Astrazeneca Plc · LSE:AZN
Astrazeneca — Investor Day (June 2017)
49 slides from Astrazeneca's investor day presentation, Jun 5, 2017
Slide 1: Taking our science to the 2017 ASCO Annual Meeting
Taking our science to the 2017 ASCO Annual Meeting Investor science event Chicago, IL, USA 05 June 2017
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: Speakers and Q&A participants
Speakers and Q&A participants Pascal Soriot Sean Bohen Executive Vice President, Executive Director and Global Medicines Development Chief Executive Officer and Chief Medical Officer Jamie Freedman Executive Vice President and Head, Oncology Business Unit Rob Iannone Susan Galbraith Head of Immuno-O
Slide 4: Agenda
Agenda Welcome Strategy Pipeline and news flow Summary and Q&A Antibody that blocks inhibitory signals from the tumour to cells of the immune system, resulting in enhanced anti- tumour immunity 4
Slide 5: Key Phase III medicines & lifecycle
Key Phase III medicines & lifecycle Pipeline will determine the rate of growth Cardiovascular & Metabolic Oncology Respiratory Diseases Imfinzi1 ZS-92 benralizumab multiple cancers hyperkalaemia severe, uncontrolled asthma2 / COPD Imfinzi + treme roxadustat2 tralokinumab multiple cancers anaemia sev
Slide 6: Key Phase III medicines & lifecycle: Oncology focus
Key Phase III medicines & lifecycle Oncology has a transformative potential Focus today Cardiovascular & Metabolic Oncology Respiratory Diseases Imfinzi1 ZS-92 benralizumab multiple cancers hyperkalaemia severe, uncontrolled asthma2 / COPD Imfinzi + treme roxadustat2 tralokinumab multiple cancers an
Slide 7: Agenda
Agenda Welcome Strategy Pipeline and news flow Summary and Q&A Antibody that blocks inhibitory signals from the tumour to cells of the immune system, resulting in enhanced anti- tumour immunity 7
Slide 8: Delivering the Oncology strategy at a fast pace
Delivering the Oncology strategy at a fast pace Establishing leadership in lung cancer Emerging as a leader in Immuno-Oncology Advancing Lynparza and the DDR1 portfolio ‘beyond BRCA2’ Developing Haematology 1. DDR = DNA Damage Response. 2. BRCA = BReast CAncer (genes). 8
Slide 9: Establishing leadership in lung cancer
Establishing leadership in lung cancer Unique opportunity across all disease stages Non-small cell lung cancer (~85% of all lung cancers) EGFRm / T790M1 opportunity (~15-20% of patients, double in Asia) IO2 market opportunity (~75-80% of patients) Stage I-III (early / non-metastatic) Stage IV (metas
Slide 10: AstraZeneca in non-small cell lung cancer (NSCLC)
AstraZeneca in non-small cell lung cancer (NSCLC) Overview of approved medicines and ongoing Phase III trials Approved Patients with EGFR- Iressa EGFRm ✓ globally Approved globally ✓ mutated tumours ~15-20% of patients, Tagrisso Tagrisso Tagrisso but double in Asia ADAURA (2021/2022) FLAURA(H2 2017)
Slide 11: Tagrisso: Become the treatment of choice
Tagrisso: Become the treatment of choice Potential to transform EGFRm NSCLC outcomes Extend as the backbone therapy for all EGFRm patients; in early disease and via combinations with other mechanisms Expand the benefit of Tagrisso to 1L and adjuvant EGFRm NSCLC as the new treatment of choice Establi
Slide 12: Imfinzi: Ongoing development programme
Imfinzi: Ongoing development programme Potential for 1L differentiation with tremelimumab Lung cancer NSCLC and small-cell lung cancer (SCLC) Head and neck cancer Bladder cancer Other cancers 12
Slide 13: Lynparza: Advancing 'beyond BRCA'
Lynparza: Advancing ‘beyond BRCA’ Earlier lines, new tumours, more mutations 1st PARP1 Expand to Beyond inhibitor earlier lines BRCA Study 19 / SOLO-2 PROFOUND BRCAm ovarian cancer SOLO-1 prostate cancer 1L BRCAm ovarian cancer OlympiAD PAOLA BRCAm metastatic combination ovarian cancer breast cancer
Slide 14: Developing Haematology
Developing Haematology Next wave Collaboration with Cell respected partner death ADC1 IO Acalabrutinib • B-cell blood cancers Moxetumomab • Hairy cell leukemia (HCL) 1. ADC = Antibody Drug Conjugate. Illustrative. 14
Slide 15: Oncology: Scientific leadership around four key platforms
Oncology: Scientific leadership around four key platforms Opportunity for novel combinations Tumour drivers DNA damage Immuno-Oncology Antibody-drug and resistance response conjugates 15
Slide 16: Agenda
Agenda Welcome Strategy Pipeline and news flow Summary and Q&A Antibody that blocks inhibitory signals from the tumour to cells of the immune system, resulting in enhanced anti- tumour immunity 16
Slide 17: ASCO Annual Meeting presence almost doubled
ASCO Annual Meeting presence almost doubled Relevance of AstraZeneca in Oncology is fast increasing Accepted abstracts 100 100 company-sponsored and supported abstracts at ASCO. This includes five ‘Best of ASCO’ presentations, and a total of 11 oral presentations and eight poster discussions. 58 Hig
Slide 18: Oncology: Scientific leadership around four key platforms
Oncology: Scientific leadership around four key platforms Opportunity for novel combinations Tumour drivers DNA damage Immuno-Oncology Antibody-drug and resistance response conjugates 18
Slide 19: NSCLC: Stage IV metastatic disease
NSCLC: Stage IV metastatic disease Potential to benefit the majority of patients Typical non-Asian NSCLC-patient segmentation Typical Asian NSCLC-patient segmentation ALK inhibitors ALK inhibitors EGFR inhibitors EGFR inhibitors IO market IO market opportunity opportunity Imfinzi and Imfinzi and Imf
Slide 20: Tagrisso: First randomised Phase III trial to demonstrate superiority
Tagrisso First randomised Phase III trial to demonstrate superiority AURA3 - 2L T790M NSCLC Investigator assessment1 PFS by Tagrisso Chemo investigator (N=279) (N=140) 0.30 (0.23; 0.41) HR (95% CI) p<0.001 Median PFS, 10.1 4.4 months (95% (8.3; 12.3) (4.2; 5.6) CI) Tagrisso With CNS metastases PFS b
Slide 21: Tagrisso: Encouraging long-term CNS benefit supports 1L use
Tagrisso Encouraging long-term CNS benefit supports 1L use Tagrisso crosses the blood-brain barrier Potential in 1L EGFRm NSCLC Tony Mok, discussion of Tagrisso data, ELCC, Geneva, Switzerland 13 April 2016 60 EGFRm patients who received Tagrisso AURA17: Radiological response of leptomeningeal lesio
Slide 22: Tagrisso: Potential to transform EGFRm NSCLC outcomes
Tagrisso Potential to transform EGFRm NSCLC outcomes 3 From 2021 Extend as the backbone therapy for all EGFRm patients; in early disease and via 2 From 2018 combinations with other mechanisms1 Expand the benefit of Tagrisso to 1L and 1 At launch (2015-17) adjuvant EGFRm NSCLC as the new treatment of
Slide 23: Acalabrutinib: Extensive clinical trial programme underway
Acalabrutinib Extensive clinical trial programme underway 21 clinical trials underway with +2,000 patients - excerpts: Solid tumours Indication Line of therapy; trial design Phase Front line Follicular L. acalabrutinib + obinutuzumab vs. obinutuzumab + chlorambucil vs. acalabrutinib III Lymphoma Rel
Slide 24: Oncology: Scientific leadership around four key platforms
Oncology: Scientific leadership around four key platforms Opportunity for novel combinations Tumour drivers DNA damage Immuno-Oncology Antibody-drug and resistance response conjugates 24
Slide 25: Lynparza: Ovarian cancer
Lynparza: Ovarian cancer Compelling efficacy and safety Compelling efficacy from SOLO-2 Compelling safety data, patient convenience (ovarian cancer 2L maintenance) % (events, n) Anemia Neutropenia Thrombocytopenia Investigator assessment Grade ≥3 Grade ≥3 Grade ≥3 SOLO-2 19.5% (38) 5.1% (10) 1.0% (2
Slide 26: Lynparza: Breast cancer OlympiAD study design
Lynparza: Breast cancer OlympiAD study design • HER2-negative metastatic breast cancer Primary endpoint Progression-free survival ̶ ER+ and/or PR+ or (RECIST 1.1, BICR) Treat until progression ̶ TNBC Olaparib 300 mg tablets bd Secondary endpoints • Deleterious or suspected deleterious gBRCAm • Overa
Slide 27: Lynparza: Breast cancer adverse events
Lynparza: Breast cancer Grade ≥3 adverse events in ≥2% patients in either arm Anemia 16 4 Neutropenia 9 26 Decreased white blood cells 3 10 Fatigue 3 1 Leukopenia 2 3 Decreased platelet count 2 1 Increased AST 2 0 Dyspnea 1 3 Headache 1 2 Olaparib 300 mg bd (N=205) P-PES 0 2 Chemotherapy TPC (N=91)
Slide 28: Lynparza: Breast cancer primary endpoint PFS by BICR
Lynparza: Breast cancer Primary endpoint: progression-free survival by BICR 100 Olaparib Chemotherapy 90 300 mg bd TPC 80 Progression/deaths, n (%) 163 (79.5) 71 (73.2) 70 Median PFS, months 7.0 4.2 HR 0.58 PFS (%) 60 50 95% CI 0.43 to 0.80; P=0.0009 40 30 20 10 0 0 2 4 6 8 10 12 14 16 18 20 22 24 2
Slide 29: Lynparza: Expanding beyond BRCA
Lynparza: Expanding beyond BRCA Strategy; expected regulatory submissions Driving life-cycle programme Key data readouts PROFOUND prostate cancer PAOLA bevacizumab Lynparza Combination with DDR combination + AZD6738 Increasing efficacy ovarian (ATR) cancer Combination with IO Combination POLO Lynpar
Slide 30: DNA damage response (DDR)
DNA damage response (DDR) Deep portfolio from preclinical to launch Launched / Preclinical Phase I Phase II Phase III Effect is manifest in M phase DNA-PK1 AZD1390 AZD6738 Lynparza (DSB2 repair) (ATM3) (ATR4) (PARP) AZD0156 AZD1775 (ATM) (WEE1) Prevent repair AZD2811 Maximise (Aurora B) damage G1 =
Slide 31: Lynparza + Imfinzi (MEDIOLA trial)
Lynparza + Imfinzi (MEDIOLA trial) Leading with novel anti-PDL1 plus targeted-therapy combinations gBRCAm ovarian 3L and later platinum sensitive N=30 Baseline tumour Repeat tumour Repeat tumour biopsy gBRCAm HER2-negative biopsy and blood biopsy and blood and blood: C2D1 breast 1L, 2L, 3L not plati
Slide 32: Oncology: Scientific leadership around four key platforms
Oncology: Scientific leadership around four key platforms Opportunity for novel combinations Tumour drivers DNA damage Immuno-Oncology Antibody-drug and resistance response conjugates 32
Slide 33: Imfinzi: Bladder cancer 2L
Imfinzi: Bladder cancer 2L First approval; compelling data All patients PD-L high PD-L1 PD-L1 NE1 low/negative N=182 N=95 N=73 N=14 Objective Response Rate (ORR) by BICR, 31 (17.0%) 25 (26.3%) 3 (4.1%) 3 (21.4%) n (%) (95% confidence (11.9, 23.3) (17.8, 36.4) (0.9, 11.5) (4.7, 50.8) interval [CI]) C
Slide 34: Imfinzi: Stage III NSCLC
Imfinzi: Stage III NSCLC PACIFIC trial: First and only IO medicine with PFS PACIFIC Key facts • ~100,000 patients are diagnosed with Stage III lung cancer each year in G7; about half being unresectable • Trial will continue for overall survival with final overall survival data currently expected in
Slide 35: Imfinzi: Stage III NSCLC PACIFIC trial
Imfinzi: Stage III NSCLC PACIFIC trial: Statistically-significant and clinically-meaningful PFS Stage IIIa and IIIb No progression Stage IV 1st line Disease free >12M Progression Locally-advanced / advanced CTx1 + RTx2 unresectable NSCLC Delay or Disease free <12M potentially 2nd line avoid progress
Slide 36: Imfinzi: Stage IV NSCLC MYSTIC trial
Imfinzi: Stage IV NSCLC MYSTIC trial: Multiple potential outcomes 2017 2018 Primary endpoints Imfinzi + treme combo Mid-2017 PFS in ‘expressers’ PFS final analysis Imfinzi + treme combo OS interim analyses OS in ‘expressers’ OS final analysis Imfinzi OS interim analyses OS in ‘expressers’ OS final a
Slide 37: Imfinzi: Stage Ib-IV NSCLC Extensive Phase III programme
Imfinzi: Stage Ib-IV NSCLC Extensive Phase III programme ADJUVANT PACIFIC MYSTIC NEPTUNE PEARL POSEIDON ARCTIC Stage Ib-IIIa Stage III Stage IV / 1L Stage IV / 1L Stage IV / 1L Stage IV / 1L Stage IV / 3L unresectable EGFR/ALK wt EGFR/ALK wt EGFR/ALK wt EGFR/ALK wt EGFR/ALK wt Non-sq / sq2 Non-sq /
Slide 38: Imfinzi: Key news flow
Imfinzi: Key news flow Mono and combo w/treme = Imfinzi = Imfinzi +/- treme ✔ = fully recruited ✔ 2 Bladder cancer DANUBE (UC1) 1L Head and neck cancer KESTREL 1L ✔ EAGLE 2L Lung cancer POSEIDON (NSCLC) 1L IO-IO-CTx triple NEPTUNE 1L (final OS) ✔ PEARL 1L (Asia) MYSTIC 1L (PFS) ✔ ARCTIC ✔ 3L PD-L1 l
Slide 39: Next-generation Immuno-Oncology
Next-generation Immuno-Oncology With an entrepreneurial spirit and a relentless drive to push the boundaries of science, our early biotech units work every day to redefine the treatment paradigm and ultimately eliminate cancer as a cause of death 39
Slide 40: Cancer may arise when tumour cells escape immune pressure
Next-generation Immuno-Oncology Cancer may arise when tumour cells escape immune pressure Immune surveillance Escape from immune pressure T-cell priming and activation Weak immune response Antigen uptake and presentation Absent immune Suppressed response immune response Release of Killing of cancer
Slide 41: Broad IO clinical programme to enhance anti-tumor immunity
Next-generation Immuno-Oncology Broad IO clinical programme to enhance anti-tumor immunity Prime new response Potentiate existing response TLR 7/8 HDAC1 PD-L1 hOX402 PD-1 DNA HPVE71 T vaccine CTLA-4 GITR NKG2A CD73 A2AR CXCR2 Ongoing Imfinzi STAT3 IDO1 IMCgp1001 combination Reverse local 1. Clinical
Slide 42: Oncology: Scientific leadership around four key platforms
Oncology: Scientific leadership around four key platforms Opportunity for novel combinations Tumour drivers DNA damage Immuno-Oncology Antibody-drug and resistance response conjugates 42
Slide 43: ADC: Growing antibody-drug conjugate programme
ADC: Growing antibody-drug conjugate programme Now four clinical-stage programmes Phase III Phase I Proprietary moxetumomab antibody-drug conjugates payloads • Promising activity in • HER2 biparatopic (tubulysin) relapsed/refractory HCL • PSMA (PBD) • Target not disclosed (PBD) U n tre a te d N M E
Slide 44: Transformative potential of Oncology
Transformative potential of Oncology PACIFIC Phase III trial only one opportunity Faslodex Lynparza breast cancer 1L ovarian cancer 2L Reg. decisions Reg. decision (US) acalabrutinib Lynparza Imfinzi Lynparza blood cancer ovarian cancer 2L lung cancer Stage III breast cancer Phase II/reg. submission
Slide 45: Agenda
Agenda Welcome Strategy Pipeline and news flow Summary and Q&A Antibody that blocks inhibitory signals from the tumour to cells of the immune system, resulting in enhanced anti- tumour immunity 45
Slide 46: Summary
Summary 1 Significant progress made in Oncology strategy execution 2 Lynparza and DDR portfolio expanding beyond ovarian cancer and BRCA 3 Establishing lung cancer leadership through Tagrisso and Imfinzi +/- treme 4 Development of Haematology gaining momentum 5 Oncology pipeline with transformative
Slide 47: Questions & answers
Questions & answers Please press *1 on your phone if you wish to ask a question or use the dedicated Q&A facility on the webcast Q&A • Pascal Soriot, moderator • Sean Bohen • Jamie Freedman • Rob Iannone • Klaus Edvardsen • Susan Galbraith • David Berman Investor science event expected to end at 8:3
Slide 48: Use of AstraZeneca webcast, conference call and presentation slides
Use of AstraZeneca webcast, conference call 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 availab
Slide 49: Taking our science to the 2017 ASCO Annual Meeting
Taking our science to the 2017 ASCO Annual Meeting Investor science event Chicago, IL, USA 05 June 2017