Astrazeneca Plc · LSE:AZN
Astrazeneca — American Society of Hematology (ASH) Annual Meeting & Exposition 2019
27 slides from Astrazeneca's conference presentation, Dec 10, 2019
Slide 1: American Society of Hematology (ASH) Annual Meeting & Exposition 2019
American Society of Hematology (ASH) Annual Meeting & Exposition 2019 Conference call for investors and analysts 10 December 2019
Slide 2: Forward-looking statements
Forward-looking statements In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act 1995, we are providing the following cautionary statement: This document contains certain forward‐looking statements with respect to the operations, pe
Slide 3: Agenda
Agenda Introduction Calquence Phase III ELEVATE TN trial Haematology update Q&A 3
Slide 4: 2019: a successful year for the pipeline
2019: a successful year for the pipeline Investor science events in each therapy area Oncology Cardiovascular, renal Respiratory and metabolism (and immunology) American Society of European Society of American College of Clinical Oncology (Jun) Cardiology (Sep) Rheumatology (Nov) • Meet AZN manageme
Slide 5: 2019 ASH: strong, increasing presence
2019 ASH: strong, increasing presence 54% increase in ASH Key abstracts abstracts 2018 to 2019 at ASH 2019 2019 2018 Oral presentations Posters ELEVATE TN Monotherapy (CL‐007) CLL (CL‐001) update 8 7 Calquence/ven RWE w/Calquence /obin untx CLL in MCL and CLL 22 7 RWE novel agents Clinician/patient
Slide 6: Presenters
Presenters Dr. John Byrd Primary investigator, Phase III ELEVATE TN trial Susan Galbraith Senior Vice President, Head of Early Oncology 6
Slide 7: Agenda
Agenda Introduction Calquence Phase III ELEVATE TN trial Haematology update Q&A 7
Slide 8: Calquence Phase III ELEVATE TN trial: Background
Calquence Phase III ELEVATE TN trial Background Sharman, ASH 2019 Background • The treatment of symptomatic CLL has changed dramatically with the introduction of the Bruton tyrosine kinase inhibitor (BTKi) ibrutinib • Prior to ibrutinib introduction, obinutuzumab (G) plus chlorambucil (Clb) was a st
Slide 9: Trial design
Calquence Phase III ELEVATE TN trial Trial design Sharman, ASH 2019 ELEVATE TN Study Design (ACE-CL-007) Treatment-naive CLL Acalabrutiniba + Obinutuzumab (G)b Primary endpoint a100 mg PO BID (N=535) b1000 mg IV on D1, 2, 8, and 15 of Cycle 2, + D1 of • PFS (assessed by IRC) Acala-G R vs G-Clb Age ≥
Slide 10: Patient demographics
Calquence Phase III ELEVATE TN trial Patient demographics Sharman, ASH 2019 Patient Demographics and Baseline Characteristics Acala-G Acalabrutinib G-Clb Characteristic N=179 N=179 N=177 Age, median (range), years 70.0 (41.0-88.0) 70.0 (44.0-87.0) 71.0 (46.0-91.0) ≥65 years, n (%) 144 (80.4) 151 (84
Slide 11: PFS (primary endpoint)
Calquence Phase III ELEVATE TN trial PFS (primary endpoint) Sharman, ASH 2019 IRC-Assessed Progression-Free Survival Median follow-up 28.3 months 100 93% Progression-free survival (%) 80 87% Hazard ratio (95% CI) Acala-G 0.10 (0.06, 0.17) 60 vs G-Clb p<0.0001 47% Acalabrutinib 0.20 (0.13, 0.30) vs G
Slide 12: PFS by subgroup
Calquence Phase III ELEVATE TN trial PFS by subgroup, 1 Sharman, ASH 2019 IRC-Assessed PFS Benefit Consistent Across Subgroups Favor Acala-G Favor G-Clb or acalabrutinib 12
Slide 13: PFS by subgroup
Calquence Phase III ELEVATE TN trial PFS by subgroup, 2 Sharman, ASH 2019 IRC-Assessed PFS Benefit Consistent Across Subgroups a a Prespecified subgroup definition for bulky disease (5 cm) was different than what is presented (10 cm). Favor Acala-G Favor G-Clb or acalabrutinib NE, not estimable 13
Slide 14: Overall response rate
Calquence Phase III ELEVATE TN trial Overall response rate Sharman, ASH 2019 IRC-Assessed Response Rates p<0.0001 ORR n=168 p=0.0763 93.9% (95% CI 89.3, 96.5) 100 ORR n=153 ORR n=139 90 23 85.5% (95% CI 79.6, 89.9) 78.5% (95% CI 71.9, 83.9) (13%) 1 80 1 (1%) (1%) 8 Response (%) 70 (5%) 60 Complete r
Slide 15: Overall survival
Calquence Phase III ELEVATE TN trial Overall survival Sharman, ASH 2019 Overall Survival (Median follow-up 28.3 months) 100 Deaths N (%) Acala-G 9 (5.0) 80 Acala 11 (6.1) Overall survival (%) G-Clb 17 (9.6) 60 Hazard ratio (95% CI) Acala-G 0.47 (0.21, 1.06) 40 vs G-Clb p=0.0577 Acalabrutinib 0.60 (0
Slide 16: Safety overview
Calquence Phase III ELEVATE TN trial Safety overview Sharman, ASH 2019 Safety Overview Acala-G Acalabrutinib G-Clb AE type, n (%) N=178 N=179 N=169 Patients with ≥1 AE (all grades) 171 (96.1) 170 (95.0) 167 (98.8) Serious AEs 69 (38.8) 57 (31.8) 37 (21.9) Grade ≥3 125 (70.2) 89 (49.7) 118 (69.8) Gra
Slide 17: Most common adverse events
Calquence Phase III ELEVATE TN trial Adverse events, most common (≥15% patients) Sharman, ASH 2019 Most Common AEs (≥15% Patients) in Any Treatment Arm Acala-G Acalabrutinb G-Clb N=178 N=179 N=169 AEs, n (%) Any Grade ≥3 Any Grade ≥3 Any Grade ≥3 Headache 71 (39.9) 2 (1.1) 66 (36.9) 2 (1.1) 20 (11.8
Slide 18: Most common serious adverse events
Calquence Phase III ELEVATE TN trial Adverse events, serious Sharman, ASH 2019 Most Common Serious AEs Acala-G Acalabrutinib G-Clb SAEs (≥2% patients), n (%) N=178 N=179 N=169 Any 69 (38.8) 57 (31.8) 37 (21.9) Pneumonia 12 (6.7) 5 (2.8) 3 (1.8) IRR 4 (2.2) 0 2 (1.2) Anemia 3 (1.7) 4 (2.2) 0 Febrile
Slide 19: Events of clinical interest for acalabrutinib
Calquence Phase III ELEVATE TN trial Adverse events, clinical interest Sharman, ASH 2019 Events of Clinical Interest for Acalabrutinib Acala-G Acalabrutinib G-Clb AEs, n (%) N=178 N=179 N=169 Any Grade ≥3 Any Grade ≥3 Any Grade ≥3 Atrial fibrillation 6 (3.4) 1 (0.6) 7 (3.9) 0 1 (0.6) 0 Hypertension
Slide 20: Conclusions
Calquence Phase III ELEVATE TN trial Conclusions Sharman, ASH 2019 Conclusions • In the ELEVATE TN study: – acalabrutinib + G and acalabrutinib monotherapy both significantly improved progression-free survival vs chemoimmunotherapy (G + Clb), with a tolerable safety profile in patients with TN CLL –
Slide 21: Agenda
Agenda Introduction Calquence Phase III ELEVATE TN trial Haematology update Q&A 21
Slide 22: Haematology: Calquence
Haematology: Calquence Phase III data readouts in CLL provide momentum Key data readouts and milestones $173m Trial/milestone Phase Status worldwide Calquence sales since launch in November 2017 ACE-CL-309 ASCEND in III Approved (US) relapsed/refractory CLL 17,000 ACE-CL-007 ELEVATE TN in previously
Slide 23: Haematology: Calquence US prescribing information key aspects
Haematology: Calquence US prescribing information key aspects Indication Warnings and and usage precautions Adverse events Rate of occurrence Calquence is indicated for the treatment of adult patients with: Serious and opportunistic infections Grade 3 or higher 19% • MCL who have received at least o
Slide 24: Haematology: 'What's next?'
Haematology: ‘What’s next?’ Building on Calquence foundation, as CLL emerges Calquence EHA presentation and ‘What’s in CLL • front‐line high‐level results next?’ • ASCEND ASCEND PFS hazard ratio 0.31 • AZD5991 (MCL1 inhibitor): novel Met Phase III primary endpoint in macrocyclic chemistry relapsed/r
Slide 25: Agenda
Agenda Introduction Calquence Phase III ELEVATE TN trial Haematology update Q&A 25
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Slide 27: Use of AstraZeneca conference call, webcast and presentation slides
Use of AstraZeneca conference call, webcast and presentation slides The AstraZeneca webcast, conference call and presentation slides (together the ‘AstraZeneca Materials’) are for your personal, non‐commercial use only. You may not copy, reproduce, republish, post, broadcast, transmit, make availabl
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