BeiGene Highlights Progress in Hematology at EHA2021 Virtual Congress

Rhea-AI Summary

BeiGene, Ltd. (NASDAQ: BGNE) announced that key clinical results from its hematology program will be showcased at the EHA2021 Virtual Congress from June 9-17, 2021. The data includes promising results from the ALPINE and ASPEN trials, highlighting BRUKINSA's efficacy and tolerability across multiple B-cell malignancies. Additionally, long-term efficacy data for tislelizumab in classical Hodgkin’s lymphoma will be presented. New preliminary data for the BCL-2 inhibitor BGB-11417 is also anticipated. These updates aim to enhance patient outcomes and address unmet medical needs.

Positive

• BRUKINSA demonstrated superiority in objective response rate (ORR) per interim analysis in the ALPINE trial and showed lower risk of atrial fibrillation compared to ibrutinib.
• Long-term follow-up data from BRUKINSA trials indicated durable responses across various patient subgroups.
• Tislelizumab's long-term follow-up results highlight a 76.9% ORR in a pivotal Phase 2 trial, enhancing its clinical profile.
• Preliminary safety data from BGB-11417 suggest promising results for treating R/R B-cell malignancies.

Negative

• Progression-free survival (PFS) data in the ALPINE trial were immature at the data cutoff, which may raise concerns about long-term efficacy.
• Ongoing clinical trials may face risks related to regulatory approvals and market entry, affecting potential revenue streams.

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that clinical results from its broad hematology program will be presented at the 26^th European Hematology Association 2021 (EHA2021) Virtual Congress being held June 9 – 17, 2021.

“Following key head-to-head data from the positive ALPINE trial interim analysis and the previously announced ASPEN trial, we are thrilled to share additional updates from BRUKINSA’s broad global clinical program at EHA. In these trials, sustained responses with BRUKINSA treatment were observed consistently across multiple indications and patient subgroups, and it was well tolerated in patients, including those with previously treated B-cell malignancies who discontinued other BTK inhibitors due to intolerable adverse events,” said Jane Huang, M.D., Chief Medical Officer, Hematology of BeiGene. “In addition to BRUKINSA, we are pleased to be presenting long-term efficacy results from our anti-PD-1 antibody tislelizumab in classical Hodgkin’s lymphoma, which is approved for use in China. We are also encouraged by the preliminary safety data of our novel investigational Bcl-2 inhibitor and look forward to further evaluating this recently advanced clinical candidate in combination with BRUKINSA for patients with hematologic malignancies.”

To learn more about BeiGene’s research and development and activities around the EHA2021 Virtual Congress, please visit https://beigenemedical.eu.

Promising Head-to-Head and Long-Term Data Support BeiGene’s Aspiration to Improve Patient Outcomes for More Patients with BRUKINSA

Since its first-in-human study in 2014, a broad clinical program for BRUKINSA has provided a growing body of clinical evidence demonstrating its consistent efficacy and tolerability profile across B-cell malignancies, genotypes, and other patient characteristics. To further demonstrate the clinical profile of this molecule that was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity, BeiGene took a bold approach in the development of BRUKINSA, including two large-scale Phase 3 head-to-head trials against the first-generation BTK inhibitor ibrutinib:

• ALPINE trial in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) – in the recently announced positive interim results, BRUKINSA demonstrated superiority in objective response rate (ORR) per investigator assessment and non-inferiority in ORR per both investigator assessment and independent review committee (IRC). Data pertaining to progression-free survival (PFS), a secondary endpoint of the trial, were immature at the data cutoff for the interim analysis; however, the descriptive summaries of PFS showed an early trend favoring BRUKINSA. In addition, BRUKINSA demonstrated a statistically significant lower risk of atrial fibrillation or flutter compared to ibrutinib, and the overall safety profile of BRUKINSA was consistent with the previously seen profile in its clinical development program; and
• ASPEN trial in Waldenström’s macroglobulinemia (WM) – in the results presented at last year’s ASCO and EHA meetings, BRUKINSA demonstrated clinically meaningful improvements in safety and tolerability, including a lower risk of atrial fibrillation or flutter, and a favorable combined complete and very good partial response rate compared to ibrutinib.

In addition to the head-to-head trials demonstrating BRUKINSA’s clinical profile compared to ibrutinib, BRUKINSA is being evaluated in an ongoing Phase 2 trial in patients with previously treated B-cell malignancies who were intolerant to ibrutinib and/or acalabrutinib. Results from this trial at a prior data cutoff were presented in a poster at the 62nd ASH Annual Meeting in December 2020, including that most intolerable adverse events patients experienced on other BTK inhibitors did not recur with BRUKINSA treatment, and that the vast majority of patients who were evaluable for response at the time of data cutoff maintained or improved their responses on BRUKINSA. Updated results from this trial will be presented at EHA2021.

In June 2020, BRUKINSA received its first approvals in China in both R/R CLL and R/R mantle cell lymphoma (MCL). Long-term follow-up data from the clinical trials supporting these two approvals will be presented at EHA2021. From results in the accepted abstracts, BRUKINSA demonstrated deep and durable responses across all subgroups in these trials, including high-risk patients, with a median follow-up over 33 months. No new safety signals were identified.

BeiGene will also share updates from the pivotal Phase 2 MAGNOLIA trial of zanubrutinib in patients with R/R marginal zone lymphoma at EHA2021. Results from the MAGNOLIA trial were previously reported at ASH 2020.

BeiGene to Present Long-Term Follow-up Data of Tislelizumab in Classical Hodgkin’s Lymphoma (cHL)

Immune checkpoint inhibitors have catalyzed a paradigm shift in cancer treatment since the initial clinical evaluation approximately 15 years ago. Based on preclinical evidence that binding to Fc gamma receptors (FcγR) on macrophages can compromise antitumor activity, tislelizumab was uniquely engineered with minimal FcγR-binding to abrogate a potential T-cell clearance and resistance mechanism and therefore potentially improve efficacy for patients.

In late 2019, tislelizumab received its first approval in China for patients with cHL who have received at least two prior therapies, based on clinical results from a pivotal Phase 2 trial conducted in China (NCT03209973). At the time of approval, with a median follow-up time of 14 months, the ORR as assessed by IRC was 76.9% (95% CI: 64.8, 86.5), including 61.5% of patients who achieved a CR, and the median PFS was not estimable (NE; 95% CI: 13.1, NE). Grade 3 and above adverse reactions occurring in ≥2% of patients included pneumonitis, weight increase, severe skin reactions and hypertension. At EHA2021, long-term follow-up results from this trial will be available in an oral presentation.

BeiGene’s Growing Hematology Clinical Portfolio Now Includes Potent and Highly Selective BCL-2 Candidate BGB-11417

In addition to the established BRUKINSA and tislelizumab programs, BeiGene researchers are working to target other promising pathways to complement our existing medicines and drug candidates and expand our hematology portfolio for greater therapeutic potential, including BCL-2 – a protein known for its aberrant expression in many hematologic malignancies and promotion of cancer cell survival.

BGB-11417 is an investigational potent and highly selective BCL-2 inhibitor with a favorable pharmacokinetics profile. At EHA2021, BeiGene will share preliminary safety data from an ongoing first-in-human Phase 1/1b study (NCT04277637) of BGB-11417 in patients with R/R B-cell malignancies. The Company also plans to evaluate the combination of BGB-11417 and BRUKINSA in patients with MCL and WM in the near future.

BeiGene’s Presentations at EHA2021 Virtual Congress

Abstract #	Abstract Title	Session	Time	Lead Author
Oral Presentation
S207	Tislelizumab (BGB-A317) For Relapsed/Refractory Classical Hodgkin Lymphoma: Long-Term Follow-up Efficacy and Safety Results from A Phase 2 Study	Hodgkin lymphoma – Clinical	Presentation available on Friday, June 11 at 3:00 a.m. ET (9:00 CEST) Live Q&A session on Sunday, June 13 at 10:00 a.m. ET (16:00 CEST)	Yuqin Song, M.D., Ph.D. Beijing Cancer Hospital, China
Posters
EP783	Phase 2 Study of Zanubrutinib In Patients with Relapsed/Refractory Marginal Zone Lymphoma (MAGNOLIA Study)	Indolent and mantle-cell non-Hodgkin lymphoma – Clinical	Friday, June 11 at 3:00 a.m. ET (9:00 CEST)	Stephen Opat, MBBS, FRACP, FRCPA Monash Health and Clinical Hematology Unit Monash University, Australia
EP64-2	Preliminary Results of the Phase 2 Study of Zanubrutinib in Patients with Previously Treated B-Cell Malignancies Intolerant to Ibrutinib and/or Acalabrutinib	Chronic lymphocytic leukemia and related disorders – Clinical	Friday, June 11 at 3:00 a.m. ET (9:00 CEST)	Mazyar Shadman, M.D. Fred Hutchinson Cancer Research Center, University of Washington
EP789	Zanubrutinib In Patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL): Long-Term Efficacy and Safety Results from a Phase 2 Study	Indolent and mantle-cell non-Hodgkin lymphoma – Clinical	Friday, June 11 at 3:00 a.m. ET (9:00 CEST)	Yuqin Song, M.D., Ph.D. Beijing Cancer Hospital, China
EP639	Zanubrutinib Monotherapy in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia: 34-Month Follow-up Results	Chronic lymphocytic leukemia and related disorders – Clinical	Friday, June 11 at 3:00 a.m. ET (9:00 CEST)	Wei Xu, M.D., Ph.D. The First Affiliated Hospital of Nanjing Medical University, China
EP525	Preliminary Safety Data from Patients with Relapsed/Refractory (R/R) B-Cell Malignancies Treated with the Novel B-Cell Lymphoma 2 (Bcl2) Inhibitor BGB-11417	Aggressive Non-Hodgkin lymphoma - Clinical	Friday, June 11 at 3:00 a.m. ET (9:00 CEST)	Chan Y. Cheah, MBBS, FRACP, FRCPA, DMedSc Sir Charles Gairdner Hospital and Pathwest Laboratory Medicine, University of Western Australia Medical School, Linear Clinical Research, Australia
EP805	Efficacy and Safety of Zanubrutinib Versus Rituximab-Based Chemoimmunotherapy in Waldenström Macroglobulinemia: Matching-Adjusted Indirect Comparisons	Indolent and mantle-cell non-Hodgkin lymphoma - Clinical	Friday, June 11 at 3:00 a.m. ET (9:00 CEST)	Jorge J. Castillo, M.D. Dana-Farber Cancer Institute
EP1174	Cost-Effectiveness of Zanubrutinib Versus Ibrutinib in Adult Patients with Waldenström Macroglobulinemia	Quality of life, palliative care, ethics, and health economics	Friday, June 11 at 3:00 a.m. ET (9:00 CEST)	Jorge J. Castillo, M.D. Dana-Farber Cancer Institute

BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 80 clinical trials involving more than 13,000 patients. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company with both mono- and combination therapies prioritized in our research and development. The Company currently markets three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, EUSA Pharma, Bio-Thera, Seagen, Mirati Therapeutics, and Zymeworks. BeiGene has also entered into a collaboration with Novartis Pharma AG granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

About BeiGene

BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are committed to expediting the development of our diverse pipeline of novel therapeutics through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for two billion more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of approximately 6,000 colleagues across five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene's advancement, anticipated clinical development, regulatory milestones and commercialization of drug candidates and medicines in its hematology portfolio, and BeiGene’s plans, commitments, aspirations and goals under the headings “BeiGene Oncology” and “About BeiGene”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates and achieve and maintain profitability; the impact of the COVID-19 pandemic on the BeiGene’s clinical development, regulatory, commercial, and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

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FAQ

What are the key presentations from BeiGene at EHA2021?

BeiGene will present clinical results from the ALPINE and ASPEN trials for BRUKINSA, long-term data for tislelizumab, and preliminary safety data for the BCL-2 inhibitor BGB-11417.

What did the ALPINE trial reveal about BRUKINSA?

The ALPINE trial demonstrated BRUKINSA's superiority in objective response rate and a lower risk of atrial fibrillation compared to ibrutinib.

What is the significance of the ASPEN trial results for BeiGene?

The ASPEN trial results highlight BRUKINSA's improved safety and tolerability profile compared to ibrutinib in treating Waldenström’s macroglobulinemia.

When is the EHA2021 Virtual Congress taking place?

The EHA2021 Virtual Congress is being held from June 9 to June 17, 2021.

What does the long-term follow-up data for tislelizumab show?

Long-term follow-up data for tislelizumab indicated a 76.9% objective response rate in classical Hodgkin’s lymphoma patients.