Astrazeneca Plc · LSE:AZN
Astrazeneca — Investor Day (June 2024)
59 slides from Astrazeneca's investor day presentation, Jun 3, 2024
Slide 1: ASCO 2024 Investor event
ASCO 2024 Investor event 03 June 2024
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: AstraZeneca @ ASCO 2024 Agenda
AstraZeneca @ ASCO 2024 Agenda CEO opening remarks – Pascal Soriot, CEO AstraZeneca presence at ASCO 2024 – Susan Galbraith, EVP, Oncology R&D Clinical Impressions Lung – Leora Horn, Late Clinical Development and Global Clinical Strategy Lead, Lung Cancer, R&D (moderator) Dr Charu Aggarwal, Universi
Slide 4: Speakers and panelists
AstraZeneca @ ASCO 2024 Speakers and panelists ASTRAZENECA LEADERSHIP KEY EXTERNAL EXPERTS Dave Fredrickson Dr Charu Aggarwal Pascal Soriot EXECUTIVE VICE PRESIDENT, THORACIC MEDICAL ONCOLOGIST, CHIEF EXECUTIVE OFFICER UNIVERSITY OF PENNSYLVANIA ONCOLOGY BUSINESS SCHOOL OF MEDICINE Leora Horn Dr Reb
Slide 5: Furthering our oncology ambition at ASCO 2024
Furthering our oncology ambition at ASCO 2024 Pascal Soriot CHIEF EXECUTIVE OFFICER 5
Slide 6: Ambition – $80bn Total Revenue by 2030 & sustained 2030+ growth
Ambition – $80bn Total Revenue by 2030 & sustained 2030+ growth Working on “today, tomorrow and the day after" Beyond 2030 Illustrative only, not to scale ADCs and Radioconjugates Cell therapy and T-cell engagers Launching key NMEs $80bn Gene therapy AZD0120 rilvegostomig AZD0486 saruparib Next-gene
Slide 7: Investing in disruptive categories to drive 2030+ growth
Investing in disruptive categories to drive 2030+ growth Weight management ADCs and Cell therapy and Gene therapy and Next-gen IO bispecifics and risk factors Radioconjugates T-cell engagers gene editing Establish and Develop scalable cell Replace systemic Make cure possible lead in new Replace exis
Slide 8: AstraZeneca – six years in a row of plenary presentations
AstraZeneca – six years in a row of plenary presentations POLO ADAURA OlympiA DB04 ADAURA OS ADRIATIC LAURA ASCO 2024 | DESTINY-Breast06 granted special oral LBA session 8 Collaboration partners: Daiichi Sankyo (Enhertu), Merck & Co., Inc. (Lynparza).
Slide 9: Significant news flow across key medicines through 2025
Significant news flow across key medicines through 2025 2024 2025 Imfinzi Tagrisso Enhertu Dato-DXd Dato-DXd + Imfinzi Imfinzi + ceralasertib ADRIATIC LAURA DESTINY-Breast06 TROPION-Breast01 AVANZAR LATIFY ASCO plenary (June 2024) ASCO plenary (June’24) ASCO LBA (June 2024) regulatory decision 1L NS
Slide 10: AstraZeneca presence at ASCO 2024
AstraZeneca presence at ASCO 2024 Susan Galbraith EVP, HEAD OF ONCOLOGY R&D 10
Slide 11: Key data highlights
Key data highlights 119 abstracts accepted • LAURA (Plenary LBA4) • ADRIATIC (Plenary LBA5) 73 poster presentations • DESTINY-Breast06 (LBA1000) 16 oral presentations • AZD70031 Phase I (4019) 2 Plenary presentations • TROPION-Lung02 additional follow-up (8617) 1 special LBA session • I-SPY 2.2 (LBA
Slide 12: Key ASCO 2024 data furthers our ambition to become the leading Oncology company by 2030
Key ASCO 2024 data furthers our ambition to become the leading Oncology company by 2030 LAURA DESTINY-Breast06 Strengthening tumour Tagrisso Stg III u/r EGFRm NSCLC Enhertu 2L HR+, HER2-low and -ultralow area leadership ADRIATIC TROPION-Breast01 BREAST • LUNG Imfinzi post-CRT LS-SCLC Dato-DXd in HR+
Slide 13: Our R&D strategy to transform patient outcomes
Our R&D strategy to transform patient outcomes Attack cancer from Lead with Treat earlier and smarter multiple angles innovative technology Treatment journey today Data and AI in clinical trials HER2 Accelerating computational TROP2 pathology Future treatment journey Improving patient outcomes throu
Slide 14: Phase I/II efficacy data reinforce Dato-DXd + IO potential in Phase III combination trials
Phase I/II efficacy data reinforce Dato-DXd + IO potential in Phase III combination trials Strong efficacy demonstrated across doublet and Strong and consistent efficacy triplet combinations in NSCLC observed in breast cancer % ORR % ORR TROPION- Dato-DXd + pembro 56% (n=30/54) BEGONIA3 Lung021 TROP
Slide 15: TROPION-Lung02 – Updated data support ongoing Phase III trials of Dato-DXd + IO ± CTx in 1L setting
TROPION-Lung02 – Updated data support ongoing Phase III trials of Dato-DXd + IO ± CTx in 1L setting Durable clinical response for Encouraging PFS for doublet and triplet both doublet and triplet independent of PD-L1 status ORR 52% doublet 100 mPFS 11.1 mo doublet 56% triplet 80 6.8 mo triplet 60 PFS
Slide 16: I-SPY 2 – First IO + ADC combination showing strong pCR rates
I-SPY 2 – First IO + ADC combination showing strong pCR rates in HR+ and HR- patients with breast cancer A B C • Phase II trial in neoadjuvant breast cancer • Strong efficacy in neoadjuvant, Immune+ breast cancer with only 4 cycles of Dato-DXd + Imfinzi • ~30% patients went to surgery at end of Bloc
Slide 17: AZD7003 – GPC3-specific TGFβRIIDN armoured CAR-T
AZD7003 – GPC3-specific TGFβRIIDN armoured CAR-T First clinical data in liver cancer, highlights potential of CAR-T in solid tumours Differentiated vs other GPC3 CAR-Ts FIH data from Phase I, open-label, dose escalation Only clinical-stage CAR-T armoured with TGFβRIIDN and expansion study conducted
Slide 18: AZD7003 – Encouraging early efficacy in heavily pre-treated HCC patients
AZD7003 – Encouraging early efficacy in heavily pre- treated HCC patients with ORR 56.6% across dose levels Robust cellular expansion and Encouraging tumour responses with mDoR of 7.36 persistence in patients months after median follow-up of 9.03 months 106 DL 1 DL 2 DL 3 105 DL 4 Best tumour shrink
Slide 19: Clinical impressions Lung cancer
Clinical impressions Lung cancer Physician fireside Leora Horn Charu Aggarwal Global Clinical Head for Lung Thoracic Medical Oncologist, Cancer and Lung Cancer Strategy, University of Pennsylvania School AstraZeneca of Medicine
Slide 20: ADRIATIC
ADRIATIC Randomised, double-blind, placebo-controlled, multi-centre global Phase III trial evaluating Imfinzi monotherapy and Imfinzi plus Imjudo vs placebo in limited stage SCLC 20
Slide 21: ADRIATIC Phase III first potential major advancement in systemic treatment for LS-SCLC
ADRIATIC Phase III first potential major advancement in systemic treatment for LS-SCLC for several decades High unmet need in SCLC ADRIATIC Phase III addresses limited stage-SCLC Stage I–III >2.4 million LS-SCLC (stage I/II No progression following cCRT new lung cancer cases inoperable) per year, gl
Slide 22: Imfinzi first and only immunotherapy to show survival benefit in limited-stage SCLC
Imfinzi first and only immunotherapy to show survival benefit in limited-stage SCLC in global Phase III trial ~57% of patients treated with ~46% of patients treated with Imfinzi had not Imfinzi alive at three years experienced disease progression at two years 1.0 OS HR 0.73 (CI 0.57-0.93, p=0.0104)
Slide 23: Safety profile for Imfinzi generally manageable and consistent with known profile
Safety profile for Imfinzi generally manageable and consistent with known profile Common AEs4 consistent with Similar rate of Grade ≥3 AEs between arms previous trials of Imfinzi Imfinzi Placebo AEs, n (%) (n=263) (n=265) All grade 247 (94.3) 234 (88.3) Grade ≥3 64 (24.4) 64 (24.2) 78 (29.8) 64 (24.
Slide 24: LAURA
LAURA Randomised, double-blind, placebo-controlled, multi-centre, global Phase III trial evaluating Tagrisso vs placebo in patients with unresectable, Stage III EGFRm NSCLC whose disease has not progressed following definitive platinum-based CRT 24
Slide 25: LAURA Phase III opportunity to bring Tagrisso to population with poorer outcomes
LAURA Phase III opportunity to bring Tagrisso to population with poorer outcomes on current SoC LAURA Phase III addresses Unmet need in unresectable Stage III EGFRm NSCLC Stage III unresectable setting PACIFIC EGFRm post-hoc subgroup analysis1 Locally advanced, No progression PFS HR 0.91 (CI 0.39-2.
Slide 26: Tagrisso demonstrated overwhelming efficacy benefit in LAURA Phase III trial
Tagrisso demonstrated overwhelming efficacy benefit in LAURA Phase III trial Statistically significant and clinically meaningful Early trend to OS benefit with Tagrisso vs placebo improvement in PFS with Tagrisso vs placebo 1.0 PFS HR 0.16 (CI 0.10-0.24, p<0.001) 1.0 0.9 mPFS 39.1 vs 5.6 months 0.9
Slide 27: Safety profile of Tagrisso post-CRT was as expected and manageable
Safety profile of Tagrisso post-CRT was as expected and manageable Low discontinuation rate for Tagrisso Consistent AE profile with previous Tagrisso trials Radiation pneumonitis 48 2 38 Tagrisso Placebo Diarrhoea 36 2 14 (n=143) (n=73) Rash 24 14 COVID-1 9 20 1 8 Any AE 140 (98) 64 (88) Paronychia
Slide 28: Clinical impressions Breast cancer
Clinical impressions Breast cancer Physician fireside Ingrid Mayer Rebecca Dent Head of the Department of Medical Global Clinical Strategy Head, Oncology and Chief of the Breast Breast and Gynaecological Cancers Medical Oncology Service at the AstraZeneca National Cancer Center Singapore 28
Slide 29: DESTINY-Breast06
DESTINY-Breast06 Randomised, open-label, Phase III trial in patients with HR-positive, HER2- low or HER2-ultralow advanced or metastatic breast cancer evaluating Enhertu vs investigator’s choice of chemotherapy 29
Slide 30: Enhertu demonstrated efficacy in HER2-low mBC in an earlier line of treatment
Enhertu demonstrated efficacy in HER2-low mBC in an earlier line of treatment to DESTINY-Breast04 % of HR+, HER2-negative mBC • Enhertu demonstrated efficacy in HER2-low mBC in an earlier line of treatment to DESTINY-Breast04 • Including HER2-ultralow, the proportion of ~20-25% patients who could be
Slide 31: Statistically significant and clinically meaningful PFS improvement with Enhertu vs TPC
Statistically significant and clinically meaningful PFS improvement with Enhertu vs TPC in HER2-low and ITT HER2-low PFS ITT PFS (HER2-low + HER2-ultralow) 1.0 PFS HR 0.62 1.0 PFS HR 0.63 1 (CI 0.51-0.74, p<0.0001 ) (CI 0.53-0.75, p<0.00012) 0.8 0.8 mPFS 13.2 vs 8.1 months mPFS 13.2 vs 8.1 months 0.
Slide 32: Clinically meaningful PFS improvement with Enhertu consistent between HER2-low and -ultralow
Clinically meaningful PFS improvement with Enhertu vs TPC consistent between HER2-low and -ultralow disease HER2-ultralow PFS (BICR) (N=152) HER2-ultralow OS1 (N=152) 1.0 PFS HR 0.78 1.0 (CI 0.50-1.21) OS HR 0.75 84.0% (CI 0.43-1.29) 0.8 0.8 mPFS 13.2 vs 8.3 Probability of PFS 78.7% Probability of O
Slide 33: Strengthening our leadership in lung and breast
Strengthening our leadership in lung and breast Dave Fredrickson EVP, HEAD OF ONCOLOGY 33
Slide 34: Our commercial strategy to transform cancer outcomes
Our commercial strategy to transform cancer outcomes Medicines that matter Leveraging scale Transforming patient care Building transformative brands Tumour area leadership Closing the care gap Lung Haematology Precision / Early detection diagnostics GYN/GU Breast Guideline-based Patient Gastrointest
Slide 35: Key data furthers ambition to redefine treatment of lung cancer
AstraZeneca @ ASCO 2024 Key data furthers ambition to redefine treatment of lung cancer Early Metastatic Dato-DXd to replace chemotherapy I. Replace systemic chemotherapy with Imfinzi ADCs established as SoC TROPION-Lung02 Phase I/II IO sensitive — TROPION-Lung02 updated data cut reinforce confidenc
Slide 36: LAURA – Tagrisso expanding presence in early-stage, potential SoC
LAURA – Tagrisso expanding presence in early-stage, potential SoC Stg. III unresectable EGFRm NSCLC • Significant unmet need in EGFRm patients — CRT alone has increased risk of distant recurrence Stage III unresectable NSCLC | 97k G7 — IO post-CRT limited additional benefit in EGFRm EGFRm | ~14% EGF
Slide 37: ADRIATIC – Imfinzi first-and-only IO in LS-SCLC
ADRIATIC – Imfinzi first-and-only IO in LS-SCLC and first novel innovation in over three decades cCRT is SoC, survival outcomes remain poor >2.4 million ~14% 1/3 50% thoracic recurrence at 2 years 3 new lung cancer cases of cases are diagnosed diagnosed globally1 SCLC2 with LS-SCLC2 19% CNS recurren
Slide 38: Key data furthers ambition to redefine treatment of breast cancer
AstraZeneca @ ASCO 2024 Key data furthers ambition to redefine treatment of breast cancer Early Metastatic I. Address full spectrum of HR+ disease through targeted Enhertu backbone for HER2+ disease medicines and novel combinations HER2+ DB03 OS | DB07 • ER drive exists – deliver best-in-class ET, s
Slide 39: DESTINY-Breast06 – Enhertu moving into 2L and expanding into HER2-ultralow
DESTINY-Breast06 – Enhertu moving into 2L and expanding into HER2-ultralow breast cancer HER2 IHC 0 HER2-ultralow HER2-low HER2-low Enhertu expands into ~60-65% chemotherapy-naïve population, following 1-2 lines endocrine therapy IHC 0 IHC >0 <1+ IHC 1+ IHC 2+ ~20k receptors 20-100k receptors ~100-2
Slide 40: Q&A session
Q&A session ASTRAZENECA LEADERSHIP KEY EXTERNAL EXPERTS Pascal Soriot Susan Galbraith Dr Charu Aggarwal MEDIC AL O N C O L O GIS T , C EO , AS T RAZEN EC A EVP, O N C O L O GY R& D L UN G C AN C ER Cristian Massacesi Dr Rebecca Dent Dave Fredrickson C H IEF MEDIC AL O F F IC ER MEDIC AL O N C O L O
Slide 41: Appendix
Appendix Lung and breast tumour maps 41
Slide 42: AstraZeneca in lung cancer
A P P E N D I X | Oncology tumour maps AstraZeneca in lung cancer Ambition for >50% of lung cancer patients to be eligible for AZN medicine by 2030 resectable unresectable metastatic Stg. I-III Stg. I-II Stg. III 1L 2L+ Leading the future of Est. epi (G7) ~200K ~30K ~70K ~350K ~290K lung cancer trea
Slide 43: AstraZeneca in breast cancer
A P P E N D I X | Oncology tumour maps AstraZeneca in breast cancer Ambition to eliminate breast cancer as a cause of death established SoC Early Metastatic Neoadjuvant Adjuvant 1st line 2nd line 3rd line 4th line + Est. epi (G7) 540k 125k 90k 65k 55k Enhertu ± THP NSTà residual disease à HER2-posit
Slide 44: Appendix
Appendix Key data at ASCO 2024 44
Slide 45: TROPION-Breast01
TROPION-Breast01 Randomised, open-label, Phase III trial evaluating Enhertu vs T-DM1 in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane 45
Slide 46: PRO data support Dato-DXd as a potential new, well-tolerated therapeutic option
PRO data support Dato-DXd as a potential new, well-tolerated therapeutic option for HR+ HER2- adv. BC Time to deterioration1 in GHS/QoL (first instance) Time to deterioration1 in GHS/QoL (confirmed) TTD HR 0.85 (CI 0.68-1.06) TTD HR 0.76 (CI 0.58-0.98) 1.0 1.0 mTTD (first instance) 3.4 vs 2.1 months
Slide 47: DESTINY-Breast06
DESTINY-Breast06 Randomised, open-label, Phase III trial in patients with HR-positive, HER2- low or HER2-ultralow advanced or metastatic breast cancer evaluating Enhertu vs investigator’s choice of chemotherapy 47
Slide 48: Enhertu demonstrated efficacy in HER2-low mBC in an earlier line of treatment
Enhertu demonstrated efficacy in HER2-low mBC in an earlier line of treatment to DESTINY-Breast04 % of HR+, HER2-negative mBC • Enhertu demonstrated efficacy in HER2-low mBC in an earlier line of treatment to DESTINY-Breast04 • Including HER2-ultralow, the proportion of ~20-25% patients who could be
Slide 49: Statistically significant and clinically meaningful PFS improvement with Enhertu vs TPC
Statistically significant and clinically meaningful PFS improvement with Enhertu vs TPC in HER2-low and ITT HER2-low PFS ITT PFS (HER2-low + HER2-ultralow) 1.0 PFS HR 0.62 1.0 PFS HR 0.63 1 (CI 0.51-0.74, p<0.0001 ) (CI 0.53-0.75, p<0.00012) 0.8 0.8 mPFS 13.2 vs 8.1 months mPFS 13.2 vs 8.1 months 0.
Slide 50: Clinically meaningful PFS improvement with Enhertu consistent between HER2-low and -ultralow
Clinically meaningful PFS improvement with Enhertu vs TPC consistent between HER2-low and -ultralow disease HER2-ultralow PFS (BICR) (N=152) HER2-ultralow OS1 (N=152) 1.0 PFS HR 0.78 1.0 (CI 0.50-1.21) OS HR 0.75 84.0% (CI 0.43-1.29) 0.8 0.8 mPFS 13.2 vs 8.3 Probability of PFS 78.7% Probability of O
Slide 51: Trend to overall survival benefit with Enhertu vs TPC
Trend to overall survival benefit with Enhertu vs TPC (~40% maturity) HER2-low OS1 (N=713) ITT OS (HER2-low + HER2-ultralow) (N=866) 1.0 OS HR 0.83 1.0 OS HR 0.81 87.6% (CI 0.66-1.05, p=0.11812) (CI 0.65-1.003) 87.0% 40% data maturity 0.8 0.8 81.7% 81.1% Probability of OS Probability of OS 0.6 0.6 0
Slide 52: Enhertu safety profile consistent with known profile
Enhertu safety profile consistent with known profile Enhertu AE profile generally manageable Common AEs consistent with through dose interruptions and reductions previous trials of Enhertu Enhertu TPC TEAEs, n (%) (n=434) (n=417) Any TEAE 438.5 263.5 429 (98.8) 397 (95.2) Treatment-related TEAEs 417
Slide 53: DESTINY-Breast03
DESTINY-Breast03 Randomised, open-label, Phase III trial evaluating Enhertu vs T-DM1 in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane 53
Slide 54: Long-term follow-up from DESTINY-Breast03 further support superiority of Enhertu
Long-term follow-up from DESTINY-Breast03 further support superiority of Enhertu over T-DM1 2L+ HER2+ mBC Investigator-assessed mPFS Over 4 years median overall ~4 times longer for Enhertu vs T-DM1 survival for patients on Enhertu 100 100 PFS HR 0.30 (CI 0.24-0.38) OS HR 0.73 (CI 0.56-0.94) mPFS 29.
Slide 55: DESTINY-Breast07
DESTINY-Breast07 Open-label, Phase Ib/II trial in patients with HER2-positive advanced or metastatic breast cancer evaluating Enhertu 55
Slide 56: DESTINY-Breast07 – first dataset of Enhertu ± pertuzumab as 1L treatment
DESTINY-Breast07 – first dataset of Enhertu ± pertuzumab as 1L treatment for HER2+ mBC Improved PFS rate at 12 months, Robust efficacy demonstrated by ORR and mDOR1 further follow-up required2 1.0 89.4% 0.8 Probability of PFS 80.8% 0.6 0.4 0.2 ■ Enhertu monotherapy ■ Enhertu + pertuzumab 0 0 3 6 9 1
Slide 57: AZD0901
AZD0901 Multi-centre, open-label Phase I trial evaluating AZD0901 in relapsed and/or refractory advanced solid tumours 57
Slide 58: AZD0901 – Promising clinical efficacy in pretreated CLDN18.2-high gastric/GEJ cancer
AZD09011 – Promising clinical efficacy in pretreated patients with CLDN18.2-high gastric/GEJ cancer Encouraging mPFS of 4.8 months and Robust ORR of 48% in 2.2 mg/kg cohort mOS of 11.8 months in 2.2 mg/kg cohort 60 PD 40 PD PD D P Maximum decrease from baseline 20 20% PD P in sum of longest diameter
Slide 59: Glossary
Glossary 1L, 2L, 3L first-, second-, third-line ET endocrine therapy oGLP-1 oral glucagon-like receptor peptide-1 4-IBB tumour necrosis factor ligand superfamily member 9 exp. expressing ORR overall response rate AAV adeno-associated virus FDC fixed dose combination OS overall survival AC doxorubici