Astrazeneca Plc · LSE:AZN
Astrazeneca — San Antonio Breast Cancer Symposium (SABCS) 2022
42 slides from Astrazeneca's conference presentation, Dec 8, 2022
Slide 1: Investor science conference call: San Antonio Breast Cancer Symposium (SABCS) 2022
Investor science conference call: San Antonio Breast Cancer Symposium (SABCS) 2022 Conference call for investors and analysts 08 December 2022
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: Speakers and Q&A Panel
Dr. Nicholas Turner Susan Galbraith Professor, Institute of Executive Vice President, Cancer Research, Royal Oncology Research and Marsden Hospital, London Development Speakers and Dave Fredrickson Cristian Massacesi Q&A Panel Executive Vice President, Chief Oncology Oncology Business Development Of
Slide 4: Agenda: SABCS 2022
Agenda: SABCS 2022 Introduction Susan Galbraith, EVP Oncology R&D Dr. Nicholas Turner, Professor, Institute of capivasertib CAPItello-291 Cancer Research, Royal Marsden Hospital, London Cristian Massacesi, Chief Oncology camizestrant SERENA-2 Development Officer and CMO Other key data @ SABCS Susan
Slide 5: Introduction
Introduction Susan Galbraith EVP, Oncology R&D
Slide 6: AstraZeneca @ SABCS
56 accepted abstracts Key data highlights across our portfolio presented at SABCS 2022 AstraZeneca @ • 5 commercial medicines • Enhertu DESTINY-Breast03 SABCS ― Enhertu, Lynparza, Imfinzi, (HER2-high) Key data un-gates Faslodex, Koselugo • Enhertu DESTINY-Breast02 • 7 pipeline molecules (HER2-high)
Slide 7: AstraZeneca at SABCS 2022: key data advances strategic ambitions in breast cancer
AstraZeneca at SABCS 2022 Key data advances our strategic ambitions in breast cancer HER2-high Setting new standards Establishing and gBRCA Reshaping the Redefining the treatment HR+ of care in HER2-high expanding beyond treatment of HR+ and understanding of TNBC mBC gBRCA • Enhertu as the foundatio
Slide 8: AstraZeneca: Leaders in Breast Cancer treatment
AstraZeneca: Leaders in Breast Cancer treatment Innovative portfolio of medicines, built on foundational history Future state: Continuing to transform Nolvadex first the treatment paradigm 1960s 2010s Lynparza approved in BRCAm synthesized; list of HER2-low mBC • Next-generation oral SERD (camizestr
Slide 9: Reshaping HR+ Breast Cancer
Reshaping HR+ Breast Cancer Camizestrant ngSERD, capivasertib extending ET in ER-driven disease Metastatic Early 1L mBC 1L 2L 3L+ HER2-low HR+ Int/High ADCs acquired camizestrant (SERENA-4) capivasertib (CAPItello-291) ER-driven c.85% of HR+ mBC Risk potential camizestrant (23%) resistance to replac
Slide 10: capivasertib CAPItello-291 Phase III trial
capivasertib CAPItello-291 Phase III trial Dr Nicholas Turner The Institute of Cancer Research, London, and Principal Investigator
Slide 11: CAPItello-291: trial overview
CAPItello-291: trial overview Patients with HR+/HER2– aBC 400 mg twice daily, 4 days Dual primary endpoints Capivasertib on, 3 days off • Men and pre-/post-menopausal women PFS by investigator assessment • Recurrence or progression while on or • Overall <12 months from end of adjuvant AI, 500 mg: cy
Slide 12: CAPItello-291: dual-primary endpoint, overall population
CAPItello-291: dual-primary endpoint Investigator-assessed PFS in the overall population Capivasertib + Placebo + 100 fulvestrant (N=355) fulvestrant (N=353) PFS events 258 293 Progression-free survival (%) 90 80 Median PFS 7.2 (5.5–7.4) 3.6 (2.8–3.7) 70 (95% CI); months 60 Adjusted HR (95% CI): 0.6
Slide 13: CAPItello-291: dual-primary endpoint, AKT pathway-altered population
CAPItello-291: dual-primary endpoint Investigator-assessed PFS in the AKT pathway-altered population Capivasertib + Placebo + 100 fulvestrant (N=155) fulvestrant (N=134) PFS events 121 115 Progression-free survival (%) 90 80 Median PFS 7.3 (5.5–9.0) 3.1 (2.0–3.7) 70 (95% CI); months 60 Adjusted HR (
Slide 14: CAPItello-291: PFS in the non-altered population
CAPItello-291: investigator-assessed PFS in the non-altered population (including unknown1) 100 Capivasertib + Placebo + Progression-free survival (%) 90 fulvestrant (N=200) fulvestrant (N=219) 80 PFS events 137 178 70 Median PFS 7.2 (4.5–7.4) 3.7 (3.0–5.0) (95% CI); months 60 HR (95% CI): 0.70 (0.5
Slide 15: CAPItello-291: overall survival data at 28% maturity
CAPItello-291: overall survival data at 28% maturity *0.01% alpha penalty assigned to OS analyses of no detriment. Formal analysis not prespecified. HR was estimated using the Cox proportional hazard model stratified by the presence of liver metastases (overall population only) and 15 prior use of C
Slide 16: CAPItello-291: investigator-assessed PFS by subgroup
CAPItello-291: investigator-assessed PFS by subgroup (overall population) Prior treatments – overall population Characteristic Capivasertib + Placebo + fulvestrant fulvestrant (N=355) (N=353) Prior endocrine therapy 0 40 (11.3) 54 (15.3) for ABC; 1 286 (80.6) 252 (71.4) n (%) 2 29 (8.2) 47 (13.3) Pr
Slide 17: CAPItello-291: safety summary
CAPItello-291: safety summary Adverse event and safety profile comparable in AKT pathway-altered population Adverse events (>10% of patients) – overall population Safety summary – overall population n (%) Capivasertib Placebo + + fulvestrant fulvestrant (N=355) (n=350) Any adverse event 343 (96.6) 2
Slide 18: CAPItello-291: key takeaways and conclusions
CAPItello-291: key takeaways and conclusions • Capivasertib plus fulvestrant provides a statistically significant and clinically meaningful improvement in PFS in the overall and the AKT pathway-altered population (dual primary) • Benefit from capivasertib was consistent across key clinically relevan
Slide 19: camizestrant SERENA-2 Phase II trial
camizestrant SERENA-2 Phase II trial Cristian Massacesi CDO Oncology and CMO
Slide 20: SERENA-2: trial design and inclusion criteria
SERENA-2: trial design and inclusion criteria A randomised, multi-dose Phase II trial of camizestrant (75mg, 150mg) vs. fulvestrant No formal analyses of camizestrant camizestrant 300 mg (n=20) 300 mg versus fulvestrant were (CSP v5 amendment: 16Dec20) conducted as enrolment to this arm was stopped
Slide 21: SERENA-2: key baseline characteristics
SERENA-2: key baseline characteristics C 75 C 150 F Total C 75 C 150 F Total (n=74) (n=73) (n=73) (n=240) (n=74) (n=73) (n=73) (n=240) Age (median, range) 61.0 (37-89) 60.0 (42-84) 60.0 (35-84) 60.0 (35-89) CT adjuvant, Y (%) 54.1 53.4 52.1 52.1 CT in ABC, Y (%) 21.6 12.3 26.0 19.2 Gender,
Slide 22: SERENA-2: primary endpoint
SERENA-2: primary endpoint Progression free survival by investigator assessment C 75 (n=74) C 150 (n=73) F (n=73) 1.0 Median duration 16.6 16.6 17.4 of follow-up, months Events [n (%)] 50 (67.6) 51(69.9) 58 (79.5) 0.8 Median PFS, months 7.2 7.7 3.7 (90% CI) (3.7-10.9) (5.5-12.9) (2.0-6.0) Adjusted H
Slide 23: SERENA-2: PFS by prior use of CDK4/6 inhibitors
SERENA-2: PFS in patients by prior use of CDK4/6 inhibitors aHRs adjusted for liver/lung metastases aHRs adjusted for liver/lung metastases In the sub-population of patients previously treated with CDK4/6i + endocrine therapy, camizestrant at both doses produces a clinically meaningful improvement i
Slide 24: SERENA-2: PFS by lung and/or liver metastases
SERENA-2: PFS in patients by lung and/or liver metastases aHRs adjusted for prior use of CDK4/6i aHRs adjusted for prior use of CDK4/6i In the sub-population of patients with lung and/or liver metastases, camizestrant at both doses produces a clinically meaningful improvement in PFS over fulvestrant
Slide 25: SERENA-2: PFS by detectable ESR1m at baseline
SERENA-2: PFS in patients by detectable ESR1m at baseline aHRs adjusted for prior use of CDK4/6i and aHRs adjusted for prior use of CDK4/6i and liver/lung metastases liver/lung metastases In the sub-population of patients with detectable ESR1m at baseline, camizestrant at both doses produces a clini
Slide 26: SERENA-2: PFS by ER-driven disease
SERENA-2: PFS in patients by ER-driven disease1 aHRs adjusted for prior use of CDK4/6i and aHRs adjusted for prior use of CDK4/6i and liver/lung metastases liver/lung metastases • In the subgroup of patients with evidence of ER-driven disease (71.3% of overall population), both 75 mg (HR 0.53) and 1
Slide 27: SERENA-2: patient level safety summary
SERENA-2: patient level safety summary C 75 (n=74) C 150 (n=73) C 300 (n=20) F 500 (n=73) Total duration, months, mean (SD) 8.27 (6.59) 8.91 (6.78) 9.26 (8.19) 7.34 (6.09) Any treatment-emergent AE (TEAE), n (%) 57 (77.0) 66 (90.4) 19 (95.0) 50 (68.5) Any treatment-related AE (TRAE), n
Slide 28: SERENA-2: all treatment-emergent adverse events
SERENA-2: all treatment-emergent adverse events C 75 (n=74) C 150 (n=73) C 300 (n=20) F 500 (n=73) AE, n (%) All grades Grade ≥3 All grades Grade ≥3 All grades Grade ≥3 All grades Grade ≥3 Any AE 57 (77.0) 9 (12.2) 66 (90.4) 16 (21.9) 19 (95.0) 3 (15) 50 (68.5) 10 (13.7) Photopsia 9 (12.2)
Slide 29: SERENA-2: conclusions
SERENA-2: conclusions • SERENA-2 met its primary objective: camizestrant at both 75 and 150 mg doses improves PFS over fulvestrant in post-menopausal women with ER+/HER2- ABC • Camizestrant delivers statistically significant and clinically meaningful PFS benefit at both 75 and 150 mg doses over ful
Slide 30: Other key data @ SABCS
Other key data @ SABCS Susan Galbraith EVP, Oncology R&D
Slide 31: Enhertu DESTINY-Breast03
Enhertu DESTINY-Breast03 Reinforces Enhertu as established standard of care in 2L HER2-high Key secondary endpoint: overall survival Clinically meaningful, statistically significant improvement over T-DM1 • mPFS with Enhertu 4x longer than T-DM1 (28.8m vs. 6.8m) ― CLEOPATRA mPFS 18.7m in 1L1 • 78.5%
Slide 32: Dato-DXd
Dato-DXd Reinforcing potential of next-gen ADCs to replace chemo across HR+ and TNBC Potential in heavily pre-treated HR+/HER2- Potential to address advanced TNBC Phase I TROPION-PanTumor01 Phase I TROPION-PanTumor01 • Encouraging, durable efficacy in heavily pre-treated patients (95% • mDOR 16.8 mo
Slide 33: Advancing the treatment paradigm in breast cancer
Advancing the treatment paradigm in breast cancer Dave Fredrickson EVP, Oncology Business
Slide 34: Addressing the significant unmet need in breast cancer
Addressing the significant unmet need in breast cancer #1 2.3m 685,000 most diagnosed cancer newly identified breast deaths from breast cancer globally1 cancer cases diagnosed each year globally2 each year globally2 34 1. breastcancer.org, statistics specific to women in US; 2. GLOBOCAN 2020.
Slide 35: Reshaping HR+ Breast Cancer
Reshaping HR+ Breast Cancer Camizestrant ngSERD, capivasertib extending ET in ER-driven disease Metastatic Early 1L mBC 1L 2L 3L+ HER2-low HR+ SERENA-2 Phase II in 2L reinforces Int/High ADCs confidence in ongoing Phase III acquired capivasertib (CAPItello-291) ER-driven c.85% of HR+ mBC Risk potent
Slide 36: CAPItello-291: potential new standard of care
CAPItello-291: potential new standard of care Capivasertib first-in-class AKT inhibitor, addresses unmet need in 2L+ mBC Patient outcomes in 2L+ mBC remain poor Capivasertib addresses key unmet need 75,000 • CAPItello-291 overcomes key mechanism of ET + patients diagnosed each year with metastatic C
Slide 37: Enhertu: DESTINY-Breast03 OS data supports market leader in 2L HER2-high
Enhertu DESTINY-Breast03 OS data supports Enhertu as market leader in 2L HER2-high Accelerated adoption in 2L HER2-high DESTINY-Breast03 • OS data shows Enhertu significantly reduced risk of 12% 15% 12% death by 36% (HR 0.64) 9% 10% 10% • Rapid adoption in 2L HER2-high patients following 12% 10% 13%
Slide 38: Q&A session
AstraZeneca Q&A session
Slide 39: Q&A Panel
Dr Nicholas Turner Susan Galbraith Professor, Institute of Executive Vice President, Cancer Research, Royal Oncology Research and Marsden Hospital, London Development Dave Fredrickson Cristian Massacesi Q&A Panel Executive Vice President, Chief Oncology Oncology Business Development Officer and Chie
Slide 40: Appendix
AstraZeneca Appendix
Slide 41: CAPItello-291: prior treatments
CAPItello-291: prior treatments Overall population AKT pathway-altered population Characteristic Capivasertib + Placebo + Capivasertib + Placebo + fulvestrant (N=355) fulvestrant (N=353) fulvestrant (N=155) fulvestrant (N=134) Prior endocrine 0 40 (11.3) 54 (15.3) 14 (9.0) 20 (14.9) therapy for ABC;
Slide 42: Use of AstraZeneca slides from conference calls and webcasts
Use of AstraZeneca slides from conference calls and webcasts 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 available to th
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