BeiGene to Showcase Broad Clinical Portfolio at 2021 ASCO Annual Meeting

On May 19, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, reported that clinical results and updates from its broad portfolio will be presented at the 2021 Annual Meeting of the American Society of Cancer Oncology (ASCO) (Free ASCO Whitepaper) being held June 4 – 8, 2021 (Press release, BeiGene, MAY 19, 2021, View Source [SID1234580256]).

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"We are pleased to share updates from our growing clinical portfolio across solid tumors and hematologic malignancies at this year’s ASCO (Free ASCO Whitepaper), including multiple novel combinations of tislelizumab with our investigational Fc-competent anti-TIGIT-antibody ociperlimab and other therapeutic agents, and the ongoing evaluation of our next-generation BTK inhibitor zanubrutinib," commented Lai Wang, Ph.D., Global Head of R&D at BeiGene. "We believe that these presentations underscore the breadth and diversity, as well as the remarkable progress and momentum, in BeiGene’s integrated global clinical development program, which we hope will lead to innovative new medicines that offer expanded access and improved affordability for patients worldwide. Through our R&D approach, we share ASCO (Free ASCO Whitepaper)’s ambition of promoting greater health equity for all patients regardless of where they live."

To learn more about BeiGene’s research and development and activities around ASCO (Free ASCO Whitepaper), please visit View Source All presentations will be available on Friday, June 4 at 9:00 a.m. ET on ASCO (Free ASCO Whitepaper) Digital Program.

BeiGene’s Diverse Research and Development Program Designed to Address Unmet Patient Needs

BeiGene takes a diverse approach in its research and development efforts by evaluating different mechanisms of action in prevalent cancer types by biomarker, histology, and line of therapy in a broad, global clinical program. At ASCO (Free ASCO Whitepaper) 2021, some of the highlights include:

Initial report from the Phase 3 RATIONALE 302 trial (NCT03430843) of tislelizumab in second-line advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC);
Initial report from the Phase 2 trial (NCT03736889) of tislelizumab in patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors; and
Long-term follow-up efficacy and safety results from the pivotal Phase 2 trial (NCT03209973) in patients with relapsed or refractory classical Hodgkin’s lymphoma (cHL).
Novel Combination Trials with Tislelizumab Designed to Improve the Clinical Benefit of Checkpoint Inhibition

Although checkpoint inhibition has revolutionized cancer treatment over the past decade, tumor immune escape induced by many mechanisms and factors presents limitations in clinical benefit. To address this issue, BeiGene has been evaluating its potentially differentiated anti-PD-1 antibody tislelizumab in a broad program combining tislelizumab with over 14 therapies or therapeutic candidates, from chemotherapies and targeted therapies to other immunotherapies, and will be presenting results or trial design details on three of these combinations – with BeiGene’s investigational anti-TIGIT-antibody ociperlimab, with chemotherapy, and with investigational anti-HER2 bispecific antibody zanidatamab (ZW25), licensed from Zymeworks, at ASCO (Free ASCO Whitepaper) 2021.

Ongoing Evaluation of Next-Generation BTK Inhibitor BRUKINSA

BTK inhibition has become an emerging standard of care in B-cell malignancies, but not all patients respond to treatment with BTK inhibitors and adverse events are the most common reason for treatment discontinuation. BeiGene’s next-generation BTK inhibitor BRUKINSA (zanubrutinib) was designed to maximize BTK occupancy and minimize off-target binding for improved efficacy and decreased side effects compared to the first-generation BTK inhibitor.

At ASCO (Free ASCO Whitepaper) 2021, updated data from the Phase 2 trial (NCT04116437) of zanubrutinib in patients with previously treated B-cell malignancies who were intolerant to prior BTK inhibitors will be available in an abstract. 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 the other BTK inhibitors ibrutinib and/or acalabrutinib 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 zanubrutinib. Updated results will also be available in a poster at the upcoming EHA (Free EHA Whitepaper)2021 Virtual Congress.

BeiGene recently announced positive results from a planned interim analysis in the Phase 3 ALPINE trial comparing BRUKINSA against ibrutinib in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). BRUKINSA demonstrated superiority in objective response rate 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.

BeiGene’s Presentations at 2021 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract #

Title

Session

Time

Lead Author

4012

RATIONALE 302: Randomized, Phase 3 study of tislelizumab vs chemotherapy as second-line treatment for advanced unresectable/metastatic esophageal squamous cell carcinoma.

Poster Discussion Session, Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary