The blockbuster results of Zebratinib ALPINE research were published in the Journal of Clinical Oncology

Recently, BeiGene's self-developed Bruton's tyrosine kinase (BTK) inhibitor BRUKINSA ^® (zebrutinib) global phase 3 head-to-head clinical trial ALPINE study interim analysis results were published in the Journal of Clinical oncology (JCO), the international top journal, with an impact factor of 50.
717 points
。 This award is another important recognition
of academic leadership following the high score of another global phase 3 head-to-head clinical trial SEQUOIA study of zebratinib published in The Lancet Oncology, another global phase 3 head-to-head clinical trial, in August this year.

ALPINE is a global Phase 3 clinical trial to evaluate the efficacy
of zebratinib versus ibrutinib for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
The successful publication in JCO is based on the results of its interim analysis, which shows that zebratinib achieves a better objective response rate (ORR)
than ibrutinib.
ONLY LAST MONTH, BEIGS ANNOUNCED THE RESULTS OF THE BLOCKBUSTER ALPINE END-OF-LIFE ANALYSIS, WHICH DEMONSTRATED THE PROGRESSION-FREE SURVIVAL (PFS) EFFICACY OF ZEBRATINIB HEAD-TO-HEAD OVER IBRUTINIB, SUPPORTING ZEBRATINIB AS THE ONLY NEXT-GENERATION BT INHIBITOR
IN THE CLL/SLL FIELD TO CONFIRM THE PFS EFFICACY OF IBRUTINIB.

Zebratinib's blockbuster research results have been continuously recognized by a series of top international journals and institutions, which not only fully demonstrates the international academic strength of zebratinib, but also confirms the breakthrough value of zebratinib in the field of disease treatment, and is expected to bring more academic recognition and benefit patients
around the world with excellent product strength.

The strongest evidence-based medical evidence, won multiple international top recognition

JCO is the official journal of the American Society of Clinical Oncology and one of the most influential oncology journals in the world, which has a significant impact
on oncology clinical practice and research.
Papers published in the journal often undergo multiple and rigorous peer reviews
.
The interim analysis results of the ALPINE study were published in JCO, demonstrating the full recognition
of the design, quality control and clinical value of the study by the international academic community.

Professor Qiu Lugui, the principal investigator of the ALPINE study in China and the Hospital of Hematology, Chinese Academy of Medical Sciences, said: "The results of ALPINE study show that zebratinib has shown significant benefits in efficacy and safety compared with ibrutinib, and has become the preferred treatment choice
in the field of chronic lymphocytic leukemia.
Recently, the interim analysis results of the study were published in JCO after peer review, which not only represents the recognition of this research by the international academic community, but also shows the importance of this research and the breakthrough value
it brings to the clinical and therapeutic fields.
"

Professor Constantine Tam, the main contributor to the APLINE study, an internationally renowned expert in chronic leukemia and indolent lymphoma, and Professor of Hematology at Monash University, said: "I am honored to participate in several zebratinib key studies such as the AU-003 study, SEQUOIA research and ALPINE study, and I am very pleased to see that the ALPINE study was published in JCO with high scores and selected as ASH's latest breakthrough abstract
。 This study further expands the clinical evidence of zebratinib, confirming that zebratinib, as a differentiated and highly selective novel BTK inhibitor, has the therapeutic potential of 'best in class, and enhances its international academic impact
with internationally prospective high-level global multi-clinical evidence-based medical data.
"

Redefining the next generation of BTK inhibitors with patients first

Patients with CLL/SLL require long-term treatment, and safety and tolerability of the drug in this patient population are critical
.
As the first BTK inhibitor approved for marketing, ibrutinib ushered in the era
of targeted therapy for CLL/SLL therapy.
However, as a generation of BTK inhibitors that have been on the market for nearly 9 years, ibrutinib has been shown to have certain deficiencies and safety risks
.

Since the beginning of this year, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have successively issued warnings to remind the cardiovascular risks
associated with the use of ibrutinib, the first-generation BTK inhibitor 。 Considering the toxicity of a generation of BTK inhibitors, the 2023 V1 version of the National Comprehensive Cancer Network (NCCN) CLL/SLL guidelines based on the latest international evidence-based medical evidence also shifted the recommendation of ibrutinib in first- and second-line CLL treatment from "priority recommendation" to "other recommendation", and zebratinib was upgraded to first-line del(17p)/TP53 mutation "class I.
priority recommendation"
.

By optimizing bioavailability, half-life and selectivity, as well as differentiated pharmacokinetic profiles with other approved BTK inhibitors, zebratinib achieves targeted, sustained inhibition of BTK protein, and is currently the only BTK inhibitor that achieves 24-hour sustained inhibition of targets at clinical doses, thus demonstrating stronger efficacy and more reliable safety
。 Professor Xu Wei of the Department of Hematology, the First Affiliated Hospital of Nanjing Medical University, said that "a really good BTK inhibitor should be both offensive and defensive, which can achieve continuous inhibition of BTK protein, and have lower off-target effect and more safety
。 From this point of view, zebratinib redefines 'a new generation of BTK inhibitors, the end-of-phase analysis of the ALPINE study' showed that zebratinib was more effective than ibrutinib, achieving significantly better PFS benefits (24-month PFS rate 80% vs 67%, p=0.
0024), significantly prolonging the survival of CLL/SLL patients, and potentially bringing more stable and long-term treatment benefits
to CLL patients.
"

Science-based to accelerate the reach of patients worldwide

Zebrutinib's series of major international academic recognitions not only demonstrate its breakthrough value in disease treatment, but also serve as a vivid example and exemplary achievement
of BeiGene's science-based spirit and forward-looking internationalization strategy.
Through "high-standard, large-scale, global" head-to-head trials, zebratinib's ALPINE trial is changing the competitive landscape
of innovative drugs.

"Head-to-head trials" are non-placebo-controlled trials, which are clinical trials that use therapeutic drugs or treatments that have been used clinically as controls, and can be regarded as a direct comparison
of the efficacy and safety of two drugs.
Thanks to its first-mover advantage as the world's first approved BTK inhibitor, ibrutinib has maintained an absolute market share for a long time while monopolizing the market
.
Currently, zebratinib is the only BTK inhibitor
in the world to conduct a head-to-head clinical trial with ibrutinib to evaluate efficacy and safety in the treatment of two hematologic malignancies CLL/SLL and Waldenstrom macroglobulinemia (WM).

"Conducting head-to-head research requires tremendous courage and commitment; Of course, it requires excellent product strength
.
In line with the original intention of 'Innovative Medicines, BeiGene's commitment to developing and commercializing innovative anti-tumor drugs
for patients around the world.
We want to bring truly high-quality innovative medicines that improve outcomes across the board for more patients around the world
.
"

As an innovative pharmaceutical company, BeiGene has launched a global layout in the early stage of zebratinib R&D and established long-term good cooperation with domestic and foreign experts, ensuring the wide and public nature of enrollment centers in drug development and clinical trials
.
Through global multicenter clinical trials, BeiGene has conducted 35 trials in more than 30 countries and territories around the world, enrolling more than 4,700 subjects, laying a solid global evidence-based foundation
for zebratinib.
To date, zebratinib has been approved
in more than 60 markets, including the United States, China, the European Union, the United Kingdom, Canada, Australia, South Korea and Switzerland.