Slide 1: ASCO 2023 Meet AZN Management
ASCO 2023 Meet AZN Management For investors and analysts 05 June 2023
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 2023 Agenda
AstraZeneca @ ASCO 2023 AGENDA | Furthering our oncology ambition @ ASCO 2023 – Pascal Soriot, CEO Susan Galbraith, EVP, Oncology R&D Strengthening our presence in lung cancer – Dave Fredrickson, EVP, Oncology Business & advancing emerging portfolio Dr Roy Herbst, Deputy Director, Yale Cancer Center
Slide 4: Speakers and panelists
AstraZeneca @ ASCO 2023 Speakers and panelists THERAPEUTIC AREA LEADERSHIP KEY EXTERNAL EXPERT Dave Fredrickson, Leora Horn, Dr Roy Herbst, Global Clinical Head, Lung Cancer Executive Vice President and Lung Cancer Strategy Deputy Director, Yale Cancer Center Oncology Business Sunil Verma, Ingrid Ma
Slide 5: Furthering our oncology ambition @ ASCO 2023
Furthering our oncology ambition @ ASCO 2023 Pascal Soriot CHIEF EXECUTIVE OFFICER
Slide 6: Broad-based, diverse source of revenue
Broad-based, diverse source of revenue Q1 2023 | % Total Revenue by therapy area Q1 2023 | % YoY growth by region, ex. COVID Oncology CVRM R&I V&I Other Rare disease 38% 24% 15% 3% 3% 17% US 15% Europe 9% Q1 2023 | % Total Revenue by geography Emerging Markets 22% US Emerging Markets Europe ERoW 40%
Slide 7: 134 abstracts with 12 oral presentations
134 abstracts with Key data highlights 12 oral presentations 1 plenary presentation ADAURA OS (LBA3) 11 oral presentations DUO-O (LBA5506) 6 poster discussions DESTINY-PanTumor02 (LBA3000) 87 posters TROPION-Lung02 (9004) 5 years of Plenary Presentations 29 online publications Calquence r/r MAIC (75
Slide 8: AstraZeneca 2023 – oncology outlook
AstraZeneca 2023 – oncology outlook Strengthening existing leadership positions and expanding innovative pipeline Reinforce tumour area leadership Advance novel modalities Pursue innovative combinations 9
Slide 9: AstraZeneca in oncology
AstraZeneca in oncology Diverse portfolio of novel modalities and medicines, supporting potential combinations ADCs + RCs ADCs and Cell therapy RCs • Dato-DXd • AZD9592 (EGFR/cMET) • armoured GPC3 CAR-T Cell therapy • AZD8205 (B7-H4) • AZD0901 (CLDN18.2) • NT-125 (TCR-T) Kills cancer cells through D
Slide 10: AstraZeneca oncology momentum in 2023
AstraZeneca oncology momentum in 2023 Pipeline news flow continues with early efficacy signal in Phase III MATTERHORN trial MATTERHORN ADAURA OS FLAURA2 Tagrisso Enhertu Tagrisso + CTx Imfinzi + CTx (FLOT) DPT02 Adjuvant EGFRm HER2-expressing 1L EGFRm NSCLC Neoadj-adjuvant NSCLC tumour types gastric
Slide 11: Setting a new milestone in EGFRm NSCLC
Setting a new milestone in EGFRm NSCLC ADAURA OS Roy Herbst D E P U T Y D I R E C T O R , YA L E C A N C E R C E N T E R A N D S M I L O W C A N C E R H O S P I TA L
Slide 12: ADAURA Phase III trial design
ADAURA Phase III trial design Patients with completely resected stage* IB, II, IIIA NSCLC, with or without Planned treatment duration: adjuvant chemotherapy† Tagrisso 80 mg, 3 years once daily Key inclusion criteria: Treatment continued until: ≥18 years (Japan / Taiwan: ≥20) • Disease recurrence WHO
Slide 13: Adjuvant Tagrisso has significantly improved DFS
Adjuvant Tagrisso has significantly improved DFS ADAURA primary DFS analysis1,2 (stage IBꟷIIIA)* ADAURA updated DFS analysis3,4 (stage IBꟷIIIA)† Published in NEJM October 2020 Published in JCO January 2023 1.0 1.0 0.9 0.9 0.8 0.8 0.7 0.7 DFS probability DFS probability 0.6 0.6 0.5 0.5 Median DFS, mo
Slide 14: Adjuvant Tagrisso has significantly improved CNS DFS
Adjuvant Tagrisso has significantly improved CNS DFS Improved CNS efficacy ADAURA updated CNS DFS analysis4,5 (stage IIꟷIIIA) with Tagrisso treatment Published in JCO January 2023 1.0 • Tagrisso has been shown to achieve 0.9 clinically significant exposure in the brain 0.8 CNS DFS probability compar
Slide 15: Overall survival: patients with stage II/IIIA disease
Overall survival: patients with stage II/IIIA disease Data cut-off: January 27, 2023. 16 Tick marks indicate censored data. Alpha allocation of 0.0497. *Median follow-up for OS (all patients): Tagrisso 59.9 months, placebo 56.2 months. OS = overall survival; HR = hazard ratio; CI = confidence interv
Slide 16: Overall survival: overall population (stage IB/II/IIIA disease)
Overall survival: overall population (stage IB/II/IIIA disease) • Adjuvant Tagrisso demonstrated a statistically and clinically significant improvement in OS vs placebo in the overall population of stage IB-IIIA disease Data cut-off: January 27, 2023. 17 Tick marks indicate censored data. Alpha allo
Slide 17: OS across subgroups: overall population (stage IB/II/IIIA)
OS across subgroups: overall population (stage IB/II/IIIA) Data cut-off: January 27, 2023. 18 *AJCC / UICC 7th edition. OS = overall survival; HR = hazard ratio; CI = confidence interval; PH = proportional-hazards model; EGFR = epidermal growth factor receptor; AJCC = American Joint Committee on Can
Slide 18: Safety summary
Safety summary • At the final DFS analysis (data cut-off: 11 April 2022), all patients had completed or discontinued study treatment; the safety profile of adjuvant Tagrisso with extended follow-up1,2 was consistent with the ADAURA primary analysis3 • At the time of the current data cut-off (27 Janu
Slide 19: Conclusions
Conclusions • In the ADAURA primary analysis, adjuvant Tagrisso demonstrated a statistically significant1 and clinically meaningful DFS benefit vs placebo in resected EGFRm stage IB–IIIA NSCLC, along with improved CNS DFS and a tolerable safety profile1,2 • DFS benefit in ADAURA has translated into
Slide 20: Strengthening presence in lung cancer & advancing emerging portfolio
Strengthening presence in lung cancer & advancing emerging portfolio Susan Galbraith ONCOLOGY R&D Dave Fredrickson ONCOLOGY BUSINESS
Slide 21: Dato-DXd
Dato-DXd Best-in-class TROP2 ADC investigated in monotherapy and novel combinations Dato-DXd Clinical development programme 7 ongoing Phase III trials across supports Dato-DXd strategy NSCLC and breast cancer Potential to replace CTx as monotherapy and as backbone Lung • First Phase III trials in lu
Slide 22: TROPION-Lung02
TROPION-Lung02 Phase Ib investigating Dato-DXd + pembrolizumab ± PDx in 1L/2L+ mNSCLC • Primary objectives: safety and tolerability • Secondary objectives: Key eligibility criteria Dato-DXd pembro platinum CT efficacy, IV Q3W + IV Q3W + IV Q3W pharmacokinetics, and • Advanced/metastatic NSCLC antidr
Slide 23: TROPION-Lung02
TROPION-Lung02 Further follow-up reinforces encouraging efficacy with doublet and triplet regimens • Overall DCR 84% (doublet), 87% (triplet) ― In 1L setting DCR 91% (doublet and triplet • In 1L, ORR 50% (doublet) and 57% (triplet) • mPFS 8.3 months (doublet), 7.8 months (triplet)c • TROPION-Lung02
Slide 24: TROPION-Lung02
TROPION-Lung02 Safety and tolerability profile supports dose for ongoing Phase III 1L trials TEAEs occurred in ≥20% of patients Safety summary Doublet therapy Triplet therapy Stomatiti s 8% 48% 31% 4% • No new safety signals were observed Nausea 2% 39% 43% 4% Anaemia 2% 19% 35% 13% • No adjudicated
Slide 25: Dato-DXd in NSCLC
Dato-DXd in NSCLC Potential to replace current SoC CTx in 2L+ and establish Dato-DXd as backbone in 1L Phase Ib TROPION-PanTumor01 Dato-DXd monotx (3L+ NSCLC, other) 2L+ mono Phase III TROPION-Lung01 Dato-DXd monotx 2L/3L w/ and w/o AGA • Replace current chemotherapy as monotherapy Phase II TROPION-
Slide 26: ARTEMIDE-01
ARTEMIDE-01 Rilvegostomig showed encouraging preliminary anti-tumour activity in CPI-experienced NSCLC Percentage change from baseline in target lesion size over time at RP2D (750mg IV Q3W) Summary and key conclusions • Demonstrated encouraging preliminary anti- tumour activity as 2L+ in pre-treated
Slide 27: Tagrisso
Tagrisso On track to establish Tagrisso as backbone TKI for the treatment of EGFRm NSCLC Metastatic Stage I-III resectable Stage III resectable 1L 2L+ • ADAURA OS expands potential geographic reach in adjuvant ADAURA LAURA FLAURA AURA3 Adjuvant Tagrisso Tagrisso post-CRT Tagrisso Tagrisso ― Closing
Slide 28: AstraZeneca in Lung Cancer
AstraZeneca in Lung Cancer Ambition for >50% of lung cancer patients to be eligible for AZN medicine by 2030 resectable Stg. I-III unresectable Stg. I-II Stg. III 1L metastatic 2L+ Leading the future of Est. epi (G7) ~200K ~30K ~70K ~350K ~290K lung cancer treatment CRT à Imfinzi Imfinzi + Imjudo +
Slide 29: Q&A Session I: Focus on Lung Cancer
AstraZeneca @ ASCO 2023 Q&A Session I: Focus on Lung Cancer KEY EXTERNAL EXPERT M O D E R ATO R S ABBREVIATED BIOGRAPHY Dr Herbst is nationally recognised for his leadership and expertise in lung cancer treatment Susan Galbraith, and research. He is best known for his work in developmental therapeut
Slide 30: Investigating novel combinations in ovarian cancer
Investigating novel combinations in ovarian cancer Susan Galbraith ONCOLOGY R&D
Slide 31: DUO-O Phase III
DUO-O Phase III Investigating combination of Lynparza, Imfinzi, chemotherapy and bevacizumab Run-in phase Chemotherapy phase Maintenance phase CTx cycle 1* CTx† Bevacizumab total 15 months Primary endpoint: + + PFS (RECIST per investigator) in Arm 3 Arm 1 bevacizumab Imfinzi placebo total 24 months
Slide 32: DUO-O Phase III
DUO-O Phase III Significant improvement in HRD-positive and overall population vs chemotherapy + bevacizumab PFS: HRD-positive subgroup (n=431, 38% population*) PFS: ITT (n=1130) 1.0 1.0 90% 0.9 84% 0.9 81% 0.8 85% 0.8 71% 70%ǁ 0.7 0.7 73% PFS probability PFS probability 0.6 69% 0.6 51%ǁ 0.5 0.5 55%
Slide 33: DUO-O Phase III
DUO-O Phase III PFS benefit observed across HRD subgroups PFS: HRD-positive subgroup (n=431, 38% population) PFS: HRD-negative subgroup (n=626, 55% population) 1.0 1.0 90% 0.9 84% 0.9 0.8 0.8 76% 85% 70%* 0.7 0.7 64% PFS probability PFS probability 0.6 85% 0.6 0.5 76% 0.5 67% 69% 40%* 0.4 0.4 63% 0.
Slide 34: DUO-O Phase III
DUO-O Phase III Imfinzi + Lynparza added to CTx + bevacizumab potential new option for patients Conclusions Lynparza data across the entire newly diagnosed ovarian cancer space • Statistically significant and clinically meaningful Non-BRCAm ITT BRCAm improvement in PFS with addition of Imfinzi + Lyn
Slide 35: DUO-E Phase III in advanced endometrial cancer
DUO-E Phase III in advanced endometrial cancer Imfinzi plus Lynparza and Imfinzi alone significantly improved PFS when added to chemotherapy DUO-E Phase III results to be presented at upcoming medical congress 36 PFS = progression-free survival; MMR = mismatch repair; R = randomisation; PC = paclita
Slide 36: Expanding Enhertu beyond breast, lung and gastric
Expanding Enhertu beyond breast, lung and gastric Susan Galbraith ONCOLOGY R&D Dave Fredrickson ONCOLOGY BUSINESS
Slide 37: DESTINY-Pantumor02 Phase II
DESTINY-Pantumor02 Phase II Enhertu for HER2-expressing solid tumors Key trial criteria cervical cancer • Advanced solid tumours not eligible for Primary endpoint curative therapy endometrial cancer • Confirmed ORR • 2L+ patient population (investigator)b ovarian cancer • HER2 expression (IHC 3+ or
Slide 38: DESTINY-Pantumor02 Phase II
DESTINY-Pantumor02 Phase II Clinically meaningful activity observed across broad range of HER2-expressing solid tumours Cervical Endometrial Ovarian BTC Pancreatic Bladder Other All patients (n=40) (n=40) (n=40) (n=41) (n=25) (n=41) (n=40) (n=267) ORR, n (%) 20 (50.0) 23 (57.5) 18 (45.0) 9 (22.0) 1
Slide 39: DESTINY-Pantumor02 Phase II
DESTINY-Pantumor02 Phase II Responses observed in both IHC 3+ and IHC 2+ populations 90 84.6 80 75.0 70 63.6 60 57.5 56.3 56.3 Confirmed ORR, % 50.0 50 47.1 45.0 44.4 40.0 39.0 40 36.8 35.0 30.0 30 22.0 18.8 IHC 3+ IHC 2+ 20 IHC 2+ All 10 IHC 3+ IHC 2+ IHC 3+ IHC 2+ IHC 3+ IHC 2+ IHC 3+ IHC 3+ IHC 2
Slide 40: DESTINY-Pantumor02 Phase II
DESTINY-Pantumor02 Phase II Best percentage change in target lesion from baseline demonstrates depth of response 120 IHC 3+ 100 80 diameters of target lesion from 60 Maximum change in sum of 40 baseline, % 20 0 -20 -40 -60 -80 Cervical Endometrial Ovarian BTC Pancreatic Bladder Othera -100 (n=8) (n=
Slide 41: DESTINY-Pantumor02 in HER2-expressing cancers
DESTINY-Pantumor02 in HER2-expressing cancers Targeting tumours with HER2-expression beyond breast and gastric Estimated prevalence HER2 expression by tumour type Prevalence range • Levels of HER2 expression 50 30-45% differ by tumour type Estimated prevalence (%) 40 23-39% • Variability in prevalen
Slide 42: Reinforcing Calquence positioning in BTKi class
Reinforcing Calquence positioning in BTKi class Anas Younes S V P, H a e m a t o l o g y
Slide 43: Calquence MAIC
Calquence MAIC Methodology uses weighting equation to exactly match baseline characteristics ASCEND vs ALPINE compared through Similar baseline characteristics of ASCEND and ALPINE unanchored MAIC ASCEND trial population Calquence Weighting equation matches baseline characteristics* ASCEND reweighte
Slide 44: Calquence MAIC
Calquence MAIC MAIC demonstrates equivalent PFS in r/r CLL but Calquence more favourable safety Calquence vs zanubrutinib PFS Calquence vs zanubrutinib safety OR (95% CI) 100 SAE 0.61 (0.39–0.97)* AE, grade ≥ 3 0.66 (0.41–1.05) Atrial fibrillation or flutter 75 Any grade 1.15 (0.5–2.65) Investigator
Slide 45: Q&A session
AstraZeneca @ ASCO 2023 Q&A session THERAPEUTIC AREA LEADERSHIP Dave Fredrickson, Leora Horn, Pascal Soriot, Executive Vice President Global Clinical Head, Chief Executive Officer Lung Cancer and Lung Cancer Strategy Oncology Business Sunil Verma, Ingrid Mayer, Susan Galbraith, Global Head of Oncolo
Slide 46: Strengthening oncology leadership
Strengthening oncology leadership ASCO 2023 data reinforces potential to transform patient outcomes in key tumour areas Lung Breast Haematology GI GYN/GU AZD0486 (CD3xCD19 TCE) AZD4573 (CDK9) Dato-DXd capivasertib (AKTi) Dato-DXd capivasertib AZD0466 (BCL2-xL) capivasertib (AKTi) volrustomig camizes
Slide 47: Appendix
Appendix
Slide 48: AstraZeneca in Breast Cancer
AstraZeneca in Breast Cancer Ambition to eliminate breast cancer as a cause of death Early Metastatic established SoC Neoadjuvant Adjuvant 1st line 2nd line 3rd line 4th line + Est. epi (G7) 540k 125k 90k 65k 55k NSTà residual disease à HER2-positive Enhertu +/- THP Enhertu Enhertu Enhertu Enhertu 1
Slide 49: AstraZeneca in HR-positive Breast Cancer
AstraZeneca in HR-positive Breast Cancer Ambition to eliminate breast cancer as a cause of death Early Metastatic established SoC Neoadjuvant Adjuvant 1L 2L 3L 4L+ Est. epi (G7) 405k 80k 65k 55k 50k ER-driven HR+ mBC Camizestant to replace ET e r iv Current SoC drives camizestrant + CDK4/6i Rd o fE
Slide 50: ADAURA DFS
ADAURA DFS Updated disease-free survival data presented at ESMO 2022 Primary endpoint: updated DFS in Stage II/IIIA Updated DFS in the overall population (Stage IB/II/IIIA disease) Median follow-up Tagrisso 44.2 months (range 0 to 67), placebo 19.6 months (range 0 to 70); DFS by investigator assessm
Slide 51: MATTERHORN
MATTERHORN Imfinzi + FLOT showed statistically significant and clinically meaningful pCR improvement MATTERHORN Phase III trial design 52 FLOT = fluorouracil, leucovorin, oxaliplatin and docetaxel; GEJ = gastroesophageal junction cancer; Stg. = Stage; ECOG PS = Eastern Cooperative Oncology Group per
Slide 52: Confirmed ORR in efficacy subset: SoC comparison
Confirmed ORR in efficacy subset: SoC comparison Clinically meaningful responses in DESTINY-Pantumor02 vs 2L SoC1-6 in nearly all cohorts DPT02 Confirmed ORR All Patients vs 2L SoC DPT02 Confirmed ORR by IHC status vs 2L SoC 100 100 90 90 84.6 80 80 75.0 70 70 63.6 60 57.5 60 56.3 56.3 50.0 50 50 47