Beone Medicines Ltd. Class A · SSE:688235
Beone Medicines Ltd. Class A — BeiGene — Investor Presentation (January 2021)
69 slides from Beone Medicines Ltd. Class A's investor presentation, Jan 11, 2021
Slide 1: BeiGene Corporate Presentation
BeiGene Corporate Presentation January 10, 2021 Exhibit 99.1
Slide 2: Disclosures
2 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. Examples of such forward-looking statements include statements reg
Slide 3: Fully-Integrated Global Biotech Company with Unique Strategic Competitive Advantages
Key Potential 2021 catalysts • Up to 12 commercial products • Multiple commercial launches and reimbursement opportunities for tislelizumab and BRUKINSA • Key Phase 3 readouts: BRUKINSA CLL • Internal pipeline advancements: ociperlimab (TIGIT), Bcl-2 Global 5,000+ organization • 10 offices on 5 cont
Slide 4: Transformational Collaboration with Amgen
4 Transformational Collaboration with Amgen Validates BeiGene’s China-inclusive global development and commercial capabilities • Collaboration rationale – Joining forces to fight one common enemy: cancer – Expected to accelerate access to important oncology medicines for patients in China and global
Slide 5: Regulatory Reforms and Reimbursement Expansion in China Create a Historical Opportunity
5 Regulatory Reforms and Reimbursement Expansion in China Create a Historical Opportunity for the Industry Source: 1. Trialtrove; Industry association; 2. BeiGene analysis 0% 5% 10% 15% 20% 25% 30% 0 3 6 9 12 15 18 21 1 2 3 4 5 6 T h o u s a n d s China’s Rising Share in Global Trials1 Series1 Serie
Slide 6: Our Strategies for Building a Leading Global Innovative Biotech Company from China
6 Our Strategies for Building a Leading Global Innovative Biotech Company from China Realize two large internally-developed near-term commercial opportunities • BRUKINSA (zanubrutinib) for the global market as a potentially best-in-class BTK inhibitor • Tislelizumab as a uniquely designed PD-1 antib
Slide 7: BRUKINSA (Zanubrutinib) Overview
7 BRUKINSA (Zanubrutinib) Overview Potentially best-in-class BTK inhibitor Sources: 1. ICML 2019 Song et. al.; 2. ASCO 2020 Tam et. al.; 3. Cull et. al. ASH 2019; 4. Tam et. al. ASH 2019; 5. As of January 10, 2021. BTK: Bruton’s tyrosine kinase; CLL/SLL: chronic lymphocytic leukemia/small lymphocyti
Slide 8: BRUKINSA Nine filed or potentially registration-enabling studies
8 BRUKINSA (Zanubrutinib) Overview Nine filed or potentially registration-enabling studies ^Time of the announcement of the enrollment completion; 1L: First Line; CLL/SLL: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; CR: Complete Response; DLBCL: Diffuse Large B-Cell Lymphoma; FL: Follic
Slide 9: Tislelizumab Overview
9 Tislelizumab Overview PD-1 inhibitor developed globally, targeting Asia-prevalent tumors ADVANTAGES • Differentiated mechanism: minimized binding to FcγR • Differentiated Hodgkin’s data with high CR rate; strong clinical data in lung cancer with three Phase 3 trials having read out positively at i
Slide 10: Tislelizumab Broad Late-stage Development Program
10 Tislelizumab Broad Late-stage Development Program Sixteen filed or potentially registration-enabling studies ^Time of the announcement of the enrollment completion; *Tislelizumab dosage 200mg every three weeks, Q3W. Global Ph2 in R/R/ NK/T-cell lymphoma and Ph2 trial in MSI-H or dMMR solid tumors
Slide 11: Commercial Footprint in Two Largest Pharmaceutical Markets
16% 9% 55% 17% 3% ABRAXANE REVLIMID VIDAZA tislelizumab BRUKINSA XGEVA $16M $23M $31M $38M $38M $57M $58M $50M* $57M $52M^ $66M $91M 0 20 40 60 80 100 11 Commercial Footprint in Two Largest Pharmaceutical Markets with a Science and Medicine-Based Team 1. As of January 8, 2021; * Sales negatively imp
Slide 12: Running Global Trials of the Highest Quality Incorporating China
12 Running Global Trials of the Highest Quality Incorporating China BeiGene trials in over 35 countries & regions • Global clinical development organization of over 1,600+ people across 10 offices and 5 continents • Over 11,000 subjects enrolled by BeiGene • Running 60+ clinical trials in over 35 co
Slide 13: Research Delivered Molecules to the Clinic in Its First 10 Years
13 Research Delivered 11 Molecules to the Clinic in Its First 10 Years Beijing Research Center (ONLY 1ST AND 2ND FLOOR) • Team size <200 • 6-8 preclinical programs Beijing Research Center Shanghai Research Center • Team size ~500 • ~12 preclinical programs Beijing Research Center Shanghai Research C
Slide 14: Strong Manufacturing Capabilities
• Future planned capacity >120,000L, can accommodate expansion to >200,000L • Current: 64,000L; Future: Guangzhou expansion >60,000L, US expansion planned • Lyophilization and liquid fill, 10 fill/finish lines, 3 packaging lines, pilot API, dual source BTK API planned 14 Strong Manufacturing Capabil
Slide 15: Commercial Products
PRODUCT LEAD INDICATIONS MECHANISM OF ACTION REGULATORY STATUS COMMERCIAL RIGHTS 2019 GLOBAL SALES PARTNER R/R MCL (U.S.) / R/R MCL and R/R CLL/SLL (China) BTK inhibitor Approved in the U.S./ Approved in China Global NA N/A R/R classical Hodgkin’s lymphoma / R/R PD-L1+ urothelial carcinoma Anti-PD-1
Slide 16: BeiGene's Internal Pipeline
16 BeiGene’s Internal Pipeline Three late-stage, and eight early-stage clinical assets *Some indications will not require a non-pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or Ph3 clinical trials. **Confirmatory clinical trials post approval are required for accelerated approvals. † R/R
Slide 17: BeiGene's Collaborative Pipeline
17 BeiGene’s Collaborative Pipeline Over 20 compounds * Some indications will not require a non-pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or Ph3 clinical trials. **Confirmatory clinical trials post approval are required for accelerated approvals. ^ BiTE, ^^ HLE BiTE, † ZW25, AML: acu
Slide 18: Striving to Be the Partner of Choice
18 Striving to Be the Partner of Choice Leveraging China for global clinical development ADC: antibody-drug conjugate; HER2: human epidermal growth factor receptor 2. • Potential to accelerate global trials through heavily China-inclusive clinical development – Hard-to-recreate ability, and scale –
Slide 19: Financial Summary
19 Financial Summary Selected Financials Three Months Ended Nine Months Ended Amounts in millions of U.S. dollars Sept 30, 2020 (unaudited) Sept 30, 2019 (unaudited) Sept 30, 2020 (unaudited) Sept 30, 2019 (unaudited) Total Revenue $ 91 $ 50 $ 209 $ 371 Product revenue, net 91 55 209 166 Collaborati
Slide 20: Upcoming Milestones and Catalysts
20 Upcoming Milestones and Catalysts BRUKINSA® (zanubrutinib, BTK Inhibitor) Timing Regulatory Regulatory Regulatory Regulatory Data Data Enrollment Continue discussion of ASPEN data with U.S. FDA File sNDA for MZL in China Potential sNDA approval for WM in China; potential approvals in Canada
Slide 21: Upcoming Milestones and Catalysts: Partnered Assets
21 Upcoming Milestones and Catalysts Partnered Assets Timing Regulatory Regulatory Regulatory Regulatory Data Enrollment Potential approval of QARZIBA for high-risk neuroblastoma in China Potential approval of KYPROLIS for R/R MM in China Potential approval of SYLVANT for multicentric Castlema
Slide 22: Key Takeaways
22 Key Takeaways • BeiGene has an established platform to leverage the highly impactful developments in China – Strategic collaboration with Amgen provides validation of our clinical and commercial capabilities • A compelling emerging growth story with up to 12 products on market by YE 2021 – Robust
Slide 23: Review of Product Candidates
Review of Product Candidates
Slide 24: Overview of Zanubrutinib (BGB-3111)
24 Overview of Zanubrutinib (BGB-3111) Potentially best-in-class BTK inhibitor OVERVIEW • Optimized pharmacologic properties relative to ibrutinib: superior bioavailability and higher selectivity • Development hypothesis: more complete target inhibition, deeper responses, and favorable safety profil
Slide 25: Zanubrutinib Clinical Program
25 Zanubrutinib Clinical Program * Some indications will not require a non-pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or Ph3 clinical trials. ** Confirmatory clinical trials post approval are required for accelerated approvals. 1. as of 06.15.20. 2. global study and potentially regist
Slide 26: Zanubrutinib pharmacokinetics versus ibrutinib and acalabrutinib
0 100 200 300 400 500 600 700 0 6 12 18 24 Time post-dose (hours) Series1 0 100 200 300 400 500 600 700 0 6 12 18 24 Time post-dose (hours) Series1 Adapted from Advani et al., JCO, 2013 • Cmax and AUC of zanubrutinib at 80mg QD appear to be similar to those of ibrutinib at 560mg • Free drug exposure
Slide 27: ASPEN Topline Efficacy Summary
27 ASPEN Topline Efficacy Summary Response Rate* Relapsed or Refractory† Overall† Overall August 2019‡ Overall January 2020^ Zanubrutinib (N = 83) Ibrutinib (N = 81) Zanubrutinib (N = 102) Ibrutinib (N = 99) Zanubrutinib (N = 102) Ibrutinib (N = 99) Zanubrutinib (N = 102) Ibrutinib (N = 99) CR 0 0 0
Slide 28: ASPEN: Progression-Free and Overall Survival in ITT population
28 ASPEN: Progression-Free and Overall Survival in ITT population Source: Tam et. al., ASCO 2020 IRC, independent review committee; VGPR, very good partial response. Disease progression determined by IRC. No. of Subjects at Risk No. of Subjects at Risk Event-free rates at 12 months 89.7% versus 87.2
Slide 29: ASPEN Topline Safety: Overall Summary
29 ASPEN Topline Safety: Overall Summary Category, n (%) Overall Ibrutinib (n = 98) Zanubrutinib (n = 101) Patients with ≥ 1 AE 97 (99.0) 98 (97.0) Grade ≥3 62 (63.3) 59 (58.4) Serious 40 (40.8) 40 (39.6) AE leading to death 4 (4.1) a 1 (1.0) b AE leading to treatment discontinuation 9 (9.2) c 4 (4.
Slide 30: ASPEN Adverse Events of Special Interest
Source: Tam et. al., ASCO 2020. Higher AE rate in bold red with ≥10% difference in any grade or ≥5% difference in grade 3 or above. No tumor lysis syndrome was reported. Opportunistic infection ibrutinib (n=2), zanubrutinib (n=1). AE, adverse event; BTKi, Bruton tyrosine kinase inhibitor; PT, prefer
Slide 31: ASPEN: Time to AE – Risk Analysis Over Duration of Treatment
31 ASPEN: Time to AE – Risk Analysis Over Duration of Treatment Source: Tam et. al., ASCO 2020. AE, adverse event. *Descriptive purpose only. Kaplan-Meier Curve: Time to Atrial Fibrillation / Flutter P value <0.05* Kaplan-Meier Curve: Time to Hypertension P value = 0.16*
Slide 32: Data Suggest Activity in Difficult to Treat WM MYD88WT Patients
32 Data Suggest Activity in Difficult to Treat WM MYD88WT Patients Sources: 1 Tam et. al. ASCO 2020, Data cut: Aug 31, 2019, Safety summary above; 2 Tam et al, EHA 2019. * Follow up for full WM cohort. ASPEN cohort 2 safety summary. The most frequently reported adverse events (AEs) were diarrhea, an
Slide 33: Zanubrutinib Efficacy in R/R MCL
33 Zanubrutinib Efficacy in R/R MCL From U.S. approved label The most common adverse reactions (> 10%) with BRUKINSA were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough,
Slide 34: Zanubrutinib Efficacy in CLL/SLL – Phase 1/2
zanubrutinib TN CLL R/R CLL Total CLL n 16 50 66 Median follow- up (mo) 7.6 14.0 10.5 Best Response ORR CR PR PR-L SD Non-evaluable* 16 (100%) 1 (6%) 13 (81%) 2 (13%) 0 0 46 (92%) 1 (2%) 41 (82%) 4 (8%) 3 (6%) 1 (2%) 62 (94%) 2 (3%) 54 (82%) 6 (9%) 3 (5%) 1 (2%) 34 Zanubrutinib Efficacy in CLL/SLL F
Slide 35: Zanubrutinib Efficacy in CLL/SLL – Phase 2
zanubrutinib Total CLL n 91 Median follow-up (mo) 15.1 Best Response ORR CR PR PR-L SD Non-evaluablea 77 (84.6%) 3 (3.3%) 54 (59.3%) 20 (22.0%) 4 (4.4%) 3 (3.3%) 35 Zanubrutinib Efficacy in CLL/SLL Frequent and durable responses – Phase 2 Source: Xu et al. 15-ICML 2019; aMissing anatomy imaging for
Slide 36: Ibrutinib Efficacy in CLL/SLL
36 Ibrutinib Efficacy in CLL/SLL Source: For TN, Burger, et al New Engl J Med 2015. For R/R, Byrd, et al New Engl J Med 2013 Progression Free Survival (Treatment-Naïve) Progression Free Survival (Relapsed / Refractory)Overall Response Rate (Relapsed / Refractory) n=136 Median FU (mo) 18.4 Best Respo
Slide 37: Ibrutinib Discontinuation for toxicity or progression in CLL/SLL
Treatment-Naïve (n=80) Relapsed/Refractory (n=536) Total (n=616) Median Follow-Up 14.5 months Total Treatment Discontinuation 19 (24%) 231 (43%) 250 (41%) Toxicity/Tolerability 12 (15%) 117 (22%) 129 (21%) CLL/SLL Progression 3 (4%) 49 (9%) 52 (8%) Transformation (RT or HD) 0 (0%) 10 (2%) 10 (2%) De
Slide 38: Zanubrutinib Discontinuation for toxicity or progression in CLL/SLL is uncommon
Treatment-Naïve (n=18) Relapsed/Refractory (n=51) Total (n=69) Median Follow-Up 10.3 months Total Treatment D/C 0 (0%) 2 (4%) 2 (3%) Toxicity/Tolerability 0 (0%) 1 (2%) 1 (1%) CLL/SLL Progression 0 (0%) 0 (0%) 0 (0%) Transformation (RT or HD) 0 (0%) 1 (2%) 1 (1%) 38 Zanubrutinib Discontinuation for
Slide 39: Zanubrutinib Safety and tolerability summary
• Very low rates of headache and hypertension (6.7% and 6.3%) • Concomitant use of anti-coagulants was allowed in these zanubrutinib trials • Low rate of treatment discontinuation for drug-related adverse events Adverse Events of Interest for BTK Inhibitors in Patients Treated with Zanubrutinib AE o
Slide 40: Zanubrutinib Responses Across Additional B-Cell Malignancies
40 Zanubrutinib Responses Across Additional B-Cell Malignancies Sources: 1. Tam et. al., ASH 2017; 2. Song et al., ICML 2019; 3. Tam et al., ICML 2019; 4. Song et. al., CSCO 2018; 5. Tedeschi et al, EHA 2020; * CT response assessment; ** PET-CT response assessment. MZL MCL MCL FL FL DLBCL Source EHA
Slide 41: Zanubrutinib Plus Obinutuzumab Combination in Follicular Lymphoma
• Overall response rate and complete responses to date compare favorably to those achieved with respective single-agents and recently approved therapies FL Zanubrutinib + Obinutuzumab Zanubrutinib Ibrutinib Obinutuzumab Idelalisib Source ICML 20191 ASH 20172 ASH 20163 JCO 20134 NEJM 20145 n 36 17 11
Slide 42: BOVen: Treatment Schema
Treatment Cycle: C1 C2 C3 C4 C5 C6 C7 C8 C9+ Venetoclax: Ramp-Up to Target 400 mg QD Zanubrutinib: 160mg BID Obinutuzumab 1000mg on /cycle 1 D1b/8/15, and Cycles 2–8 D1 PB MRD: X X X X X BM MRD: X X XC XC CT imaging: X X XC XC 42 BOVen: Treatment Schema a. Once peripheral blood (PB) uMRD is determin
Slide 43: BOVen: Achieved Rapid Undetectable MRD
43 BOVen: Achieved Rapid Undetectable MRD • Follow up: 11 months (2-14+) • Median time to uMRD in marrow: 6 months (2-14+) • 62% (23/37) met the uMRD endpoint and have stopped therapy at median 8 months (6 months of triplet) 2 months 4 months 6 months 8 months PR uMRD BM uMRD 100% 90% 80% 70% 60% 50
Slide 44: BOVen: Adverse Events of Special Interest
44 BOVen: Adverse Events of Special Interest BOVen Treatment emergent hematologic and non-hematologic adverse events occurring in ≥5% of patients - Heme: Neutropenia 51.3% (Gr 3+: 15.4%), Thrombocytopenia 46.2% (15.4%), Anemia 18%; Non-Heme: Infusion related reaction 41% (2.6%), Bruising 41%, Diarrh
Slide 45: Ongoing Global Phase Studies
45 Ongoing Global Phase 3 Studies ASPEN topline results announced in December 2019 WM=Waldenström’s macroglobulinemia, BID=twice daily, CR=complete response, MUT=mutation, PD=progressive disease, QD=once daily, R=randomization, R/R=relapsed/refractory, TN=treatment naïve, VGPR=very good partial resp
Slide 46: Ongoing Global Phase Studies in CLL/SLL: SEQUOIA and ALPINE
46 Ongoing Global Phase 3 Studies in CLL/SLL SEQUOIA and ALPINE 1L=first-line treatment, BID=twice daily, CLL=chronic lymphocytic leukemia, del=deleted, FCR=fludarabine, cyclophosphamide, and rituximab, ORR=overall response rate, PD=progressive disease, PFS=progression- free survival, QD=once daily,
Slide 47: Ongoing Pivotal Study
47 Ongoing Pivotal Study CLL/SLL=chronic lymphocytic leukemia/small lymphocytic lymphoma, FL=follicular lymphoma, ORR=overall response rate, PD=progressive disease, PFS=progression-free survival, QD=once daily, R=randomization. *Must have received prior treatment with rituximab and an alkylator; rel
Slide 48: Zanubrutinib Potentially Addresses Areas of Need for Patients Treated with BTK Inhibitors
48 Zanubrutinib Potentially Addresses Areas of Need for Patients Treated with BTK Inhibitors Efficacy • Complete and sustained target inhibition may result in better response quality – We are testing this hypothesis in Phase 3 head-to-head trials against ibrutinib in WM and CLL Tolerability • In “re
Slide 49: U.S. BRUKINSA Launch Progress
49 U.S. BRUKINSA Launch Progress BRUKINSA made commercially available within four days of November 2019 approval 1. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of cli
Slide 50: Tislelizumab Overview
tislelizumab OVERVIEW • Tislelizumab is a PD-1 checkpoint inhibitor designed to minimize binding to FcγR, which is believed to play an essential role in activating phagocytosis in macrophages to minimize its negative impact on T effector cells.1 – China label data: 77% ORR (62% CR) in R/R cHL • Broa
Slide 51: Tislelizumab Clinical Program
51 Tislelizumab Clinical Program Broad development for Asia-prevalent cancers PROGRAM (TARGET) TUMOR DOSE ESCALATION DOSE EXPANSION PIVOTAL FILED MARKET PH1a PH1b PH2* PH2** PH3 tislelizumab (PD-1) Heme R/R cHL (Approved by NMPA 12.27.19) R/R NK/T-cell lymphoma Bladder 2L+ UC (Approved by NMPA 04.10
Slide 52: Tislelizumab's Lack of FcγR Binding Was Designed to Prevent T-Cell Clearance
52 Tislelizumab’s Lack of FcγR Binding Was Designed to Prevent Macrophage-Mediated T-Cell Clearance We believe the different FcγR design may have meaningful differences in the clinic Sources: Dahan et al., Cancer Cell, 2015; Arlauckas et al., Sci. Transl. Med., 2017; FcγRI=Fc gamma receptor-1, MDSC=
Slide 53: Tislelizumab in 1L Squamous NSCLC: PFS by IRC
53 Tislelizumab in 1L Squamous NSCLC: PFS by IRC Source: Wang et. al., ESMO 2020; Abbreviations: CI, confidence interval;PFS, progression-free survival. Arm A: Tislelizumab + paclitaxel carboplatin Arm B: Tislelizumab + nabpaclitaxel carboplatin Arm C: paclitaxel carboplatin
Slide 54: Tislelizumab in 1L Squamous NSCLC: Response
54 Tislelizumab in 1L Squamous NSCLC: Response Source: Wang et. al., ASCO 2020; DCR=CR+PR+SD. *Includes patients with BOR in CR or PR or ≥24 weeks SD. Abbreviations: BOR, best overall response; CBR, clinical benefit rate; CI, confidence interval; CR, complete response; DCR, disease control rate; IRC
Slide 55: Tislelizumab in 1L Squamous NSCLC: Safety
55 Tislelizumab in 1L Squamous NSCLC: Safety Preferred Term, n (%) Arm A Tislelizumab + PC (n=120) Arm B Tislelizumab + nab-PC (n=119) Arm C PC (n=121) All Grades Grades ≥3 All Grades Grades ≥3 All Grades Grades ≥3 Anemia 99 (82.5) 6 (5.0) 104 (88.1) 24 (20.3) 87 (74.4) 11 (9.4) Alopecia 77 (64.2) 0
Slide 56: Tislelizumab in 1L Non-Squamous NSCLC: PFS by IRC
56 Tislelizumab in 1L Non-Squamous NSCLC: PFS by IRC Source: Lu et. al., ESMO 2020; Abbreviations: CI, confidence interval; IRC, Independent Review Committee; PFS, progression-free survival.
Slide 57: Tislelizumab in 1L Non-Squamous NSCLC: Best Overall Response
57 Tislelizumab in 1L Non-Squamous NSCLC: Best Overall Response Source: Lu et. al., ESMO 2020; CI, confidence interval; CR, complete response; IRC, Independent Review Committee; NE, not estimable; ORR, objective response rate; PR, partial response.
Slide 58: Tislelizumab in 1L Non-Squamous NSCLC: Safety
58 Tislelizumab in 1L Non-Squamous NSCLC: Safety Preferred Term, n (%) Arm A Tislelizumab + PP (n=222) Arm B PP (n=110) Grade 1-2 Grade ≥3 Grade 1-2 Grade ≥3 Anemia1 151 (68.0) 30 (13.5) 71 (64.5) 11 (10.0) Leukopenia2 135 (60.8) 48 (21.6) 65 (59.1) 16 (14.5) Thrombocytopenia3 112 (50.5) 43 (19.4) 5
Slide 59: Tislelizumab cHL Pivotal Trial Data
IRC Dataset cHL Enrolled Patients N=70 Median Follow-up 13.9 months Prior Lines, Median (range) 3 (2-11) ORR 87.1% CR 62.9% PR 24.3% -- Majority of transplant-ineligible patients had failed to respond to salvage chemotherapy Baseline Characteristics Total (N=70) Age (years), median (range) 32.5 (18,
Slide 60: Summary of Tislelizumab Adverse Events: cHL pivotal trial
Event, n (%) N=70 Grade ≥3 TEAE 21 (30) Serious TEAE 12* (17.1) TEAE leading to treatment discontinuation 4† (5.7) TEAE leading to death 0 (0.0) Immune-related (ir) TEAEs (by aggregate category) ≥1 irTEAE 27 (36.8) Thyroid disorder 16 (22.9) Pneumonitis 5 (7.1) Skin adverse reactions 6 (8.6) Myositi
Slide 61: Tislelizumab China UC Pivotal Trial Data
UC Enrolled Patients/evaluable N=113/104 Median Follow-up 8 months ORR 23.1% CR 7.7% PR 15.4% PFS median (95% CI) 2.1 (2.00, 2.46) OS median (95% CI) 9.8 months (7.46, 13.50) 61 Tislelizumab China UC Pivotal Trial Data Activity in previously treated patients Source: Ye et al., ESMO 2019 • IRC assess
Slide 62: Tislelizumab Response Data in Disease-Specific Cohorts
62 Tislelizumab Response Data in Disease-Specific Cohorts Sources:1. Ph1A/1B data as of 08.31.18, ESMO Immuno-Oncology 2018 Congress (Sanjeev et al); 2. Ph1 data as of 06.08.17, ESMO 2017 Congress (Horvath et al, Abstract 389P); 3. Ph1 data as of 06.08.17, ESMO 2017 Congress (Meniawy et al, Abstract
Slide 63: China Label: Summary of Adverse Reactions in Phase 2 cHL Study
63 China Label: Summary of Adverse Reactions Occurring in ≥5% of Patients in Phase 2 cHL Study1 1. Adverse reactions in this package insert are defined as: adverse events that assessed by investigator as related, definitely related, probably related, possibly related, unlikely related or missing cau
Slide 64: Tislelizumab Phase 1 Common AEs in ≥10% of Patients
64 Tislelizumab Phase 1 Common AEs in ≥ 10% of Patients Source: BGB-A317 IB v6.0; All grades, regardless of causality; Data cut-off 27 April 2018; 6 months after Last Patient Enrolled; Of the 451 total patients in the Safety Population for Study BGB A317_001, 203 (45.0%) experienced at least 1 Grade
Slide 65: Tislelizumab Chemotherapy Combination Data in Lung Cancers
65 Tislelizumab Chemotherapy Combination Data in Lung Cancers Source: Wang et. al., CSCO 2019; Sq: squamous; SCLC: small cell lung cancer. Median follow-up 15.3 months. * Median PFS data cutoff 06.30.19. Treatment-emergent adverse events (TEAEs) occurred in all 54 patients; adverse events (AEs) repo
Slide 66: Overview of Pamiparib (BGB-290)
66 Overview of Pamiparib (BGB-290) Selective Inhibitor of PARP1 and PARP2 OVERVIEW • Highly selective PARP1 and PARP2 inhibitor with potential brain penetration and strong PARP trapping activity in preclinical studies CLINICAL DATA • Ph1/2 data demonstrated pamiparib was generally well-tolerated wit
Slide 67: Pamiparib Clinical Program
67 Pamiparib Clinical Program *Some indications will not require a non-pivotal Ph2 clinical trial prior to beginning pivotal Ph2 or 3 clinical trials. **Confirmatory clinical trials post-approval are required for accelerated approvals. PROGRAM (TARGET) DOSE ESCALATION DOSE EXPANSION PIVOTAL FILED PH
Slide 68: Pamiparib Phase 1/2 in Advanced Ovarian Cancer
68 Pamiparib Phase 2 in Advanced Ovarian Cancer Patients were considered efficacy-evaluable if they had measurable disease at baseline per RECIST v1.1 and had ≥1 postbaseline tumor assessment, unless treatment had been discontinued due to clinical progression or death prior to tumor assessment. Abbr
Slide 69: Pamiparib Phase 1/2 in Advanced Ovarian Cancer: Adverse Events
69 Pamiparib Phase 2 in Advanced Ovarian Cancer Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; PA, protocol amendment; PSOC, platinum-sensitive ovarian cancer. Preferred Term, n (%) Platinum Sensitive Ovarian Cancer (n=90) Platinum Resistant Ovarian Cancer (n=23) All