Oncology and Haematology
David Fredrickson, EVP, Oncology Business Susan Galbraith, EVP, Oncology R&D
Cristian Massacesi, CMO & Oncology Chief Development Officer Anas Younes, SVP, Global Head of Haematology, Oncology R&D Sunil Verma, SVP, Global Medical Affairs
Matt Hellmann, VP, Early Oncology Development
Investor Day • 2024
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 with respect to the operations, performance and financial condition of the Group, including, among other things, statements about expected or targeted revenues, margins, earnings per share or other financial or other measures (including the Financial Ambition Statements described in this presentation). Although the Group believes its expectations and targets are based on reasonable assumptions and has used customary forecasting methodologies used in the pharmaceutical industry and risk-adjusted projections for individual medicines (which take into account the probability of success of individual clinical trials, based on industry-wide data for relevant clinical trials at a similar stage of development), any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of this document and the Group undertakes no obligation to update these forward-looking statements. The Group identifies the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond the Group's control, include, among other things: the risk of failure or delay in delivery of pipeline or launch of new medicines; the risk of failure to meet regulatory or ethical requirements for medicine development or approval; the risk of failures or delays in the quality or execution of the Group's commercial strategies; the risk of pricing, affordability, access and competitive pressures; the risk of failure to maintain supply of compliant, quality medicines; the risk of illegal trade in the Group's medicines; the impact of reliance on third-party goods and services; the risk of failure in information technology or cybersecurity; the risk of failure of critical processes; the risk of failure to collect and manage data in line with legal and regulatory requirements and strategic objectives; the risk of failure to attract, develop, engage and retain a diverse, talented and capable workforce; the risk of failure to meet regulatory or ethical expectations on environmental impact, including climate change; the risk of the safety and efficacy of marketed medicines being questioned; the risk of adverse outcome of litigation and/or governmental investigations; intellectual property-related risks to the Group's products; the risk of failure to achieve strategic plans or meet targets or expectations; the risk of failure in financial control or the occurrence of fraud; the risk of unexpected deterioration in the Group's financial position; the impact that global and/or geopolitical events may have, or continue to have, on these risks, on the Group's ability to continue to mitigate these risks, and on the Group's operations, financial results or financial condition There can be no guarantees that the conditions to the closing of the proposed transaction with Fusion will be satisfied on the expected timetable, or at all, or that "FPI-2265"(Ac225-PSMA I&T) or any combination product will receive the necessary regulatory approvals or prove to be commercially successful if approved. There can be no guarantees that the conditions to the closing of the proposed transaction with Amolyt Pharma will be satisfied on the expected timetable, or at all, or that eneboparatide ('AZP-3601') will receive the necessary regulatory approvals or prove to be commercially successful if approved.
This presentation includes references to new molecular entities and life-cycle management programmes that are being investigated in current or future clinical trials, and as such have not been approved by any regulatory agency. For a list of new molecular entities and indications in development, see pages 7-11 of the Clinical Trials Appendix that accompanied AstraZeneca's Q1 2024 results.
Basis of AstraZeneca ambitions, forecasts and targets
AstraZeneca ambitions, forecasts and targets in this presentation (the "Financial Ambition Statements") are derived from AstraZeneca's most recent risk-adjusted mid- and long-term plans, adjusted for developments in the business since those plans were finalised. Financial Ambition Statements presented are based on management's risk-adjusted projections for individual medicines and individual clinical trials. Estimates for these probabilities are based on industry-wide data for relevant clinical trials in the pharmaceutical industry at a similar stage of development adjusted for management's view on the risk profile of the specific asset. The peak year revenue (PYR) potential for individual medicines referred to in this presentation are the maximum estimated Total Revenue to be recognised by AstraZeneca in a single calendar year, during the lifecycle of the medicine, and are based on management's latest non-risk adjusted forecast estimates. Estimates are based on customary forecasting methodologies used in the pharmaceutical industry. Peak year revenue may occur in different years for each NME depending on trial outcomes, approval label, competition, launch dates and exclusivity periods, amongst other variables. The peak year revenue figures are derived from net sales at nominal values and are not risk-adjusted or time-value discounted. The development of pharmaceutical products has inherent risks given scientific experimentation and there are a range of possible outcomes in clinical results, safety, efficacy and product labelling. Clinical results may not achieve the desired product profile and competitive environment, pricing and reimbursement may have material impact on commercial revenue forecasts. By their nature, forecasts are based on a multiplicity of assumptions and actual performance in future years may vary, significantly and materially, from these assumptions. The Financial Ambition Statements in this presentation are based on Q1 2024 exchange rates; AZ undertakes no obligation to update those statements based on future currency movements
2 | Investor Day • 2024 |
Unmet need in cancer remains a global challenge
Five million new cancer patients diagnosed globally1 per year with low 5-year survival
1L 5yr
survival
Lung 5-10%
Breast 30%
Prostate 30%
Gastric 5-10%
Liver <5%
Endo 15-20%
Ovarian 30%
Solid tumours2
New cases ('000), 2022
350k
130k
200k
350k
150k
370k
130k
80k
60k
60k
G7 | China | 1L 5yr | Haematology3 | G7 | China | |
survival New cases ('000), 2022 | ||||||
600k | DLBCL/ | 50% | 110k | |||
1,050k | FL | 40k | ||||
650k | MM | 55% | 70k | |||
20k | ||||||
600k | AML | 10% | 40k | |||
20k | ||||||
CLL | 70% | 40k | ||||
10k | ||||||
B-ALL | ||||||
35% / 85% | 10k | |||||
adult paed. | 10k |
1. 5 million patients across G7 markets (US, UK, FR, DE, IT, ES, JP) and China. 2. Solid tumours: new cases: Globocan; survival rates: 3. American Cancer Society. Haematology: new cases: Cerner Enviza, survival rates (PFS/EFS): literature review. | Investor Day • 2024 |
3 Acronym definitions can be found in Glossary. |
Critical trends in transforming cancer treatment
Novel ADCs and Radioconjugates
Novel IO
Cell therapy and T-cell engagers
Powerful combinations
Early intervention
1
12
13
14
15
Replace the backbone of chemotherapy and radiotherapy
Next wave of IO agents will segment the IO-sensitive space
Scalable, accessible therapies in both liquid and solid tumours
Transform outcomes with novel ADC, Radioconjugate and next-generation IO combinations
Improve long-term outcomes with neoadjuvant combinations
4 ADC = Antibody drug conjugates; IO = immuno-oncology. Acronym definitions can be found in Glossary. | Investor Day • 2024 |
Our strategy to transform patient outcomes
Attack cancer from | Treat earlier and smarter |
multiple angles | |
Treatment journey today |
Future treatment journey
Lead with
innovative technology
Data and AI in clinical trials
HER2 Accelerating computational
TROP2 pathology
Improving patient outcomes through digital health
5 Acronym definitions can be found in Glossary. | Investor Day • 2024 |
Powerful combinations to transform survival in cancer
Kill cancer cells, debulk tumour and activate | Enhance immune system when checkpoint | |||
immune system with checkpoint inhibitors | inhibition alone is insufficient | |||
ADCs | Radioconjugates | IO bispecifics | T-cell engagers | CAR-Ts |
Debulk tumour with ADCs or
Radioconjugates, clear
micro-metastatic disease with
cell therapy or T-cell engagers
ADCs and Radioconjugates potential to
replace systemic chemotherapy, combine with novel IO bispecifics
PARP1 inhibitors to potentiate clinical
benefit of ADCs and Radioconjugates
6 Acronym definitions can be found in Glossary. | Investor Day • 2024 |
We are leading the ADC revolution to replace systemic chemotherapy
Significant potential ADC opportunity across multiple tumours
Estimated number of patients treated with ADCs at peak (est. G7, 000s)1
2
2
AstraZeneca robust ADC portfolio
with proven execution
Strong foundation in ADCs
Six clinical-stage internal ADCs
B7H4 • CLDN18.2 • CD123
EGFR/cMET • GPRC5D • FRα
Combination opportunities
with IO and DDR
1. AZ internal estimates. G7 proportion of patients treated with Chemotherapy CancerMPact®, Cerner Enviza. 2. AGA actionable genomic alterations in NSCLC (e.g. EGFR, ALK, ROS1, RET, MET, NTRK, BRAF). Acronym definitions can be found 7 in Glossary.
Investor Day • 2024
Enhertu - leading HER2 ADC with transformational data across multiple tumour types
OS probability (%)
DESTINY-Breast031 | DESTINY-Breast042 | DESTINY-PanTumor023 |
HER2+ 2L+ breast cancer | HER2-low 3L+ breast cancer | HER2+ 2L+ tumours4 |
100 | 100 | 100 | Median OS in months (95% CI) | ||
0.64 OS HR | 0.69 OS HR | ||||
90 | All cohorts: IHC 2+ 12.2 (10.7, 13.5) | ||||
All cohorts: IHC 3+ 21.1 (15.3, 29.6) | |||||
80 | 80 | 80 | All cohorts: Total 13.4 (11.9, 15.5) | ||
(%) | 70 | (%) | OS events, n (%): 176 (66%) | ||
60 | 60 | ||||
probability | 60 | probability | |||
40 | 50 | 40 | |||
OS | 40 | OS | |||
30 | 20 | ||||
20 | 20 | ||||
Enhertu (n = 261) | 10 | Enhertu (n = 331) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
0 | T-DM1 (n = 263) | 0 | TPC (n = 163) | 0 | |||||||||||||||||||||||||||||||||||||||||||||||||||
0 2 4 6 8 10 12 14 | 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 | 0 | 2 | 4 | 6 | 8 | 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 | 0 | 3 | 6 | 9 | 12 | 15 | 18 | 21 | 24 | 27 | 30 | 33 | ||||||||||||||||||||||||||||||||||||
Time, months | Time from first dose (months) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Time, months |
DESTINY-Breast06(HER2-low/ultra-low) - statistically significant, clinically meaningful improvement in PFS5
1. Hurvitz SA et al. Lancet. 2023 Jan 14;401(10371):105-117. 2. Modi S et al. N Engl J Med. 2022 Jul 7;387(1):9-20. 3. Meric-Bernstam F et al. J Clin Oncol. 2024 Jan 1;42(1):47-58. 4. Solid tumours including endometrial, cervical, ovarian, bladder, | |
BTC, pancreatic. 5. AstraZeneca press release. https://www.astrazeneca.com/media-centre/press-releases/2024/enhertu-improved-pfs-in-her2-low-and-ultralow.html. Accessed May 2024. Acronym definitions can be found in Glossary. | Investor Day • 2024 |
8 Collaboration partners: Daiichi Sankyo (Enhertu). |
Dato-DXd - potential to displace chemotherapy in NSCLC and breast cancer
TROPION-Lung011
2L+ Non-squamous NSCLC
0.63 PFS HR
Dato-DXd docetaxel
PFS probability (%)
TROPION-Breast012 | |||||||||||||||||||||||||||||||||||
2-3L HR+ HER2- breast cancer | |||||||||||||||||||||||||||||||||||
100 | 0.64 PFS HR | ||||||||||||||||||||||||||||||||||
80 | |||||||||||||||||||||||||||||||||||
60
40
20
Dato-DXd | |||||
0 | ICC | ||||
3 | 6 | 9 | 12 | 15 | |
0 | |||||
Time from randomisation (months) |
First TROP2 ADC in NSCLC to demonstrate statistically significant, clinically meaningful outcomes in Phase III
1. Lisberg A et al. Abstract LBA12 presented at European Society of Medical Oncology 2023. 2. Bardia A et al. Abstract LBA11 presented at European Society of Medical Oncology 2023. Acronym definitions can be found in Glossary. 9 Collaboration partners: Daiichi Sankyo (Dato-DXd).
Investor Day • 2024
Next-generation bispecifics - going beyond PD-1/PD-L1 inhibitors to establish new IO segments
rilvegostomig (PD-1/TIGIT) | volrustomig (PD-1/CTLA-4) |
Increasing PD-1 activity in | Driving survival in CTLA-4 |
PD-(L)1 sensitive tumours | sensitive tumours |
Acronym definitions can be found in Glossary.
10 Collaboration partners: Compugen (rilvegostomig).
Investor Day • 2024
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
AstraZeneca plc published this content on 21 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 May 2024 14:02:02 UTC.