Beone Medicines Ltd. Class A · SSE:688235
Beone Medicines Ltd. Class A — BeiGene — Technical Presentation (June 2019)
48 slides from Beone Medicines Ltd. Class A's technical presentation, Jun 20, 2019
Slide 1: BeiGene Mid-Year 2019 Clinical Data Wrap-Up
Exhibit 99.1 BeiGene Mid-Year 2019 Clinical Data Wrap-Up June 20, 2019
Slide 2: Welcome
Welcome Howard Liang, Ph.D., CFO and Chief Strategy Officer 2
Slide 3: Disclosures
Certain statements contained in this presentation and in the accompanying oral presentation, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements. Disclosures Examples of such forward-looking statements include those regarding
Slide 4: Agenda
Agenda Welcome – Howard Liang, Ph.D. Introduction – John V. Oyler Zanubrutinib – Jane Huang, M.D. • Pooled safety data summary • Phase 3 in WM: MYD88WT cohort • Phase 2 in R/R CLL/SLL • Phase 1 in WM cohort • Phase 1 in MCL cohort • Phase 2 in R/R MCL summary • Phase 1b Combination with Obinutuzumab
Slide 5: Introduction
Introduction John V. Oyler, Chairman, Co-Founder and CEO 5
Slide 6: Business Updates
Business Updates Regaining tislelizumab worldwide rights • Termination of collaboration agreement with Celgene ahead of pending BMS-Celgene merger • BeiGene to receive $150M payment from Celgene • Early resolution in the best interest of the asset and both companies • Minimal interruption in clinica
Slide 7: Tislelizumab's Advanced Development Status
Tislelizumab’s Advanced Development Status Phase 3 (n=800) in 2L NSCLC Enrollment complete tislelizumab vs. docetaxel NSCLC Primary endpoint: OS Initiated in Nov. 2017 Enrollment expected to complete in 2019 Phase 3 (n=640) in 1L HCC Phase 2 (n=225) in 2L/3L HCC tislelizumab vs. sorafenib tislelizum
Slide 8: Zanubrutinib
Zanubrutinib Jane Huang, M.D., CMO, Hematology
Slide 9: Zanubrutinib Pooled Safety
Zanubrutinib Pooled Safety Abstract PS1159 24th European Hematology Association Congress Jane Huang, M.D., CMO, Hematology 9
Slide 10: Zanubrutinib Monotherapy Studies Pooled Safety Data
Zanubrutinib Monotherapy Studies Pooled Safety Data (n=682) M ost Common AEs (All Grade in ≥10% or Grade 3 or Higher in ≥ 3%) AEs of Interest by Category % of patients with ≥ 1 AE of interest Infections Bleeding (petechiae/contusion/hemorrhage)* Neutropenia Thrombocytopenia Anemia Grade 1-2 Hyperten
Slide 11: Pooled Safety Data
Pooled Safety Data* Zanubrutinib Zanubrutinib Acalabrutinib6 Ibrutinib Background EHA 20181 EHA 20192 Rate n 476 682 612 7565; 1,124b; 2,0904-2,1523 1,605c Major hemorrhage % 2% 2.5% 2.8% 4%5 (Gr≥3) (2%) (2.1%) (2.0%) 3%5 [events/100 pt. yrs.] [2.07] - [3.03] [1.93] Atrial fibrillation % ~2% 1.9% 2.
Slide 12: Zanubrutinib Phase 3 in WM: MYD88WT Cohort
Zanubrutinib Phase 3 in WM: MYD88WT Cohort Abstract PF487 24th European Hematology Association Congress Jane Huang, M.D., CMO, Hematology 12
Slide 13: Trial Design: Phase 3 in WM, MYD88WT Cohort
WT Trial Design: Phase 3 in WM, MYD88 Cohort Data cut: Feb 28, 2019 Ar m A Cohort 1: R/R or TN* WM with MYD88L265P Mutation Zanubrutinib 160 mg bid until PD MYD88MUT WM patients R (n=201) 1:1 Ar m B Ibrutinib Stratification factors: 420mg qd until PD • CXCR4 mutational status (CXCR4WHIM vs CXCR4WT o
Slide 14: Patient and Disease Characteristics
Patient and Disease Characteristics Data cut: Feb 28, 2019 Characteristic Total (n=26) Age, years, median (range) 71.5 (39-87) Gender, n (%) Male 14 (53.8) Female 12 (46.2) ECOG performance status, n (%) 0 9 (34.6) 1 14 (53.8) 2 3 (11.5) Prior treatment status Treatment-naïve, n (%) 5 (19.2) Relapse
Slide 15: Best Response
Best Response Data cut: Feb 28, 2019 Total Best response, n (%) (n=26) Overall response rate (ORR) 21 (80.8) Major response rate (MRR, PR or better) 14 (53.8) VGPR 6 (23.1)a,b PR 8 (30.8)b MR 7 (26.9) SD 4 (15.4) PD 1 (3.8) Time to MR, med (range), mo Months 2.9 (1.9 -7.4) Study follow-up time, med
Slide 16: Adverse Events Overview
Adverse Events Overview Data cut: Feb 28, 2019 Treatment Emergent Adverse Event n (%) 2 patients discontinued due to AEs Patients w ith ≥1 AE grade ≥3 12 (46.2) • Grade 4 subdural hemorrhage Patients w ith ≥1 serious AE 8 (30.8) • Grade 3 diarrhea a AE leading to treatment discontinuation 2 (7.7) Ma
Slide 17: MYD88WT Cohort Results Consistent with Phase 1
Zanubrutinib Cohort 2 MYD88WT Results Consistent with Phase 1 Data cut: Feb 28, 2019 Be st re sponse , Phase 3 cohort 2 Phase 11 n (%) (n=26) (n=8) EHA 2019 ORR 21 (80.8) 7(87.5) MRR 14 (53.8) 5(62.5) CR / VGPR 6 (23.1)a,b 2(25.0) PR 8 (30.8) 3(37.5) MR 7 (26.9) 2(25.0) SD 4 (15.4) 1(12.5) PD 1 (3.8
Slide 18: Zanubrutinib Phase 2 in R/R CLL/SLL in China
Zanubrutinib Phase 2 in R/R CLL/SLL in China (ICML) Abstract 015 15th International Conference on Malignant Lymphoma Jane Huang, M.D., CMO, Hematology 18
Slide 19: Trial Design: Phase 2 in R/R CLL/SLL in China
Trial Design: Phase 2 in R/R CLL/SLL in China R/R CLL/SLL Key Criteria Zanubrutinib 160 mg bid Inclusion Criteria until progression, intolerable toxicity, • ≥18 years old or end of study • At least one treatment indication • Measurable lesion Exclusion Criteria • Richter syndrome Objectives • Insuff
Slide 20: Patient and Disease Characteristics
Patient and Disease Characteristics Data cut: Dec 14, 2018 Baseline Characteristics n = 91 Baseline Characteristics n = 91 Median age (range), years 61.0 (35 - 87) Splenomegaly, n (%) 56 (61.5) Male, n (%) 52 (57.1) Hepatomegaly, n (%) 11 (12.1) Late stage a, n (%) 63 (69.2) Absolute lymphocyte coun
Slide 21: Best Response
Best Response Data cut: Dec 14, 2018 Response by IRC n = 91 ORR including PR-L, n (%) 77 (84.6) BOR, n (%) Complete response (CR) 3 (3.3) Partial response (PR) 54 (59.3) Partial response with lymphocytosis (PR-L) 20 (22.0) Stable disease (SD) 4 (4.4) Progressive disease (PD) 4 (4.4) Not evaluable a
Slide 22: Progression-Free Survival
Progression-Free Survival Data cut: Dec 14, 2018 100 The median follow-up 90 time for PFS was 12.9 80 92.2% at 6 months months (0.8, 20.4) (95% CI: 84.3, 96.2) 87.2% at 12 months 70 Median PFS has (95% CI: 78.0, 92.7) not been reached 60 50 40 30 20 10 + Censored Progression - Free Survival Probabil
Slide 23: TEAE Regardless of Causality
TEAE Regardless of Causality Data cut: Dec 14, 2018 Serious AEs were reported TEAE with Frequency ≥10% in 33% patients and grade ≥3 Neutrophil count decreased AEs were reported in 76%. Upper respiratory tract infection Purpura Platelet count decreased There were 8 patients reported Haematuria AEs le
Slide 24: Ibrutinib in Chinese Patients with R/R CLL
Ibrutinib in Chinese Patients with R/R CLL Ibrutinib Trial PCI-32765CLL3002* Arms Ibrutinib Rituximab Investigator Investigator n 107 53 mFU months 17.8 ORR% (w/o PR-L) 45% 5.6% ORR% (including lymphocytosis) 57% 5.6% CR 1.9% 0 PR 43% 5.6% PR-L 11% 0 AEs, n (%); Ibrutinib (n=86) All Grade (%) Grade
Slide 25: Other Zanubrutinib Studies
Other Zanubrutinib Studies Jane Huang, M.D., CMO, Hematology 25
Slide 26: Updated WM Cohort Safety and Efficacy from Global Phase 1
Updated WM Cohort Safety and Efficacy from Global Phase 1 (EHA) Data cut: Sep 16, 2018 Be st re sponse , All Efficacy TN Patients (n=24) R/R Patients (n=49) n (%) Evaluable (n=73) ORR 67 (92) 23 (96) 44 (90) CR 1(1) 0(0) 1(2) VGPR 30 (41) 7 (29) 23 (47) PR 29 (40) 14 (58) 15 (31) MR 7 (10) 2 (8) 5 (
Slide 27: Updated MCL Cohort Safety and Efficacy from Global Phase 1
Updated MCL Cohort Safety and Efficacy from Global Phase 1 (ICML) Data cut: Dec 13, 2018 Be st re sponse , All Efficacy TN (n=11) R/R (n=37) n (%) Evaluable (n=48) Follow-up for efficacy-evaluable pts, 16.7 8.3 19.4 median (range), mo (1.6-38.2) (1.6-27.9) (1.9-38.2) ORR, n (%) 41 (85.4) 9 (81.8) 32
Slide 28: Updated Data from Zanubrutinib Phase 2 China Pivotal Study in R/R MCL
Updated Data from Zanubrutinib Phase 2 China Pivotal Study in R/R MCL (ICML) Data cut: Feb 15, 2019 Best response, n (%) Data cutoff Mar 2018 Data cutoff Feb n = 85a 15, 2019 n = 86 INV IRC INV ORR 72 (84.7) 71 (83.5) 72 (83.7) CR 62 (72.9) 50 (58.8) 67 (77.9) PR 10 (11.8) 21 (24.7) 5 (5.8) SD 1 (1.
Slide 29: Zanubrutinib with Obinutuzumab: Updated Data
Updated Data from Zanubrutinib in Combination with Obinutuzumab Remains Consistent in More Patients TN CLL/SLL R/R CLL/SLL R/R FL (n = 20) (n = 25) (n = 36) Follow-up median (range), mo 28.8 (13.9 - 34.8) 28.9 (7.9 – 36.9) 20.1 (2.3-37.2) Best response, n (%) ORR 20 (100.0) 23 (92.0) 26 (72.2) CR* 6
Slide 30: Tislelizumab
Tislelizumab Eric Hedrick, M.D., Chief Advisor
Slide 31: Tislelizumab Pivotal Phase 2 in R/R cHL
Tislelizumab Pivotal Phase 2 in R/R cHL (EHA) Abstract PF469 24th European Hematology Association Congress Eric Hedrick, M.D., Chief Advisor 31
Slide 32: Trial Design: Tislelizumab in Phase 2 in R/R cHL
Trial Design: Tislelizumab in Phase 2 in R/R cHL Primary endpoint: Tislelizumab - ORR assessed by IRC 200 mg IV Q3W R/R cHL (n=70) Continue treatment until Key Secondary endpoints: PD, unacceptable toxicity, - DOR, PFS, CR rate, TTR or end of study Patients with R/R HL • Failed to achieve a response
Slide 33: Patient and Disease Characteristics
Patient and Disease Characteristics Data cut: Nov 26, 2018 Baseline Characteristics Total (n=70) Age (years), median (range) 32.5 (18, 69) Age group <65 / 65-74 years, n (%) 66 (94.3) / 4 (5.7) Sex, male / female, n (%) 40 (57.1) / 30 (42.9) Time since first diagnosis of cHL (months), median (range)
Slide 34: Best Responses
Best Responses Data cut: Nov 26, 2018 Be st re sponse*, n ( %) n=70 IRC ORR (CR+PR), n (%) [95% CI]† 61 (87.1) [77,93.9] Complete response 44 (62.9) Partial response 17 (24.3) Stable disease 3 (4.3) Progressive disease 5 (7.1) Died before any postbaseline tumor assessment‡ 1 (1.4) *Response Criteria
Slide 35: Summary of Adverse Events
Summary of Adverse Events Data cut: Nov 26, 2018 Consistent type and frequency of immune-related AEs TEAE, n (%) n=70 Grade ≥3 TEAE 21 (30) TEAEs in ≥10% of Patients or Grade ≥3 TEAEs Serious TEAE 12* (17.1) in ≥2 Patients Regardless of Causality † TEAE leading to treatment discontinuation 4 (5.7) P
Slide 36: Progression-Free Survival – 91% of CRs Were Ongoing
Progression-Free Survival – 91% of CRs Were Ongoing Data cut: Nov 26, 2018 40 of 44 CR’s and 10 of 17 PRs ongoing Figure out these numbers. 1.0 95.7% + Censored 82.1% 0.8 - Fr ee 0.6 0.4 Progression Survival Probability* 0.2 0.0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Time (months) At Risk 70 70
Slide 37: Durability of CRs on Tislelizumab Similar to Other PD-1 Antibodies
Durability of CRs on Tislelizumab Appears Similar to Other PD-1 Antibodies in cHL* Data cut: Nov 26, 2018 Tislelizumab DOR curves by response Nivolumab DOR curves by response BGB-A317-203 CM-205 study *Data from separate trials. Limitations regarding cross-trial comparisons apply. *Response criteria
Slide 38: Tislelizumab in NPC (ASCO)
Tislelizumab in NPC (ASCO) Abstract 2556 American Society of Clinical Oncology Eric Hedrick, M.D., Chief Advisor 38
Slide 39: Tislelizumab Nasopharyngeal Carcinoma Cohort from Global Phase 1
Tislelizumab Nasopharyngeal Carcinoma Cohort from Global Phase 1 NPC (n=21) Preliminary Antitumor Activity Median age, years (min, max) 48 (35, 61) Male 17 (81) • A total of 21 patients were evaluable for antitumor Sex Female 4 (19) activity, defined as any patient who had measurable Prior anticance
Slide 40: Key Takeaways
Key Takeaways Eric Hedrick, M.D., Chief Advisor 40
Slide 41: Zanubrutinib Key Takeaways
Zanubrutinib Key Takeaways • Results from non-randomized MYD88WT cohort of Phase 3 trial in WM confirmed activity of zanubrutinib in this difficult- to-treat population, with ORR and VGPR rates consistent with results from MYD88WT patients treated in Phase 1 • First presentation of pivotal Phase 2 d
Slide 42: Tislelizumab Key Takeaways
Tislelizumab Key Takeaways • Follow-up from the Phase 2 study of tislelizumab in Chinese patients with classical Hodgkin’s lymphoma confirms a high complete response rate and encouraging durability of complete responses • ASCO data show encouraging activity of tislelizumab in nasopharyngeal cancer a
Slide 43: Q&A
Q&A 43
Slide 44: Thank You
Thank You 44
Slide 45: Backup
Backup 45
Slide 46: PD-1 Inhibitor Data in R/R cHL: Pembrolizumab and Nivolumab
PD-1 Inhibitor Data in R/R cHL* Pembrolizumab and Nivolumab Pembrolizumab1 Nivolumab2 Company Mer c k BMS n 210 243 A SCT-ineligible OR A SCT-failure Eligibility A SCT-failure Prior brentuximab vedotina Prior brentuximab vedotina Prior Lines, med (range) 4 (1-12) 4 (2-15) Prior therapy A SCT 129 (61
Slide 47: Reported PD-1 Inhibitor Data in R/R cHL: Sintilimab and Camrelizumab
Reported PD-1 Inhibitor Data in R/R cHL* Sintilimaband Camrelizumab Sintilimab1 Camrelizumab2 Company Innovent Hengrui n 96 66 Eligibility > 2 prior lines of therapya > 2 prior lines of therapya Prior Lines, med (range) 3 (1-13) 3 (2-10) Prior therapy A SCT 18 (19%) 9 (14%) Brentuximab Vedotin NR 5
Slide 48: Reported PD-1 Inhibitor Data in R/R cHL: Tislelizumab
Reported PD-1 Inhibitor Data in R/R cHL Tislelizumab Tislelizumab1 Company BeiGene n 70 A SCT-ineligible Eligibility A SCT-failure Prior Lines, med (range) 3 (2-11) Prior therapy A SCT 13 (19%) Brentuximab Vedotin 4 (5.7%) Follow -up (med) 13 mo Response Criteria Lugano 2014 ORR 87% CR 63% PR 24% SD