A Phase 3b, Randomized, Open-Label, Double Crossover Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Adult Patients With IPSS R Intermediate Myelodysplastic Syndrome, Low Blast Acute Myeloid Leukemia, IPSS Intermediate-2 or High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

It is hypothesized that significantly more patients would prefer oral decitabine/cedazuridine to subcutaneous (SC) azacitidine (AZA) due to several factors, including improved treatment convenience, the reduced risk of nosocomial infections, and reduced treatment discomfort. However, this hypothesis has not been formally studied in a controlled setting. This study aims to address this evidence gap and evaluate patient, primary caregiver (carer), and clinician treatment preference between oral decitabine/cedazuridine and SC AZA in the treatment of adult patients with International Prognostic Scoring System-Revised (IPSS-R) intermediate, IPSS intermediate-2, or high-risk myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or low-blast (LB) acute myeloid leukemia (AML) and thereby lend further credibility to the clinical, economic, and patient value of oral decitabine/cedazuridine.

开始日期2023-12-20

申办/合作机构

Otsuka Australia Pharmaceutical Pty Ltd.

NCT05817331 / CompletedN/A

Qualitative Interviews to Refine and Assess the Importance of Constructs, and Ensure the Readability of Patient, Carer, and Clinician Versions of the Treatment Preference in Myelodysplasia Questionnaire (TPMQ): pTPMQ, cTPMQ, and mTPMQ, Respectively

The primary goal of this study is to use qualitative interviews to elicit and confirm concepts related to treatment preferences and understandability of the pTPMQ, cTPMQ, and mTPMQ. The information gathered will be used to support the appropriateness of the questionnaires as a patient-reported, caregiver-reported and clinician-reported outcome measure (PROM) in the population of interest.

开始日期2022-06-28

申办/合作机构

Otsuka Australia Pharmaceutical Pty Ltd.

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2023-11-02·Blood

Phase 3b Study Design for a Comparison of Treatment Preference between Oral Decitabine/Cedazuridine and Azacitidine in Adult Patients with IPSS-R Intermediate Myelodysplastic Syndrome, IPSS Intermediate-2 or High-Risk Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukaemia, or Chronic Myelomonocytic Leukaemia

作者: Keer, Harold N. ; Enjeti, Anoop K ; Fong, Chun Yew ; van Wyk, Greg ; Walton, Richard ; Castaldi, Francesco ; Paine, Taliesha

Myelodysplastic syndromes (MDS) are heterogeneous clonal bone marrow neoplasms characterised by marrow dysplasia, low blood counts and risk of progression to acute myeloid leukaemia (AML).Hypomethylating agents (HMAs) decitabine and azacitidine (AZA) are effective treatments for hematologic cancers including MDS.AZA is indicated to treat International Prognostic Scoring System (IPPS) defined Intermediate-2 (Int-2) and high-risk (HR) MDS, low blast AML (LB-AML; 20-30% blasts) with multi-lineage dysplasia, and chronic myelomonocytic leukaemia (CMML) with 10-29% blasts without myeloproliferative disorder.Oral decitabine/cedazuridine is currently the only oral hypomethylating agent indicated to treat IPSS Int-1, Int-2 or HR MDS and CMML, in the United States, Canada and Australia.AZA administration requires daily visits to a hospital or clinic for 7 days every 28 days, for either intravenous infusions, or large-volume subcutaneous (SC) injections for a minimum of 6 cycles.This places a burden on this patient population, resulting in low treatment adherence, early discontinuation, and subsequently low treatment uptake.Oral decitabine/cedazuridine is administered as one tablet daily for the first 5 days of a 28-day cycle for a minimum of 4 cycles. This allows patients to take their medication at a location of their choice.Alongside previously reported preference for oral therapy, patients may favour oral decitabine/cedazuridine over SC AZA due to improved treatment convenience and reduced discomfort. However, this is untested in a controlled setting. This study aims to evaluate preference between oral decitabine/cedazuridine and SC AZA treatment for adult patients with Revised International Prognostic Scoring System (IPSS-R) intermediate, IPSS Int-2 or HR MDS, LB-AML or CMML.This phase 3b, open-label, multi-centre study (NCT05883956) has sites planned in Australia (4 sites) and New Zealand (5 sites), to compare preference for oral decitabine/cedazuridine (Treatment A) and SC AZA (Treatment B). The study design includes 28 days of screening, four continuous 28-day cycles of study treatment, and a follow-up period with two 28-day cycles of continued therapy. Patients will be randomised to two balanced treatment sequences: ABBA or BAAB (Figure 1). Patients will express a preference twice in the study; after completing Cycle 1 and 2, and after completing Cycle 3 and 4. This cross-over design is twice the length of a typical 2-period AB vs BA design and allows patients to act as their own controls. The study design allows estimation of the treatment effect while mitigating factors that may influence preference. These include the order of treatments, and fluctuations in the patient's physical and disease state over the course of the trial. All available preferences expressed throughout the trial will be used for primary analysis. A total of 42 patients are planned for this study.The primary objective of this study is to compare patients' treatment preference for oral decitabine/cedazuridine and SC AZA for the treatment of MDS, LB-AML or CMML. Secondary objectives include evaluation of carers' and clinicians' treatment preference between oral decitabine/cedazuridine and SC AZA for the treatment and continued treatment of adult patients with MDS, LB-AML or CMML.The primary objective will be assessed by a treatment preference in myelodysplasia questionnaire (pTPMQ), which instructs patients to indicate a preference for injection, oral/tablets or no preference. The secondary objectives will be evaluated by a carer treatment preference in myelodysplasia questionnaire (cTPMQ) and a medical clinician treatment preference in myelodysplasia questionnaire (mTPMQ).Treatment discontinuation rates, quality of life and safety of SC AZA and oral decitabine/cedazuridine will also be compared.The primary analysis will be conducted with a multilevel logistic regression model analysing all available preferences. Descriptive statistics including frequencies, proportions, mean, standard deviation, median, and interquartile range will be used to summarize the study data.When complete, this study will address an evidence gap in the comparison of patient preference for oral decitabine/cedazuridine and SC AZA, and subsequently inform the value of oral decitabine/cedazuridine for the treatment of MDS, LB-AML and CMML.

2023-11-02·Blood

Development of the Treatment Preference in Myelodysplasia Questionnaire (TPMQ) for Clinicians (mTPMQ), Carers (cTPMQ), and Patients (pTPMQ)

作者: Morlock, Robert ; Enjeti, Anoop K ; Fong, Chun Yew ; Paine, Taliesha ; Castaldi, Francesco ; Collett, Donna

Objective: Myelodysplastic syndrome (MDS) is a disease of the hematopoietic stem cells and leads to an increased risk of developing acute myeloid leukemia (AML).[1] The injectable hypomethylating agents (HMA) azacitdine and decibtabine have been shown to be superior to best supportive care in improving cytopenias in intermediate to high-risk patients.[2, 3] These injectable HMAs regimens are commonly administered in a healthcare facility, with patients traveling to the facility on consecutive days. The recent availability of an oral form of decitabine, ASTX 727 (a fixed-dose combination of decitabine and the cytidine deaminase inhibitor cedazuridine), may significantly impact patient, carer, and clinician choices. To assess preference for an injectable vs. orally administered HMA, three questionnaires were developed based on qualitative input from clinicians, patients, and carers: the Treatment Preference in Myelodysplasia Questionnaire (TPMQ) for clinicians (mTPMQ), carers (cTPMQ), and patients (pTPMQ).Methods: This was a non-interventional, cross-sectional qualitative interview study consisting of interviews with patients with MDS who were eligible for or were being/had been treated with injectable azacitidine, their carers and their treating clinicians. Data were collected from qualitative mixed method interviews composed of concept elicitation and cognitive debriefing. Two sites were identified to enrol participants. During concept elicitation, participants were asked about MDS and treatment options to best understand the constructs of interest relative to their specific circumstance and preferences. Cognitive debriefing occurred after participants reviewed a draft of the questionnaire. Based on the interviews, the questionnaires were revised to ensure the constructs of importance were captured and the questionnaires, response options, and instructions were all well understood.Results: 15 participants completed interviews (5 clinicians for the mTPMQ, 5 patients for the pTPMQ, and 5 carers for the cTPMQ). Concepts identified as important included across groups included: easier to be compliant, less travel time, less time in the clinic, less painful, costs and convenience (Table 1).The mTPMQ underwent 3 revisions. Overall, clinicians indicated the directions, items and response options were understandable and clear. Comments that significantly modified the questionnaire concerned splitting the last question from 1 to 2 questions, depending on which treatment the patient would be receiving.Patient participants thought the pTPMQ captured concepts of interest and was easy to understand. Modifications were made to the questionnaire either as a direct result of patient participant comments (e.g., changed skip directions to “turn to page X, question X”), study team discussions of the interviewer's comments and notes and making items consistent between questionnaires.Carer participants thought the cTPMQ captured the constructs of interest and the questions were clear and the questionnaire was easy to answer. Modifications were made to the questionnaire as a direct result of carer participant comments (e.g., changed “We spend less time in the clinic” to “It means less time in the clinic for the patient”), study team discussions of the interviewer's comments and notes (e.g., added “It makes it easier for the patient to continue treatment”) and making items consistent between questionnaires.Conclusions: The findings of the participant interviews suggest the concepts assessed in the assessments are complete. Respondents could respond to items and talk about all aspects assessed in the questionnaires in meaningful ways and were able to comprehend the instructions and response options on a categorical scale. The TPMQs are based on direct input from the population of interest and assess the constructs of importance to each group.1. Bell, J.A., et al., Clin Lymphoma Myeloma Leuk, 2018. 18(4): p. e157-e166.2. Kantarjian, H., et al., Cancer, 2006. 106(8): p. 1794-803.3. Fenaux, P., et al., Lancet Oncol, 2009. 10(3): p. 223-32.

2022-11-15·Blood

Real-World Study Real-World Study of the Use of Azacitidine in Myelodysplasia in Australia

作者: Alam, Arif ; Sillar, Jonathan Robert ; Paine, Taliesha ; Enjeti, Anoop ; Caillet, Vincent ; Ashraf, Asma ; Castaldi, Francesco ; Keer, Harold N.

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2021-10-07

·BioSpace

BeiGene Announces First Regulatory Approval in Australia for BRUKINSA® (Zanubrutinib) for Treatment of Patients with Waldenström’s Macroglobulinemia

Waldenström’s Macroglobulinemia Represents BRUKINSA’s Second Recent Approval in the Asia-Pacific Region, Following October 1 Approval in Singapore for Treatment of Patients with Mantle Cell Lymphoma The TGA approval is based on results from ASPEN, an Australia-inclusive head-to-head clinical trial evaluating BRUKINSA compared to ibrutinib in patients with Waldenström’s macroglobulinemia CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)-- BeiGene Co.,Ltd (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that BRUKINSA® (zanubrutinib) has been approved in Australia for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or in first line treatment for patients unsuitable for chemo-immunotherapy.1 Following registration of BRUKINSA with the Australia Therapeutic Goods Administration (TGA), these patients will have immediate access to BRUKINSA through a BeiGene sponsored post-approval, pre-reimbursement access program. This press release features multimedia. View the full release here: (Photo: Business Wire) In addition, BRUKINSA recently received approval from the Singapore Health Sciences Authority (HSA) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. “BTK inhibition is an established mode of treatment for patients with WM, and the ASPEN trial showed that BRUKINSA is highly effective and has improved tolerability compared to the first-generation BTK inhibitor,” said Professor Con Tam, MBBS, M.D., Disease Group Lead for Low Grade Lymphoma and Chronic Lymphocytic Leukemia at the Peter MacCallum Cancer Centre and a principal investigator on the BRUKINSA clinical program. “BeiGene first began clinical trials of BRUKINSA in Australia in 2013, and since that time, many Australians have benefitted from treatment as part of ongoing clinical studies. We hope this therapy will offer new hope for people living with WM in Australia.” In Australia, more than 6,000 people are diagnosed with non-Hodgkin’s lymphoma (NHL) each year, making it the sixth most common cancer in adults.2 WM is a rare, slow-growing lymphoma that occurs in less than two percent of patients with NHL.3 The disease usually affects older adults and is primarily found in the bone marrow, although it may also impact lymph nodes and the spleen.3 “While WM is a slow-growing lymphoma, not all patients fully respond to existing therapies and many discontinue treatment due to side effects,” commented David Young, the National Team Leader at the WMozzies. “We are pleased to hear that people living with WM in Australia will have immediate access to this next-generation BTK inhibitor that has demonstrated clinical benefit with potential to improve treatment outcomes.” BeiGene has submitted for reimbursement of WM to the Australia Pharmaceutical Benefits Advisory Committee (PBAC). In a first for the PBAC, BeiGene expects to enter a facilitated resolution pathway in order to seek a listing date for the WM indication. “BRUKINSA has been shown to induce deep and durable responses with reduced off-target side effects, suggesting improved clinical benefit compared to standard BTK inhibitor therapy,” said Jane Huang, M.D., Chief Medical Officer, Hematology at BeiGene. “We are grateful to the Australian investigators, patients and families who participated in clinical trials contributing to TGA approval. Our ability to offer BRUKINSA to people in Australia impacted by WM is another step toward fulfilling our goal of increasing affordable access to oncology medicines around the world.” “This approval in Australia, and our recent approval in Singapore, represent BRUKINSA’s continued expansion in the APAC region,” added Adam Roach, Vice President and Head of Commercial for APAC (ex-Greater China) at BeiGene. “We have been building commercial teams in these markets to support our goal of bringing this potential best-in-class BTK inhibitor to patients who need them globally.” The Australian registration for BRUKINSA in WM is based on efficacy results from the ASPEN clinical trial, a Phase 3 randomized, open-label, multicenter trial (NCT03053440) that evaluated BRUKINSA compared to ibrutinib in patients with relapsed or refractory (R/R) or treatment-naïve (TN) WM who harbor a MYD88 mutation (MYD88MUT). In the ASPEN trial, BRUKINSA demonstrated a numerically higher very good partial response (VGPR) rate (28.4%, 95% CI: 20, 38) compared to ibrutinib (19.2%, 95% CI: 12, 28), although the primary endpoint of statistical superiority related to deep response (VGPR or better) was not met. In the ASPEN trial, of the 101 patients with WM randomized and treated with BRUKINSA, 5% of patients discontinued due to adverse events, including cardiomegaly, neutropenia, plasma cell myeloma, and subdural hemorrhage. Adverse events leading to dose reduction occurred in 14.9% of patients, with the most common being neutropenia (3.0%) and diarrhea (2.0%). The overall safety pro BRUKINSA is based on pooled data from 779 patients with B-cell malignancies treated with BRUKINSA in clinical trials. The most common adverse reactions (≥20%) with BRUKINSA were neutropenia, thrombocytopenia, upper respiratory tract infection, hemorrhage/hematoma, rash, bruising, anemia, musculoskeletal pain, diarrhea, pneumonia, and cough. The most common Grade 3 or higher adverse reactions (≥5%) were neutropenia, thrombocytopenia, pneumonia, and anemia. The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions. About BRUKINSA BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues. BRUKINSA is approved in the following indications and regions: For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*; For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**; For the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have received at least one prior therapy (China, June 2020)**; For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021); For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021); Registered and reimbursed for the treatment of MCL in patients who have received at least one prior therapy (Israel, April 2021); For the treatment of adult patients with WM who have received at least one prior therapy (China, June 2021)**; For the treatment of MCL in adult patients who have received at least one prior therapy (Canada, July 2021); For the treatment of MCL in adult patients who have received at least one prior therapy (Chile, July 2021); For the treatment of adult patients with MCL who have received at least one previous therapy (Brazil, August 2021); For the treatment of adult patients with WM (United States, August 2021); For the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen (United States, September 2021)*; For the treatment of adult patients with MCL who have received at least one previous therapy (Singapore, October 2021); and For the treatment of adult patients with WM who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy (Australia, October 2021). To date, more than 30 marketing authorization applications in multiple indications have been submitted in the United States, China, the European Union, and more than 20 other countries or regions. * This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ** This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials. IMPORTANT U.S. SAFETY INFORMATION FOR BRUKINSA (ZANUBRUTINIB) Warnings and Precautions Hemorrhage Fatal and serious hemorrhagic events have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria and hemothorax have been reported in 3.4% of patients treated with BRUKINSA monotherapy. Hemorrhage events of any grade occurred in 35% of patients treated with BRUKINSA monotherapy. Bleeding events have occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Co-administration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage. Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding. Infections Fatal and serious infections (including bacterial, viral, or fungal) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher infections occurred in 27% of patients, most commonly pneumonia. Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Cytopenias Grade 3 or 4 cytopenias, including neutropenia (26%), thrombocytopenia (11%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA monotherapy. Grade 4 neutropenia occurred in 13% of patients, and Grade 4 thrombocytopenia occurred in 3.6% of patients. Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed. Second Primary Malignancies Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA monotherapy. The most frequent second primary malignancy was non-melanoma skin cancer, reported in 8% of patients. Other second primary malignancies included malignant solid tumors (4.0%), melanoma (1.7%) and hematologic malignancies (1.2%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies. Cardiac Arrhythmias Atrial fibrillation and atrial flutter were reported in 3.2% of patients treated with BRUKINSA monotherapy. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher events were reported in 1.1% of patients treated with BRUKINSA monotherapy. Monitor signs and symptoms for atrial fibrillation and atrial flutter and manage as appropriate. Embryo-Fetal Toxicity Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Adverse reactions The most common adverse reactions, including laboratory abnormalities, in ≥ 30% of patients who received BRUKINSA (N = 847) included decreased neutrophil count (54%), upper respiratory tract infection (47%), decreased platelet count (41%), hemorrhage (35%), decreased lymphocyte count (31%), rash (31%) and musculoskeletal pain (30%). Drug Interactions CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily. CYP3A Inducers: Avoid coadministration with moderate or strong CYP3A inducers. Specific Populations Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily. Please see full U.S. Prescribing Information at and Patient Information at . BeiGene Oncology BeiGene is committed to advancing hematology, immuno-oncology and targeted therapies in order to bring impactful and affordable medicines to patients across the globe. We have a growing R&D team of approximately 2,300 colleagues dedicated to advancing more than 90 clinical trials involving more than 13,000 patients and healthy subjects. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 40 countries or regions. We currently market 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 has a high quality, innovative science and medicine organization and is a leader in China with a large oncology focused commercial team. 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 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 expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 7,000 colleagues across five continents. To learn more about BeiGene, please visit 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 plans for development and commercialization of BRUKINSA in Australia, Singapore, the APAC region and other markets, the potential commercial opportunity for BRUKINSA, plans for making BRUKINSA accessible to patients in Australia, the potential for BRUKINSA to be a best-in-class BTK inhibitor and to provide improved clinical benefits to patients, 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. References: 1 BRUKINSA Australia Product Information. Available at . Accessed October 2021. 2 Accessed August 2021. 3 . Accessed August 2021.

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