Slide 1: Meet AZN management: Oncology
Meet AZN management: Oncology 2021 ASCO Annual Meeting Dave Fredrickson, Executive Vice President, Oncology Business Unit 7 June 2021 Interactive event for investors and analysts. This webinar is being recorded. https://astrazeneca.zoom.us/s/99688625459
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 Oncology
AstraZeneca Oncology We are leading a revolution in oncology to redefine cancer care Our ambition is to provide cures for cancer in every form. We are following the science to understand cancer and all its complexities to discover, develop and deliver life-changing treatments and increase the potent
Slide 4: Oncology: a leading, diversified portfolio
Oncology: a leading, diversified portfolio1 Lung cancer Multiple cancers Multiple cancers Blood cancers • Stage IV NSCLC2 • Stage III, unresectable • Ovarian, breast, • Breast cancer (3L9, • Chronic lymphocytic - EGFRm3 (1L4) NSCLC pancreatic, prostate HER2+10) and gastric leukaemia - T790M5 (2L6) c
Slide 5: Oncology: strong launch and commercial execution capabilities
Oncology: strong launch and commercial execution capabilities Lung cancer Multiple cancers Multiple cancers Blood cancers $m 1,200 600 600 50 250 1,000 500 500 40 200 800 400 400 30 150 600 300 300 20 100 400 200 200 10 50 200 100 100 0 0 0 0 0 15 16 16 17 17 18 18 19 19 20 20 21 17 18 18 19 20 21 1
Slide 6: ASCO 2021 data presentations and highlights
90 abstracts with Data 74 presentations highlights ASCO 2021 • Lynparza • One plenary session (Lynparza OlympiA Phase III adjuvant breast Another strong OlympiA Phase III trial) cancer presence • 12 oral presentations • Calquence ELEVATE-TN Phase III 4-year • 14 poster discussions follow-up ELEVATE-
Slide 7: Agenda
Agenda Lung cancer Breast cancer Haematology ‘What’s next’ Q&A 7
Slide 8: Lung cancer
Lung cancer Mohit Manrao, Global Franchise Head, Tagrisso and lung cancer Greg Rossi, Global Franchise Head, Immuno-Oncology For additional questions and IR support, please email tom.waldron@astrazeneca.com.
Slide 9: Transforming lung cancer by embracing entire patient journey
Transforming lung cancer by embracing entire patient journey Translating science to evidence, and evidence to practice Personalise treatment Diagnose and treat early Improve quality of care • NSCLC and SCLC • Increase screening and early diagnosis • Integrated remote care • Tumour drivers and resist
Slide 10: Tagrisso: changing treatment expectations in EGFRm NSCLC
Tagrisso: changing treatment expectations in EGFRm NSCLC Continuing to push the boundaries of science and patient care Reshaping the treatment paradigm Enabling maximal patient benefit globally by moving into earlier lines of NSCLC Globally Embedded Access Globally-embedded access 1 • First EGFR TKI
Slide 11: Tagrisso: building new EGFRm standard of care in NSCLC
Tagrisso: building new EGFRm standard of care in NSCLC Clinical trials across the NSCLC continuum Early stage Late stage Resectable Unresectable 1st line 2nd line+ Stage I-II AURA3 FLAURA Post-Tagrisso combinations Neo- Stage IA ADAURA ORCHARD | SAVANNAH ADAURA Other combinations LAURA FLAURA2 Non-T
Slide 12: Enhertu, datopotamab deruxtecan: ADC portfolio
Enhertu, datopotamab deruxtecan: ADC1 portfolio Significant activity across NSCLC Enhertu - HER2 ADC (DESTINY-Lung01 trial) Datopotamab deruxtecan - TROP26 ADC (TROPION-PanTumor01 trial) ORR2 62%, mPFS 14m Best Overall Response (BICR) (n=39, 6.4mg/kg, 2L median prior Tx, 76% post-PDx3) HER2m4 NSCLC
Slide 13: Imfinzi: immuno-oncology
Imfinzi: immuno-oncology Unique position in lung cancer Comprehensive programme in Strong launch Novel early lung builds on PACIFIC in ES-SCLC2 combinations PACIFIC updated OS (ITT1) CASPIAN HUDSON Phase II + ceralasertib A SCO 2 0 2 A SCO 2 0 2 W C LC 2 0 2 1 0 0 • 43% of patients alive at five yea
Slide 14: NSCLC: leadership across the spectrum
NSCLC: leadership across the spectrum Potential to cover most patients across settings and lines of treatment Stage I-IIIB neo-adjuvant Stage I-IIIB resectable/ early/adjuvant Stage I-IIIB Metastatic Metastatic unresectable resectable unresectable 1st line 2nd line+ EGFR Tagrisso monotherapy and Tag
Slide 15: Breast cancer
Breast cancer Cristian Massacesi, Senior Vice President, Oncology R&D, late-stage development Sunil Verma, Vice President, Oncology R&D, late-stage development breast cancer For additional questions and IR support, please email nick.stone@astrazeneca.com.
Slide 16: Breast cancer: medicines have helped patients for more than four decades
Breast cancer: AstraZeneca’s pioneering medicines have helped patients for more than four decades 1970’s 1980’s 1990’s On the World Health Organization’s list of Lutenising hormone-releasing agonist of choice for One of the gold-standard medicines for essential drugs for the treatment of breast canc
Slide 17: Breast cancer: bold 10-year ambition to transform survival
Breast cancer: AstraZeneca has a bold 10-year ambition to transform survival Smarter Earlier Harder Redefine the treatment paradigm and Bring impactful medicines where Establish foundational medicines that enable a more personalised approach there is an opportunity for cure set new benchmarks in out
Slide 18: Lynparza: potential new standard of care
Lynparza: potential new standard of care Now BRCAm adjuvant breast cancer Lynparza demonstrated a sustainable and clinically relevant treatment effect versus placebo for patients1 2.3 million women diagnosed with breast cancer in 2020 5% breast cancer patients with BRCA mutation 50% of women diagnos
Slide 19: Enhertu: transforming HER2+ and redefining HER2-low BC
Enhertu: transforming HER2+ and redefining HER2-low BC Clinical development programme across multiple lines and subtypes Launched in 3L, HER2+ mBC1 BEGONIA: Imfinzi + Enhertu, Upcoming Enhertu breast HER2-low 1L mTNBC2 cancer data readouts • Total revenue $40m; US $35m in Q1 2021 $73m US in-market s
Slide 20: Enhertu: clinical development programme
Enhertu: clinical development programme Opportunities across breast cancer, HER2-low and other tumours Neo-adjuvant / adjuvant 1L metastatic 2L metastatic 3L metastatic 2x Phase III HR+1: chemotherapy ± endocrine Post HER2-low therapy endocrine ± CDK4/6i2 CDK4/6i breast cancer HR-3: chemotherapy Rep
Slide 21: Breast cancer: competitive late-stage breast cancer pipeline
Breast cancer: competitive late-stage breast cancer pipeline Phase III trials underway and planned Capivasertib (AZD5363): Camizestrant (AZD9833): Datopotamab deruxtecan oral AKT inhibitor next-generation oral SERD (DS-1062): TROP2 ADC Breast Phase III trials underway Encouraging monotherapy efficac
Slide 22: Breast cancer: well-positioned with at least six medicines
Breast cancer: well-positioned with at least six medicines Potential to cover most patients across settings and lines of treatment Early/curative setting Metastatic setting Neo-adjuvant Adjuvant 1st line 2nd line 3rd line 3rd line+ HER2+ Enhertu monotherapy Enhertu monotherapy c.20% of patients and
Slide 23: Haematology
Haematology Niko André, Global Franchise Head, Haematology and Calquence Anas Younes, Senior Vice President, Oncology R&D, haematology For additional questions and IR support, please email thomas.larsen@astrazeneca.com.
Slide 24: Calquence: a standard of care in chronic lymphocytic leukaemia
Calquence: a standard of care in chronic lymphocytic leukaemia Relapsed/refractory (R/R) Front line (FL) ASCEND Phase III trial ELEVATE-TN Phase III trial IRC-Assessed Progression-Free Survival • Font: Calibri 18pt. Median follow-up 28.3 months 100 93% • Box, bullets to match header colour Progressi
Slide 25: Calquence: launch trajectory confirms clinical value
Calquence: launch trajectory confirms clinical value Inflection point from chronic lymphocytic leukaemia uptake Solid launch US: high up- Ex-US: Europe launch and $m trajectory take in CLL2 reimbursement underway 250 • CLL c.3/4 of all Calquence use • Approval 60 countries (CLL) and 27 (MCL3) 200 •
Slide 26: Calquence: CLL launches
Calquence: CLL launches Global rollout in three waves 1st wave 3rd wave Approval Regulatory US Q4 2019 submission CN 2022 93% of sales in Q1 2021 2nd wave Approvals EU Q4 2020 JP Q1 2021 Launch in DE, FR, UK with IT, ES in H2 2021 26 Sales in >25 countries
Slide 27: Calquence at ASCO: ELEVATE-TN Phase III trial
Calquence at ASCO: ELEVATE-TN Phase III trial Sustained patient benefit at four years in a front-line setting Overall population Patients with del(17p) and/or mutated TP53 Hazard ratio was based on unstratified Cox-Proportional-Hazards model; P-value was based on unstratified log-rank test. Notes: A
Slide 28: Calquence at ASCO: ELEVATE-RR Phase III trial vs. ibrutinib
Calquence at ASCO: ELEVATE-RR Phase III trial vs. ibrutinib Lower incidences of any-grade atrial fibrillation/flutter; solid safety overall Afib/Flutter Calquence (acalabrutinib) Calquence (acalabrutinib) Any grade Grade ≥3 Acalabrutinib Ibrutinib Acalabrutinib Ibrutinib Events, n (%) (n=266) (n=263
Slide 29: Haematology: projects in early development
Haematology: projects in early development Emerging pipeline in main haematology indications Broad portfolio First immunotherapy Tumour drivers in cell death bispecific antibody of resistance Target/ medicine Bcl-21 Bcl-xL BFL1 MCL12 idelalisib venetoclax duvelisib PD-19 TIM3 copanlisib AZD0466 (Bcl
Slide 30: Haematology: 'What's next'
Haematology: ‘What’s next’ Growing pipeline across medicines and indications AML/ CLL/SLL1 MCL DLBCL2 FL/MZL3 MM4 Other MDS Tumour drivers of resistance Calquence (BTK) capivasertib (AKT) New targets Cell death AZD4573 (CDK9) AZD5991 (MCL1) AZD0466 (Bcl-2/xL) New targets IO / bispecifics / cell ther
Slide 31: 'What's next'
‘What’s next’ Susan Galbraith, Senior Vice President, Oncology R&D, early stage Andrew Mortlock, Vice President, Oncology R&D, haematology projects For additional questions and IR support, please email henry.wheeler@astrazeneca.com.
Slide 32: Comprehensive portfolio to combat cancer
Comprehensive portfolio to combat cancer Oncology ambition Attained through diversity in portfolio Tumour drivers Oncogenic truncal drivers and Redirect local immunity Immune and resistance mechanisms of resistance Awaken dormant immune cells engagers Tumor burden DNA damage Synthetic lethality expl
Slide 33: What's next? Selectively expanding technologies and platforms
What’s next? Selectively expanding technologies and platforms DDR Next-wave IO Next-wave modalities AZD2811 (Aurora B kinase) ATTACK Adavosertib (WEE11 ) ADCs & RIC4s Death in mitosis Prevent repair M Eliminate G2 tumor G1 Acquired resistance PROTAC5s Lynparza (PARPi) S Maximise damage AZD6738 Tumor
Slide 34: Advancing the DDR portfolio
Advancing the DDR portfolio Key data at ASCO and AACR AZD5305 EFFORT HUDSON PARP-1 selective inhibitor Adavosertib Phase II trial Umbrella NSCLC platform post-IO Adavosertib monotherapy • Five abstracts at AACR1 • Selective PARP1-DNA trapper 20% increase • More potent and efficacious than first- gen
Slide 35: Next-wave IO: Clinical-stage progress
Next-wave IO Clinical-stage progress Key Phase II Imfinzi AZD7789 AZD8853 combination trial readouts PD1/TIM3 bispecific Anti-GDF15 OE21 OE21 Humanised 10xGS 10xGS -v3 mouse model -v3 OE21 10xGS- V3 Imfinzi + oleclumab (CD731) or 1500 1500 R347 R347 Isotype Isotype Survival Ctl Ctl * Percent Surviva
Slide 36: Next-wave modalities
Next-wave modalities Innovative use of new modalities to deliver transformational change ADCs & RICs PROTACS Genomics capabilities Pharmacology, CRISPR screens and DepMap- 6 stability enhancing target identification PK/PD, Kd, Tox, TI 1 Target density 5 Warhead MOA 2 Internalisation kinetics 4 Bysta
Slide 37: Early-stage oncology pipeline
Early-stage oncology pipeline Phase I Phase II MEDI1191 AZD0466 oleclumab modIL-12 BcI2-xL CD73 IPH5201 AZD5991 imaradenant CD39 MCL1 A2AR1 AZD5069 AZD1390 MEDI5752 CXCR2-ESR ATM PD-1/CTLA42 AZD0171 AZD7648 MEDI0457 LIF1 DNAPK HPV Vax AZD8701 AZD5305 camizestrant FOXP3 ASO PARP1Sel SERD MEDI5395 AZD
Slide 38: 'What's next': Phase I/II new medicines, selected
‘What’s next’ Phase I/II new medicines, selected What’s now Phase III new medicines datopotamab deruxtecan camizestrant lung cancer breast cancer monalizumab capivasertib head & neck cancer breast, prostate cancer adavosertib ceralasertib savolitinib tremelimumab (WEE1 inhibitor) (ATR inhibitor) NSC
Slide 39: Questions & Answers
Questions & Answers To ask a question Webinar Click ’Raise Hand’ (preferred): or type your question into the Q&A box (alternative) Phone *6 - Toggle mute/unmute *9 - Raise hand 39
Slide 40: Use of AstraZeneca conference call, webcast and presentation slides
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