BeiGene Highlights Progress in Hematology at EHA2021 Virtual Congress

On May 12, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that clinical results from its broad hematology program will be presented at the 26th European Hematology Association (EHA) (Free EHA Whitepaper) 2021 (EHA2021) Virtual Congress being held June 9 – 17, 2021 (Press release, BeiGene, MAY 12, 2021, View Source [SID1234579769]).

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"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 (Free EHA Whitepaper). 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 EHA (Free EHA Whitepaper)2021 Virtual Congress, please visit View Source

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 (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) 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 (Free ASH Whitepaper) 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 EHA (Free EHA Whitepaper)2021.

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 EHA (Free EHA Whitepaper)2021. 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 EHA (Free EHA Whitepaper)2021. Results from the MAGNOLIA trial were previously reported at ASH (Free ASH Whitepaper) 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 EHA (Free EHA Whitepaper)2021, 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 EHA (Free EHA Whitepaper)2021, 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 EHA (Free EHA Whitepaper)2021 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