIS‑1 clearance on Dec 4 2025 and earlier ASH 2023 abstracts showed strong MRD‑negative responses. Lisaftoclax entered multiple global Phase III programs, including a registration trial in CLL/SLL. Alrizomadlin reported encouraging Phase II data in rare solid tumors. The current four‑year CML‑CP follow‑up reinforces the drug’s long‑term efficacy and safety profile.
Market Pulse Summary
The four‑year follow‑up from the registrational Phase II CML‑CP study shows a median EFS of 21.2 months versus 2.9 months on BAT and a 7% vascular‑occlusion rate. These results extend earlier ASH 2023 findings and dovetail with ongoing global Phase III programs. Investors should monitor safety updates and the read‑out of the three Phase III registrational trials to gauge implications for regulatory approval and commercial rollout.
Key Terms
event‑free survival
medical
Event‑free survival measures the time from treatment initiation until a predefined negative outcome (disease progression, loss of response, death or unacceptable toxicity). For investors, a longer EFS signals durable efficacy, which can translate into stronger market adoption and pricing power.
tyrosine kinase inhibitor
medical
TKIs block signaling pathways that drive malignant cell growth. In CML, resistance or intolerance to first‑ and second‑generation TKIs creates an unmet need that third‑generation agents like olverembatinib aim to fill. Patent protection, companion diagnostics, and the ability to overcome resistance mutations are key commercial levers.
BCR‑ABL1
medical
BCR‑ABL1 is the fusion gene that drives CML. Targeting this abnormal kinase is the cornerstone of therapy, and the emergence of the T315I mutation renders many earlier TKIs ineffective, creating a niche for agents that can inhibit both wild‑type and mutant forms.
major molecular response
medical
Major molecular response (MMR) corresponds to a 3‑log reduction in BCR‑ABL1 transcript levels and is a recognized surrogate endpoint for long‑term survival. Higher MMR rates are associated with improved progression‑free outcomes and are used by regulators and payers to assess a drug’s value.
complete cytogenetic response
medical
CCyR means no detectable Philadelphia chromosome‑positive metaphases in the bone marrow. It is a robust indicator of disease control and is often a prerequisite for treatment‑free remission strategies.
Phase II study
medical
A Phase II trial evaluates efficacy and further monitors safety in a larger patient cohort after initial Phase I dose‑finding. Positive Phase II data reduce development risk, enable expedited regulatory pathways, and attract partnership interest.
AI‑generated analysis. Not financial advice.
FAQ
What were the median event‑free survival results for olverembatinib at ASH 2025?
The olverembatinib arm showed median EFS of 21.2 months versus 2.9 months for BAT (P = 0.0159).
How did olverembatinib perform in patients without the T315I mutation?
Median EFS was 11.9 months versus 3.1 months for BAT (P = 0.0159).
What safety signals were reported?
A 7% incidence of vascular occlusion and grade ≥3 hematologic toxicities were observed; no new safety signals emerged.
Is olverembatinib approved outside China?
It is approved in China and listed on the national reimbursement drug list. Global rights are tied to a Takeda licensing option.
What are the near‑term clinical programs investors should watch?
Three global Phase III registrational studies are ongoing in CML‑CP, newly diagnosed Ph⁺ ALL, and SDH‑deficient GIST.
AAPG Stock Data
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Biotechnology
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