Roche Holding Ltd · SIX:RO
Roche — Investor Presentation (2023)
26 slides from Roche's investor presentation, 2023
Slide 1: VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx
VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx Elevating hope for lower expression MC--13280 1
Slide 2: Agenda
1. Product overview 2. Unmet medical need Agenda 3. Significance of a clinically validated assay 4. Product versions and intended uses MC--13280 2
Slide 3: Product overview
Product overview MC--13280 3
Slide 4: Executive summary: Product overview
Executive summary Product overview VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx Platform BenchMark ULTRA, XT, and GX Sample preparation/Amplification/Detection ultraView Universal DAB Detection Kit Core software VSS version 12.3 or higher Assay script software ULTRA VENTANA HER2 4B5,
Slide 5: Executive summary: Intended use
Executive summary Product overview VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx Intended use The VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx is a rabbit monoclonal antibody intended for laboratory use for the semi-quantitative detection of HER2 antigen in sections of fo
Slide 6: Product claims
Product claims Features and benefits Only CE-IVD marked test to screen metastatic breast cancer (mBC) patients for HER2-low status (up to 50% of mBC patients) who previously did not qualify for HER2-targeted therapies Only assay to have up to 4 HER2-targeted therapies on label Potential to expand to
Slide 7: Unmet need
VENTANA Jnmet m MC--13280
Slide 8: Unmet medical need
Unmet medical need Top unmet needs in breast cancer today ● Effective targeted therapies for triple-negative breast cancer (TNBC) ● Identification of novel biomarkers predictive of benefit to therapy ● Treatment of brain metastases ● More-efficacious treatments for advanced/metastatic disease ● Trea
Slide 9: Disease overview: breast cancer survival rates
Unmet medical need Disease overview Breast cancer survival rates1 close to about about about 100% 93% 72% 22% Stage 0 or Stage 1 Stage 2 Stage 3 Stage 4 The 5-year relative survival rate for For women with stage 2 breast The 5-year relative survival rate for Metastatic, or stage 4 breast women with
Slide 10: Current treatment overview for advanced metastatic disease
Unmet medical need Current breast disease treatment overview for advanced metastatic disease Establish HER2 status, HR status, site and extent of disease, Diagnosis of recurrent/metastatic breast cancer disease-free interval, age, menopausal status DB04/HER2 Low HER2-positive HER2-negative First-lin
Slide 11: Disease overview
Unmet medical need Disease overview One in eight women will get Breast cancer is Metastatic breast Breast cancer is breast cancer diagnosed every cancer ends 110 the 2nd leading 29 seconds lives a day cause of cancer around the world, death among and in the U.S. women in the U.S. it’s every 2 One in
Slide 12: Drug overview – trastuzumab deruxtecan/ENHERTU
Unmet medical need Drug overview – trastuzumab deruxtecan/ENHERTU DS-8201 Antibody Drug Conjugate ● Trastuzumab deruxtecan (T-DXd) is an anti-HER2 antibody–drug conjugate with a novel topoisomerase I inhibitor manufactured by Daiichi Sankyo Proprietary Drug-Linker HER2 Antibody ● T-DXd exhibited a p
Slide 13: ENHERTU to change treatment paradigm
Unmet medical need ENHERTU to change treatment paradigm for large segment of breast cancer Current paradigm Future paradigm (after DESTINY-Breast04) ‘HER2 positive’ HER2+ HER2+ HR+/ IHC1+/ HER2 Low 2+ ISH-1 Population for Currently HR+/ DESTINY-Breast04 ‘HER2 negative’ >50% of HER2- HER2-low all BC
Slide 14: DESTINY-Breast04 study design
Unmet medical need DESTINY-Breast04: Phase 3 study of ENHERTU compared to existing 2L & 3L HER2-negative monotherapies for HER2- low breast cancer Primary endpoints ENHERTU PFS (BICR) in HR+ Key eligibility criteria 5.4 mg/kg ● ● HER2-low (IHC 1+ or IHC 2 +/ISH-) n=360 ● Unresectable or metastatic K
Slide 15: ENHERTU efficacy: PFS in HR-positive cohort
Unmet medical need ENHERTU: efficacy data Progression-free survival in hormone receptor Positive cohort No. of progression-free survival (95% Cl) mo 10 331 10.1 (9.5-11.5) 0.8 163 5.4 (4.4-7.1) 0.6 Trastuzumab 5 0.2 | Hazard ratio for progression 0.4 deruxtecan Cl, 0.40-0.64) P<0.001 or death, 0.0 0
Slide 16: ENHERTU efficacy: PFS among all patients
Unmet medical need ENHERTU: efficacy data Progression-free survival among all patients No. of patients Median progression-free survival (95% Cl) mo 1° 373 9.9 (9.0-11.3) 0.8 184 5.1(4.2-6.8) = 0.6 0.4 Trastuzumab deruxtecan a 0.2 for progression or dea Physician’s choice Cl, 0.40-0.63) P<0.001 67 8
Slide 17: ENHERTU efficacy: overall survival in HR-positive cohort
Unmet medical need ENHERTU: efficacy data Overall survivalin hormone receptor Positive cohort No. of patients Median overall survival (95% Cl) mo 1.0 331 23.9 (20.8-24.8) overallsurvival Probability of 0.8 163 0.6 Trastuzumab deruxtecan 0.4 0.2 | Hazard ratio for death, Physician’s choice 0.0 Cl, 0.
Slide 18: ENHERTU efficacy: overall survival all patients
Unmet medical need ENHERTU: efficacy data Overall all patients No. of overall survival (95% Cl) mo 1.0 373 23.4 (20.0-24.8) overall survival Probability of 0.8 184 16.8 (14.5-20.0) 0.6 Trastuzumab deruxtecan 0.4 0.2 Hazard ratio for death, Physician’s choice 0.0 0.64 (95% Cl, 0.49-0.84) P=0.001 012
Slide 19: Roche HER2 (4B5) assay detects HER2 across broad spectrum
Unmet medical need Roche HER2 (4B5) assay* now detects the HER2 protein across the broad spectrum (0, 1+, 2+, 3+) HER2 (4B5) IHC Assay IHC 0 IHC 1+ IHC 2+ IHC 3+ Reflex test to assess gene amplification Unamplified Amplified Not eligible for Eligible for therapies targeting the Eligible for HER2 HER
Slide 20: Significance of a clinically validated study
Significance of a clinically validated study MC--13280 20
Slide 21: Significance of a clinically validated assay
Significance of a clinically validated assay Using non-clinically validated tests means treating patients without clinical evidence of benefit or acceptable safety profile Head to head comparison of IHC assays Assay comparison test Conclusion depends on purpose of comparison Clinically LDT/Non-clini
Slide 22: Only clinically validated test to assess HER2-low status
Significance of a clinically validated assay The Roche HER2 (4B5) assay* is the only clinically validated test to accurately assess HER2-low status in order to select breast cancer patients eligible for trastuzumab deruxtecan therapy DESTINY Breast04 study participants experienced 11.5% greater inci
Slide 23: Product versions and intended uses
Product versions and intended uses MC--13280 23
Slide 24: Product versions and their intended uses (EU)
Product versions and their intended uses (EU) Roche HER2 (4B5) assay in the EU On-market part numbers used in the EU NEW part number upon CE launch and CE-IVD mark of HER2 Low Product name PATHWAY anti-HER-2/neu (4B5) Rabbit VENTANA anti-HER2/neu (4B5) VENTANA HER2 (4B5) Rabbit Monoclonal Monoclonal
Slide 25: Thank you
Thank you for your attention VENTANA, BENCHMARK, OPTIVIEW and PATHWAY are trademarks of Roche. All other trademarks are the property of their respective owners. © 2023 Roche MC–13280 diagnostics.roche.com MC--13280 This presentation is our intellectual property. Without our written consent, it shall
Slide 26: Signature Page for MC--13280 v1.0
Signature Page for MC--13280 v1.0 Regulatory Approval Larissa Lima-Znaidi (Larissa.Lima-Znaidi@roche- diagnostics.com) on behalf of Deanna Koon Regulatory Approval 11-Dec-2023 19:43:19 GMT+0000 Signature Page for MC--13280 v1.0 MC--13280