BeiGene Showcases Innovative Hematology Portfolio for B-cell Malignancies at ASH 2024

SAN MATEO, Calif.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a leading global oncology company, has announced its upcoming presentations at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, scheduled for December 7-10, 2024. The presentations will feature new data on a variety of B-cell malignancies and assets, including BRUKINSA® (zanubrutinib), the company's Bruton’s tyrosine kinase (BTK) inhibitor. BeiGene’s research will be highlighted across 21 abstracts, including four oral presentations.

Over the past five years since its initial approval, BRUKINSA has established itself as a standard treatment for numerous B-cell malignancies. Dr. Mehrdad Mobasher, Chief Medical Officer of Hematology at BeiGene, emphasized the significant impact of BRUKINSA in eliciting deep and durable responses, particularly in chronic lymphocytic leukemia (CLL) and Waldenström’s macroglobulinemia (WM). He also pointed out that BRUKINSA is merely the beginning, as pipeline data for BTK degrader BGB-16673 and BCL2 inhibitor sonrotoclax illustrate BeiGene's ongoing dedication to advancing treatments for cancer patients.

The presentations at ASH will include long-term data demonstrating the sustained progression-free survival (PFS) and deepening durable responses achieved with BRUKINSA. Key findings include:

1. **Phase 3 SEQUOIA Study**: Five-year follow-up from Cohort 1 revealed that BRUKINSA continues to provide significant PFS benefits for treatment-naïve CLL/SLL patients, with no new safety concerns.
2. **Long-Term Extension (LTE) Study**: Results from patients with treatment-naïve and relapsed/refractory (R/R) CLL showed that BRUKINSA, either alone or combined with obinutuzumab, achieved high overall and complete response rates. These responses were maintained over a median follow-up of up to 6.5 years without new safety issues.
3. **Phase 3 ASPEN Study**: Patients with WM in an LTE study exhibited durable responses and favorable safety profiles over a median follow-up of 5.8 years with BRUKINSA monotherapy.
4. **Phase 2 Study**: Patients who had previously tolerated acalabrutinib but needed to switch to BRUKINSA experienced effective and safe treatments, with most avoiding recurrence of prior intolerance.

Moreover, BeiGene’s pipeline data show early safety and efficacy for their BTK degrader BGB-16673 and BCL2 inhibitor sonrotoclax. These include first-in-human Phase 1/2 CaDAnCe-101 studies indicating manageable safety and promising results for BGB-16673 in patients with R/R CLL/SLL, WM, and R/R indolent non-Hodgkin’s lymphoma. BGB-16673 is the first and most advanced asset from BeiGene’s chimeric degradation activation compound (CDAC) platform. Additionally, an oral presentation from the BGB-11417-101 Phase 1 study highlighted the efficacy and tolerability of sonrotoclax in combination with BRUKINSA for treatment-naïve CLL/SLL patients.

During the ASH conference, BeiGene will present several abstracts, including posters and oral presentations, on various topics such as patient preferences, real-world utilization, long-term outcomes, and the impact of novel therapies on clinical outcomes. These presentations will cover findings from the SEQUOIA study, the ASPEN study, and other ongoing trials.

BRUKINSA, an orally available BTK inhibitor, has been designed to offer complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. It holds the broadest label globally among BTK inhibitors and offers flexible dosing options. The BRUKINSA clinical development program spans around 6,000 patients across 30 countries with over 35 trials. BRUKINSA is now approved in over 70 markets, treating more than 100,000 patients worldwide.

BeiGene continues to solidify its position in the oncology field with a broad portfolio and a commitment to making innovative treatments accessible globally. The company’s efforts in research and development reflect its mission to improve the lives of cancer patients through advanced and affordable therapies.