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
Friday, June 4 at 9:00 a.m. ET
Lin Shen, M.D.
Peking University Cancer Hospital and Institute, China
9102
RATIONALE-307: Tislelizumab plus chemotherapy versus chemotherapy alone as first-line treatment for advanced squamous NSCLC in patients aged ≥65.
Lung Cancer—Non-Small Cell Metastatic
Friday, June 4 at 9:00 a.m. ET
Jie Wang, M .D.
Chinese Academy of Medical Sciences and Peking Union Medical College, China
2569
A Phase 2 study of tislelizumab monotherapy in patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high/mismatch repair deficient solid tumors.
Developmental Therapeutics—Immunotherapy
Friday, June 4 at 9:00 a.m. ET
Jian Li, M.D.
Beijing Cancer Hospital, China
9069
The Effects of Tislelizumab Treatment on the Health-Related Quality of Life of Non−Small Cell Lung Cancer Patients Who Progressed on a Prior Platinum-Containing Regimen.
Lung Cancer—Non-Small Cell Metastatic
Friday, June 4 at 9:00 a.m. ET
Caicun Zhou, M.D., Ph.D.
Shanghai Pulmonary Hospital, Tongji University School of Medicine, China
3109
PARALLEL 303: Phase 2 randomized study of pamiparib vs placebo as maintenance therapy in patients (pts) with inoperable locally advanced or metastatic gastric cancer that responded to platinum-based first-line (1L) chemotherapy.
Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Friday, June 4 at 9:00 a.m. ET
Fortunato Ciardiello, M.D., Ph.D.
Second University of Naples, Italy
1087
A Phase 2 study of pamiparib in the treatment of patients with locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutation.
Breast Cancer—Metastatic
Friday, June 4 at 9:00 a.m. ET
Tao Sun, M.D.
Liaoning Cancer Hospital and Institute, China
2583
AdvanTIG-105: Phase 1 dose-escalation study of anti-TIGIT monoclonal antibody ociperlimab (BGB-A1217) in combination with tislelizumab in patients with advanced solid tumors.
Developmental Therapeutics—Immunotherapy
Friday, June 4 at 9:00 a.m. ET
Sophia Frentzas, M.D.
Monash Health, Monash University School of Medical and Health Sciences, Australia
TPS5595
AdvanTIG-202: A Phase 2 study investigating anti-TIGIT monoclonal antibody ociperlimab plus anti-PD-1 monoclonal antibody tislelizumab in patients with previously treated recurrent or metastatic cervical cancer.
Gynecologic Cancer
Friday, June 4 at 9:00 a.m. ET
Lingying Wu, M.D., Ph.D.
Chines Academy of Medical Sciences, China
TPS4150
AdvanTIG-203: A randomized Phase 2 study comparing anti-TIGIT ociperlimab plus tislelizumab vs tislelizumab plus placebo as second-line treatment in patients with advanced or recurrent esophageal squamous cell carcinoma expressing programmed death-ligand 1
Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Friday, June 4 at 9:00 a.m. ET
Ruihua Xu, M.D., Ph.D.
Sun Yat-Sen University Cancer Center, China
TPS9128
AdvanTIG-302: Anti-TIGIT monoclonal antibody ociperlimab plus tislelizumab vs pembrolizumab in programmed death ligand 1 selected, previously untreated, locally advanced, unresectable, or metastatic non-small cell lung cancer
Lung Cancer—Non-Small Cell Metastatic
Friday, June 4 at 9:00 a.m. ET
Mark A. Socinski, M.D.
AdventHealth Cancer Institute
TPS2656
Zanidatamab, an anti-HER2 bispecific antibody, plus chemotherapy with/without tislelizumab as first-line treatment for patients with advanced HER2-positive breast cancer or gastric/ gastroesophageal junction adenocarcinoma: A Phase 1B/2 trial-in-progress
Developmental Therapeutics—Immunotherapy
Friday, June 4 at 9:00 a.m. ET
Keun Wook Lee, M.D., Ph.D.
Seoul National University Hospital, South Korea
e19506
Preliminary results of the phase 2 study of zanubrutinib in patients with previously treated B-cell malignancies intolerant to ibrutinib and/or acalabrutinib
Abstract Only
N/A
Mazyar Shadman, M.D.
University of Washington, Seattle
e19507
Tislelizumab (BGB-A317) for relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL): long-term follow-up efficacy and safety results from a phase 2 study
Abstract Only
N/A
Yuqin Song, M.D., Ph.D.
Beijing Cancer Hospital, China
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, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, 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.