Astrazeneca Plc · LSE:AZN
Astrazeneca — European Society for Medical Oncology (ESMO) Congress 2021
34 slides from Astrazeneca's conference presentation, Sep 20, 2021
Slide 1: Investor science conference call: ESMO Congress 2021
Investor science conference call: European Society for Medical Oncology (ESMO) Congress 2021 Conference call for investors and analysts 20 September 2021
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 of 1995, AstraZeneca (hereafter ‘the Group’) provides the following cautionary statement: this document contains certain forward-looking statements wit
Slide 3: Speakers
Dr Sara Hurvitz Susan Galbraith Senior Investigator, Executive Vice President, DESTINY-Breast03 and Professor Oncology R&D at David Geffen School of Medicine at UCLA Dave Fredrickson Cristian Massacesi Speakers Chief Medical Officer & Executive Vice President, Oncology Chief Development Oncology Bus
Slide 4: Agenda
1 Introduction: AstraZeneca @ ESMO 2021 Agenda 2 Enhertu (T-DXd) Phase III DESTINY-Breast03 trial 3 What’s next for Enhertu? 4 ESMO 2021 other highlights: Enhertu and Imfinzi 5 Closing and Q&A 4
Slide 5: Introduction
1 Introduction Susan Galbraith Executive Vice President, Oncology R&D
Slide 6: Comprehensive portfolio to combat cancer
Comprehensive portfolio to combat cancer Diverse pipeline with potential for orthogonal combinations Tumour drivers Oncogenic truncal drivers Redirect local immunity Immune and resistance and mechanisms of resistance Awaken dormant immune cells engagers DNA damage Synthetic lethality response exploi
Slide 7: ESMO 2021 abstracts and data highlights
ESMO 65 abstracts with Data 2021 20 oral presentations highlights • One Presidential • Enhertu in breast cancer presentation DESTINY-Breast03 • Eight Proffered paper oral • Enhertu in other cancers presentations DESTINY-Gastric02, • 11 Mini oral presentations DESTINY-Lung01 5 years of Presidential •
Slide 8: Enhertu (T-DXd) DESTINY-Breast03
2 Enhertu (T-DXd) DESTINY-Breast03 Dr Sara Hurvitz Senior Investigator, DESTINY-Breast03 Phase III trial
Slide 9: DESTINY-Breast03: first randomised phase III trial of T-DXd
DESTINY-Breast03: first randomised phase III trial of T-DXd An open-label, multicentre study (NCT03529110) Patients Primary endpoint • Unresectable or metastatic HER2-positive1 breast T-DXd • PFS (BICR) cancer 5.4 mg/kg Q3W • Previously treated with trastuzumab and taxane (n = 261) Key secondary end
Slide 10: Patient disposition
Patient disposition Screened (n = 699) Randomised (n = 524) Randomised to T-DXd (n = 261) Randomised to T-DM1 (n = 263) Treated (n = 257) Treated (n = 261) • Ongoing study treatment (n = 132) • Ongoing study treatment (n = 47) • Discontinued study treatment (n = 125) • Discontinued study treatment (
Slide 11: Efficacy: confirmed ORR and best overall response
Efficacy: confirmed ORR and best overall response 100 80 T-DXd T-DM1 60 T-DXd (n = 245)1 (n = 261) (n = 263) Best % Change in Sum of Diameters From Baseline 40 20 Confirmed ORR 0 n (%)2 208 (79.7) 90 (34.2) -20 -40 [95% CI] [74.3-84.4] [28.5-40.3] -60 -80 P < .0001 -100 CR 42 (16.1) 23 (8.7) 100 PR
Slide 12: Primary endpoint: PFS by BICR
Primary endpoint: PFS by BICR 100 T-DXd T-DM1 mPFS, mo (95% CI) NR (18.5-NE) 6.8 (5.6-8.2) Progression-Free Survival probability, % 12-mo PFS rate, % 75.8 34.1 80 (95% CI) (69.8-80.7) (27.7-40.5) 0.28 (0.22-0.37) HR (95% CI) P = 7.8 × 10-22 60 40 20 Censor T-DXd (n = 261) T-DM1 (n = 263) 0 0 1 2 3 4
Slide 13: Secondary endpoint: PFS by investigator assessment
Secondary Endpoint: PFS by investigator assessment 100 T-DXd T-DM1 mPFS, mo (95% CI) 25.1 (22.1-NE) 7.2 (6.8-8.3) Progression-Free Survival probability, % 12-mo PFS rate, % 76.3 34.9 80 (95% CI) (70.4-81.2) (28.8-41.2) 0.26 (0.20-0.35) HR (95% CI) P = 6.5 × 10-24 60 40 20 Censor T-DXd (n = 261) T-DM
Slide 14: Key secondary endpoint: overall survival
Key secondary endpoint: overall survival 100 80 Overall survival probability, % 60 40 T-DXd T-DM1 mOS, mo (95% CI) NE (NE-NE) NE (NE-NE) 20 12-mo OS rate, % (95% 94.1 85.9 CI) 90.3-96.4 80.9-89.7 Censor T-DXd (n = 261) 0.56 (0.36-0.86) HR (95% CI) T-DM1 (n = 263) P = .007172a 0 0 1 2 3 4 5 6 7 8 9 1
Slide 15: Drug-related TEAEs in ≥20% of patients
Drug-related TEAEs in ≥20% of patients System Organ Class T-DXd (n = 257) T-DM1 (n = 261) Preferred term, n (%) Any Grade Grade ≥3 Any Grade Grade ≥3 Blood and lymphatic system disorders Neutropenia1 110 (42.8) 49 (19.1) 29 (11.1) 8 (3.1) Anemia2 78 (30.4) 15 (5.8) 37 (14.2) 11 (4.2) Leukopenia3 77
Slide 16: Adverse events of special interest
Adverse events of special interest Adjudicated as drug-related ILD/pneumonitis1, n (%) n (%) Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Any Grade T-DXd (n = 257) 7 (2.7) 18 (7.0) 2 (0.8) 0 0 27 (10.5) T-DM1 (n = 261) 4 (1.5) 1 (0.4) 0 0 0 5 (1.9) • There were no grade 4 or 5 adjudicated drug-related IL
Slide 17: Conclusions
Conclusions In the first randomised Phase III trial in breast cancer, T-DXd demonstrated: Highly clinically meaningful and statistically significant improvement in PFS compared with T-DM1 in patients with HER2-positive mBC • PFS HR of 0.28 (P = 7.8×10-22) • Consistent benefit seen across key subgrou
Slide 18: T-DXd transforms the treatment paradigm
T-DXd transforms the treatment paradigm for patients with metastatic HER2+ breast cancer Trastuzumab + pertuzumab + taxane, 1L CLEOPATRA1 : mPFS = 18.7 months T-DM1 + pertuzumab, Second-line monotherapy data 1L MARIANNE2: mPFS = 15.2 months that rivals first-line current standard triplet therapy T-D
Slide 19: What's next for Enhertu?
3 What’s next for Enhertu? Dave Fredrickson Executive Vice President, Oncology Business Unit
Slide 20: Enhertu: a new standard of care
Enhertu: a new standard of care for patients with HER2-positive metastatic breast cancer Today: 3rd-line+ mBC 2022: 2nd-line mBC Future: earlier settings, combinations • Strong launch trajectory: • DESTINY-Breast03: market leader in every unprecedented benefit in • Efficacy and safety profile major
Slide 21: Enhertu in breast cancer and beyond
Enhertu in breast cancer and beyond Opportunities across treatment settings neo-adjuvant / adjuvant 1st-line metastatic 2nd-line metastatic 3rd-line metastatic neo-adjuvant post neo-adjuvant adjuvant replace replace replace chemo + T-DM1 chemo + replace HER2-positive trastuzumab + trastuzumab + repl
Slide 22: Other ESMO 2021 highlights - Enhertu and Imfinzi
4 Other ESMO 2021 highlights - Enhertu and Imfinzi Susan Galbraith Executive Vice President, Oncology R&D
Slide 23: Enhertu: extending clinical benefit to other cancers
Enhertu: extending clinical benefit to other cancers Phase II DESTINY-Lung01 Phase II DESTINY-Gastric02 Robust and durable anti-cancer activity in patients with Efficacy results demonstrate clinically meaningful previously treated HER2m NSCLC and durable responses Overall Survival Best Percentage Ch
Slide 24: Enhertu: an extensive clinical development programme
Enhertu: an extensive clinical development programme Focusing on HER2+ and HER2-low breast cancer and other cancers Post-neoadjuvant/ 1st line 2nd line 3rd line+ Adjuvant DESTINY-Breast05 Ph III DESTINY-Breast07 Ph Ib/II (Part 2) DESTINY-Breast03 Ph III DESTINY-Breast01 Ph II Breast cancer HER2+ DES
Slide 25: Imfinzi in Stage III, unresectable non-small cell lung cancer
Imfinzi in Stage III, unresectable non-small cell lung cancer Cementing leadership in this potentially curative setting PACIFIC-R: Real world PFS COAST: PFS by investigator’s analysis Imfinzi after CRT for a median duration of ~11 months is effective in a First randomised Phase II to show evidence o
Slide 26: Imfinzi: extending IO leadership through portfolio combinations
Imfinzi: extending IO leadership through portfolio combinations ADCs CD73, NKG2A PARP inhibitor POC: BEGONIA mBC 1L HER2-low/HR- POC: COAST – Stg III UR NSCLC (below) / Study 5 (PDAC) POC: MEDIOLA BRCAwt PSR ovarian (below) / BAYOU (UC) 1.0 0.9 Lynparza + Imfinzi + bevacizumab 0.8 72.7% 0.7 PFS prob
Slide 27: Closing and Q&A
5 Closing and Q&A
Slide 28: Investor Relations
Chris Sheldon Josie Afolabi chris.sheldon@astrazeneca.com josie.afolabi@astrazeneca.com Tom Waldron Morgan Sanford Investor tom.waldron@astrazeneca.com morgan.sanford@astrazeneca.com Relations Christer Gruvris Philip Sparks christer.gruvris@astrazeneca.com philip.sparks1@astrazeneca.com Lauren Swale
Slide 29: Appendix
A Appendix
Slide 30: Enhertu: DESTINY-Lung01 trial design
Enhertu: DESTINY-Lung01 trial design Multi-centre, international, 2-cohort Phase II trial (NCT03505710) Key eligibility criteria Primary end point Cohort 1: HER2-overexpressing3 Cohort 1a: HER2-overexpressing3 • Confirmed ORR by ICR4 • Unresectable/metastatic (IHC 3+ or IHC 2+) (IHC 3+ or IHC 2+) no
Slide 31: Enhertu: DESTINY-Gastric02 trial design
Enhertu: DESTINY-Gastric02 trial design Open-label, multicentre Phase II trial in Western patients with HER2+ gastric or GEJ cancer (NCT04014075) Key eligibility criteria Primary endpoint • Confirmed ORR by ICR • Pathologically documented, unresectable or metastatic gastric or GEJ cancer T-DXd Secon
Slide 32: Imfinzi: COAST trial design
Imfinzi: COAST trial design A Phase II, randomised open-label trial Study treatment up to 12 months CONTROL Durvalumab 1500 mg IV Primary Endpoint Locally advanced, monotherapy Q4W • ORR by investigator unresectable, Stage assessment (RECIST v1.1) 1–42 days III NSCLC post-cCRT Secondary Endpoints AR
Slide 33: Imfinzi: Propensity score matching of COAST with PACIFIC
Imfinzi: Propensity score matching of COAST (durvalumab arm) with PACIFIC (durvalumab arm) • Matching variables: Age (<75, ≥75), Race (Asian, Other), Prior therapy (Carboplatin, Cisplatin), Time from last radiation to randomisation (<14 days, ≥14 days), Best response to prior therapies (PR, SD) and
Slide 34: Use of AstraZeneca slides from conference calls and webcasts
Use of AstraZeneca slides from conference calls and webcasts 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 available to th
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