On April 8, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that clinical results, as well as biomarker data, from its immuno-oncology program in solid tumors will be presented at the American Academy for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (Press release, BeiGene, APR 8, 2022, View Source [SID1234611739]). The AACR (Free AACR Whitepaper) meeting will take place April 8-13, 2022, as a hybrid event in New Orleans and in a virtual format.
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"Through biomarker analyses in patients with solid tumors, we are also beginning to better understand the tumor characteristics that may predict response to tislelizumab and help improve treatment outcomes for patients. We look forward to sharing more details with the medical community in New Orleans."
"Data at AACR (Free AACR Whitepaper) this year build on the growing body of clinical evidence supporting the potential use of tislelizumab for the treatment of non-small cell lung cancer," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors, at BeiGene. "Through biomarker analyses in patients with solid tumors, we are also beginning to better understand the tumor characteristics that may predict response to tislelizumab and help improve treatment outcomes for patients. We look forward to sharing more details with the medical community in New Orleans."
To bring forth potential new treatment options and uncover further insights into checkpoint inhibition in solid tumors and hematological malignancies, BeiGene is evaluating tislelizumab, a potentially differentiated anti-PD-1 antibody, in a broad clinical program, including 17 Phase 3 trials and four pivotal Phase 2 trials, and in collaboration with Novartis.
Growing Body of Data on Tislelizumab in Lung Cancer
RATIONALE-303 and -304 are both Phase 3 studies evaluating tislelizumab in locally advanced or metastatic non-small cell lung cancer (NSCLC). Patient subgroup analyses from these studies will be presented at AACR (Free AACR Whitepaper). Results from these subanalyses reflect and support earlier safety and efficacy findings from those studies.
Additional analyses of early-stage clinical studies evaluating potential biomarkers (tumor mutational burden and gene hyper-amplification) and patient characteristics (co-enrichment of CD8 T cells and macrophages) that may predict response to tislelizumab will be presented.
BeiGene Poster Presentations at the AACR (Free AACR Whitepaper) Annual Meeting 2022
Abstract Information
Date and Time
Presenting Author
Tislelizumab Clinical Data
#CT552: RATIONALE 304: Tislelizumab (TIS) plus chemotherapy versus chemotherapy alone as first line (1L) treatment for non-squamous (non-sq) NSCLC in patients (pts) aged 65–75 years
OPO.CT03.01 – Phase III Clinical Trials
Fri, April 8
12:00 PM ET
Shun Lu
#CT553: Tislelizumab (TIS) versus docetaxel (D) in patients with previously treated advanced non-squamous (non-sq) non-small-cell lung cancer (NSCLC): subanalysis from the RATIONALE-303 Phase 3 randomized clinical study
OPO.CT03.01 – Phase III Clinical Trials
Fri, April 8
12:00 PM ET
Ying Cheng
#CT554: Tislelizumab (TIS) versus docetaxel (D) in patients with previously treated advanced squamous (sq) non-small-cell lung cancer (NSCLC): Sub-analysis from phase 3 RATIONALE-303 randomized clinical study
OPO.CT03.01 – Phase III Clinical Trials
Fri, April 8
12:00 PM ET
Jie Wang
Biomarker Clinical Data
#LB511: The combination of hyper-amplification and tumor mutational burden as a pan-cancer biomarker in patients treated with tislelizumab
OPO.CL11.01 – Biomarkers
Fri, April 8
12:00 PM ET
Jayesh Desai
#LB512: RATIONALE-304: The association of tumor mutational burden (TMB) with clinical outcomes of tislelizumab (TIS) + chemotherapy (chemo) versus chemo alone as first-line treatment for advanced non-squamous non-small cell lung cancer (nsq-NSCLC)
OPO.CL11.01 – Biomarkers
Fri, April 8
12:00 PM ET
Shun Lu
#LB514: CD8 T cells and macrophage abundances associated with clinical benefit of tislelizumab in various tumor types
OPO.CL11.01 – Biomarkers
Fri, April 8
12:00 PM ET
Jingwen Shi
Other Data
#5338: Pamiparib as a non-P-glycoprotein substrate PARP inhibitor can overcome ABCB1-mediated drug resistance in ovarian cancer cells
OPO.ET03.01 – Drug Resistance
Fri, April 8
12:00 PM ET
Minjuan Deng
#5421: Prediction of intratumoral TIGIT receptor occupancy after the treatment with anti-TIGIT antibodies
OPO.ET05.01 – Pharmacology, Pharmacogenetics, and Pharmacogenomics
Fri, April 8
12:00 PM ET
Oleg Demin Jr
#5541: BGB-15025, a potent and selective HPK1 inhibitor is efficacious as a single agent or in combination with PD-1 antibody in multiple tumor models
OPO.IM02.01 – Preclinical Immunotherapy
Fri, April 8
12:00 PM ET
Ye Liu
About Tislelizumab
Tislelizumab is an anti-programmed death receptor-1 (PD-1) inhibitor designed to help aid the body’s immune cells to detect and fight tumors. Tislelizumab, a humanized monoclonal antibody, is specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.
Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene has initiated or completed more than 20 potentially registration-enabling clinical trials in 35 countries and regions, including 17 Phase 3 trials and four pivotal Phase 2 trials.
Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment in seven indications, including multiple approvals in NSCLC. Tislelizumab has been submitted for regulatory review in two additional indications in China and as a potential treatment for unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy in the US, and in NSCLC and ESCC in Europe. In January 2021, BeiGene partnered with Novartis to accelerate the clinical development and marketing of tislelizumab in the US, EU and Japan.
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 and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. 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. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and Great Britain, Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the 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, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.
In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced two new agreements in December 2021 granting Novartis an option to co-develop, manufacture, and commercialize BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development and adding five approved Novartis oncology products to the BeiGene product portfolio across designated regions of China.