From December 9th to 11th, as one of the largest academic events in the world of hematology, the American Society of Hematology (ASH) Annual Conference was successfully held. During this conference, a total of 24 papers from Baekje were included, of which 3 were presented orally. With the release of multiple research results, BeiGene's core self-developed product, Baiyue Ze& Reg; The advantages of Zebutinib as the best BTK inhibitor of its kind have once again been recognized by the international academic community. At the same time, BeiGene's other two independently developed differentiated BCL-2 inhibitors, sonrotoclax and BTK CDAC BGB-16673, have also achieved excellent research data in clinical trials, further demonstrating BeiGene's leading position and strong potential in the treatment of blood tumors.
At this ASH conference, BeiGene announced three important data presentations for Zebutinib, including the 3-year follow-up results of three global "head to head" ALPINE studies. Data shows that in the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients, at a median follow-up of 39 months, Zebutinib showed a sustained progression free survival (PFS) advantage over Ibrutinib, with 3-year PFS rates of 64.9% and 54.8%, respectively (HR: 0.68; P=0.0011).
The extended follow-up of the ALPINE study released this time suggests that the 3-year OS rate of the Zebutinib group is higher than that of the control group. The 3-year OS rates of the Zebutinib and Ibrutinib groups were 82.5% and 79.6%, respectively. The Zebutinib group showed a potentially better OS trend, and the Zebutinib group had fewer deaths (HR: 0.75; p=0.098). In addition, compared to Ibrutinib, Zebutinib continues to demonstrate more favorable safety and tolerability.
Thanks to the advancement of treatment methods, the overall survival (OS) of CLL patients is usually longer, so PFS has become the "gold standard" in clinical trials, and OS itself is not the main endpoint. After a follow-up period of more than 3 years, ALPINE data once again proves that Zebutinib has better efficacy and superior safety characteristics compared to Ibrutinib. Based on positive data from two global phase 3 clinical trials, including the ALPINE study, the US FDA has fully approved Zebutinib for the treatment of adult patients with CLL/SLL.
Based on its outstanding and long-lasting safety and efficacy demonstrated in various indications such as head to head research, Zebutinib continues to deepen its global commercialization map and has been approved in over 65 international markets. It is also the most approved and widely deployed BTK inhibitor with the most indications. In the first three quarters of 2023, the total global sales of Zebutinib amounted to 877 million US dollars. According to third-party forecasts, Zebutinib is expected to become a new "1 billion US dollar molecule" this year.
At this year's ASH conference, BeiGene also showcased the clinical progress of its core products, including the BCL-2 inhibitor sonrotoclax and BTK CDAC BGB-16673, which further solidified the company's leading position in the field of hematology.
As a potential "best in class" BCL-2 inhibitor, sonrotocrax has a shorter half-life and no drug accumulation compared to the already marketed BCL-2 inhibitor, which is expected to bring better safety features. At present, Sonrotoclax has a wide clinical layout, with over 600 patients enrolled in clinical trials, and has achieved differentiated effectiveness and safety in various indications.
With its differentiated innovation pipeline, strong global development capabilities, and broad clinical layout, BeiGene has established a comprehensive and integrated global independent capability, accelerating the development of innovative drugs, expanding drug accessibility, and entering the next wave of innovative research and development. (Yan Yun)