- Xin Bei Li®(Asciminib Hydrochloride Tablets) is the world's first and currently the only targeted drug based on the innovative STAMP (Specific Targeting of ABL Myristoyl Pocket) mechanism.1`, bringing a completely new mechanism breakthrough for CML treatment.`
- This approval is based on the pivotal Phase III ASC4FIRST trial data.2，Confirm Letter Belief®Can enable patients to achieve double-depth relief, with discontinuations due to adverse events reduced by more than half.
- Despite TKIs having transformed the treatment of CML, unmet needs remain: up to 40% of newly diagnosed patients with CML-CP discontinue therapy within 5 years due to resistance or intolerance.9。
Today, Novartis Innovative Medicine Xinbei Li®(Asciminib Hydrochloride Tablets) have been approved by the National Medical Products Administration for the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP) in adult patients.As the world's first and currently only approved targeted drug based on the ABL myristoyl pocket (STAMP) innovative mechanism1, Asciminib can double the deep remission rate and halve the risk of discontinuation due to adverse events, delaying disease progression.2`, providing a new treatment option for patients with CML.`
Ian Lee, President and Managing Director of Novartis ChinaStated: "Novartis has long been deeply engaged in the field of hematological oncology, and for more than 20 years, it has successively brought several breakthrough innovative therapies for the treatment of CML, gradually transforming this once fatal disease into a controllable chronic condition. This time, Xibei Li...®"The approval in China marks another milestone for Novartis in the field of CML treatment, demonstrating Novartis' relentless pursuit of innovative research and development, as well as its unwavering commitment to improving the lives of patients with CML. In the future, we will continue to uphold the belief of 'Commitment to China,' bringing more innovative therapies to redefine disease treatment and help more patients achieve better health and a higher quality of life."
CML Enters the Era of Chronic Disease Management, Patient Quality of Life Still Faces Challenges
Chronic Myeloid Leukemia (CML), also known as chronic myelogenous leukemia or chronic granulocytic leukemia, is a malignant tumor formed by clonal proliferation of bone marrow hematopoietic stem cells, accounting for 15% of adult leukemia.3, one of the most common types of chronic leukemia4In China, there are approximately 9,300 new cases each year.5. In the era of conventional chemotherapy, the annual mortality rate of CML patients was 15%-20%, and the 10-year survival rate was less than 20%.6,7。
With the advent of tyrosine kinase inhibitors (TKIs) targeted drugs, the prognosis of patients has been greatly improved.CML has entered the era of being treatable and controllable as a chronic disease.7。However, TKI drug treatment can lead to adverse reactions due to off-target effects, with some patients experiencing fatigue, depression, and reduced work capacity due to intolerance, impacting their quality of life.A questionnaire survey result targeting CML patients in China shows that among patients hoping to stop TKIs treatment, approximately 41% are related to a decline in quality of life caused by TKIs-related adverse events.8In addition, up to 40% of newly diagnosed CML-CP patients switch treatments within five years due to resistance or intolerance.9。The increase in the number of treatment lines can lead to a poorer prognosis for patients, ultimately affecting their long-term survival.
Professor Wang Jianxiang, Clinical Chief Expert of the Leukemia Diagnosis and Treatment Center at the Chinese Academy of Medical Sciences and Director of the National Clinical Research Center for Hematological DiseasesStated: "Currently, the treatment goal for CML has shifted from 'extending survival' to improving quality of life and pursuing treatment-free remission (TFR). Although existing TKIs can significantly prolong survival, their long-term adverse effects still impact patients' quality of life. The median age of onset for CML patients in China is 45–50 years, and as the backbone of their families and society, their need to improve efficacy and pursue TFR is particularly urgent. Achieving this goal requires reaching a major molecular response (MMR) as early as possible, increasing the likelihood of achieving deep molecular response (DMR), while also considering the patient's long-term tolerance to medication, ensuring stable efficacy and quality of life. Asciminib has demonstrated superior efficacy, safety, and tolerability in trials, offering more options for clinical practice."
Asciminib Innovates STAMP Mechanism for More Efficient Treatment and Fewer Side Effects
Asciminib (asciminib, ABL001) is a novel allosteric inhibitor targeting the BCR-ABL1 kinase, utilizing a mechanism of action different from traditional TKIs. It binds to the myristoyl pocket (STAMP) of the target protein — an allosteric site that inhibits the target protein by altering its conformation. Due to this unique mechanism, asciminibDemonstrate higher selectivity, significantly reduce off-target effects, thereby minimizing adverse reactions and enhancing patient tolerance.10。
The approval of Asciminib was based on the pivotal Phase III ASC4FIRST trial data.Asciminib Demonstrates Excellent Performance in Efficacy, Safety, and Tolerability2。This study is the first Phase III trial to conduct a randomized head-to-head comparison with approved standard treatments, namely first-generation and second-generation TKIs.11. The results showed2In newly diagnosed patients, compared with the treatment regimens of first- or second-generation TKIs (imatinib, nilotinib, dasatinib, or bosutinib) chosen by investigators, the proportion of patients receiving asciminib who achieved MMR (i.e., BCR::ABL1 fusion gene level ≤ 0.1%) at week 96.Significantly improved compared to the control group(74.1% vs 52.0%, P<0.001). In terms of the rate of remission, the median time to achieve MMR for patients treated with Asciminib was only 24 weeks, which is 12-24 weeks shorter than the control group. Meanwhile, the achievement rate of DMR...Twice that of the control group，Fully validated the superior efficacy of Asciminib in achieving faster and deeper remission.
In this study2, asciminib also demonstrated good safety. Compared with first-generation and second-generation TKIs, the incidence of adverse events greater than Grade 3 with asciminib was lower, and the risk of treatment discontinuation due to adverse events was reduced by more than half. Thanks to better tolerability, during the 96-week observation period, nearly 80% of patients receiving asciminib continued to benefit from first-line treatment, while only 60% in the control group remained on first-line therapy.
The National Comprehensive Cancer Network (NCCN) has updated the "Clinical Practice Guidelines in Oncology" (NCCN Guidelines) for the treatment of CML.®), regardless of any risk stratification (Class 1 recommendation), Asciminib is recommended as the preferred option for newly diagnosed Ph+ CML-CP.12。
Compared with TKI drugs, Xibeli®(Asciminib Hydrochloride Tablets) have demonstrated excellent efficacy, safety, and tolerability due to their breakthrough mechanism.This approval in China marks that this innovative drug will not only provide more treatment options for CML patients, but also has the potential to change the overall landscape of CML treatment in China, ushering in a new era of STAMP precision targeted therapy.
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