1. Olverembatinib shows 66.0% MRD negativity in Phase III study. 2. Favorable safety profile noted alongside treatment efficacy. 3. FDA and EMA approve Phase III POLARIS-1 study of Olverembatinib. 4. Potential licensing agreement with Takeda for global commercialization. 5. Ascentage's pipeline gets significant attention at ASH Annual Meeting.
FAQ
Why Bullish?
The promising results from Olverembatinib could enhance investor confidence and potential market growth, similar to past successes for successful oncology drugs. The attention received at a major conference corroborates its clinical potential and could lead to increased pharmaceutical partnerships, thereby positively influencing AAPG's valuation.
How important is it?
The detailed findings from the Phase III study and the drug's potential to reshape treatment paradigms represent significant advancements for AAPG, contributing to its market visibility and financial outlook.
Why Long Term?
The results from the ongoing studies and potential commercialization agreements indicate emerging opportunities, analogous to similar drug approvals in oncology that take time to translate into market revenues and profitability.
Ascentage Pharma Unveils Promising Data from POLARIS-1 Study at ASH 2025
Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company, showcased groundbreaking results from its Phase III POLARIS-1 study at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. The study examined the efficacy of Olverembatinib (HQP1351) in combination with low-intensity chemotherapy for patients newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
Key Findings from the POLARIS-1 Study
The results indicated remarkable response rates for patients receiving Olverembatinib, demonstrating a **best minimal residual disease (MRD) negativity rate of 66.0%** and an **MRD-negative complete response (CR) rate of 64.2%** after three induction cycles. These findings highlight Olverembatinib's therapeutic potential, particularly for high-risk IKZF1plus patients, who exhibited a **90% molecular response rate**.
- MRD Negativity Rate: 66.0%
- MRD-Negative CR Rate: 64.2%
- Molecular Response Rate for IKZF1plus Patients: 90%
Study Background and Methodology
Conducted as a global registrational Phase III trial, POLARIS-1 evaluates Olverembatinib's efficacy and safety in Ph+ ALL patients. The trial's design encompassed a primary endpoint focusing on MRD negativity, specifically measuring BCR-ABL/ABL1 levels by quantitative PCR. The positive data presented at ASH 2025 underscores Olverembatinib's role as a cornerstone therapy in treating newly diagnosed Ph+ ALL.
Insights from Medical Leaders
Professor Suning Chen, from the First Affiliated Hospital of Soochow University, remarked, “Olverembatinib is emerging as a cornerstone in investigational combination chemotherapy regimens for patients with Ph+ ALL. It achieved both deep responses and low toxicity, potentially transforming the treatment landscape for this indication.”
Yifan Zhai, M.D., Ph.D., Chief Medical Officer at Ascentage Pharma, added, “The POLARIS-1 study positions Olverembatinib as a promising treatment option for Ph+ ALL. Its favorable clinical outcomes signify a new paradigm in managing this challenging disease.”
Safety and Tolerability of Olverembatinib
The combination of Olverembatinib with low-intensity chemotherapy was reported to be well-tolerated. Adverse events categorized as grade ≥ 3 occurred, with the following incidences:
- Neutropenia: 63.6%
- Thrombocytopenia: 56.4%
- Leukopenia: 54.5%
- Anemia: 49.1%
- Pneumonia: 30.9%
- Hypokalemia: 20%
- Abnormal hepatic function: 16.4%
Future Directions for Olverembatinib
Ascentage Pharma continues to advance Olverembatinib's clinical development, which is cleared by the U.S. FDA and EMA for multiple indications, including Ph+ ALL and chronic myeloid leukemia (CML). Currently, Olverembatinib is being explored in three global registrational Phase III studies, demonstrating its growing relevance in the treatment landscape.
The successful results from POLARIS-1 reinforce Ascentage Pharma's commitment to addressing unmet medical needs and advancing therapeutic options for patients globally. With the industry's eyes on AAPG and its innovative pipeline, Olverembatinib stands as a forefront treatment in addressing Ph+ ALL.