Roche Holding Ltd · SIX:RO
Roche — EHA Annual Meeting 2023 Virtual IR event
37 slides from Roche's conference presentation, Jun 12, 2023
Slide 1: Slide 1
Slide 2: EHA Annual Meeting 2023: Crovalimab in hematology and nephrology
EHA Annual Meeting 2023 Crovalimab in hematology and nephrology Virtual IR event 12th June 2023
Slide 3: Forward-looking statements
This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, str
Slide 4: Welcome
Welcome Bruno Eschli | Head of Investor Relations
Slide 5: Agenda
Agenda Welcome Bruno Eschli, Head of Investor Relations Hematology franchise strategy and crovalimab development program Peter Ahnesorg, Franchise Head Hematology, Global Product Strategy Key data at EHA 2023 ● Crovalimab in PNH (Ph III COMMODORE 2/1) Prof. Alexander Röth, MD, West German Cancer Cen
Slide 6: 2023: Key late-stage news flow
2023: Key late-stage news flow* Additional 2023 news flow: ● Fenebrutinib: Positive Ph II (FENopta) results in RMS ● Tiragolumab + Tecentriq + Avastin: Positive Ph I/II (MORPHEUS) results in uHCC Angiogenesis 2023 Roche ESG Day Roche Pharma Day Roche Digitalization Day ASH 2023 Virtual Virtual Londo
Slide 7: Hematology franchise strategy and crovalimab development program
Hematology franchise strategy and crovalimab development program Peter Ahnesorg | Franchise Head Hematology, Global Product Strategy 7
Slide 8: Roche a leader in non-malignant and malignant hematology
Roche a leader in non-malignant and malignant hematology Present in different diseases with 7 medicines on the market ● Established leader in DLBCL, FL, CLL and hemophilia A Investing across growth & new ● Expansion potential in malignant hematology: AML, MM, MDS, MCL indications ● Expansion potenti
Slide 9: Hematology market expected to grow strongly
Hematology market expected to grow strongly Broad hematology portfolio: 18 molecules in 10+ diseases marketed/in development Roche’s hematology portfolio is well positioned in a fast growing market 102 † 17 englumafusp alfa (CD19-4-1BBL), DLBCL CD19 x CD28 +77% 9 FL 12 CLL * 58 5 cevostamab (FcRH5 x
Slide 10: CD20 x CD3 development program moving into earlier lines
CD20 x CD3 development program moving into earlier lines First launches for Lunsumio and Columvi in 3L + FL/DLBCL achieved Product profile Key clinical trials Regimen Indication Ph I Ph II Ph III • High CR rate and durable responses Lunsumio 3L+ FL US/EU approved • Favorable tolerability with low gr
Slide 11: Crovalimab: Expanding program in complement-mediated diseases
Crovalimab: Expanding program in complement-mediated diseases Global filing in the initial indication PNH expected for H1 2023 Crovalimab (anti-C5 recycling Ab) Broad development program in complement mediated diseases • Uses Chugai’s recycling antibody technology • Ph III (COMMODORE 2/1) in PNH res
Slide 12: Crovalimab in PNH: Key challenges remain with current SoC
Crovalimab in PNH: Key challenges remain with current SoC Life-long treatment and high disease burden require extra attention to patient QoL Disease overview Disease burden Unmet needs Fatigue (96%) Dysphagia (41%) Anaemia (89%) Inconvenient administration Dyspnea (66%) Hypertension (47%) Abdominal
Slide 13: Crovalimab in PNH: Positive results throughout Ph III program
Crovalimab in PNH: Positive results throughout Ph III program Improved dosing convenience reflected in strong patient preference for crovalimab Development program in PNH Improved dosing convenience and patient preference Dosing convenience Patient preference* Ph I Ph II Ph III Status COMPOSER Easy
Slide 14: Crovalimab in aHUS: Addressing key unmet needs in a rare disease
Crovalimab in aHUS: Addressing key unmet needs in a rare disease Improved administration, access and new potential option for poor responders Disease overview Disease burden Unmet needs 50% of patients develop ESRD Inconvenient IV administration <2 years age of onset for half of pts. Poor response i
Slide 15: Crovalimab in SCD: Manage and prevent vaso-occlusive episodes
Crovalimab in SCD: Manage and prevent vaso-occlusive episodes VOEs are the main cause for emergency department visits in SCD patients Disease overview Disease burden Unmet needs VOEs - Episodes of severe pain Treatment goals for patients with SCD Most common pain sites in SCD5 Key characteristics (%
Slide 16: Crovalimab in LN: Second MoA in development following Gazyva
Crovalimab in LN: Second MoA in development following Gazyva Gazyva Ph III reading out in 2024, with first and best in class potential in LN Disease overview Unmet needs Development program Cortex 25% of patients develop ESRD Ph I Ph II Ph III Self-DNA Gazyva REGENCY Inflamed glomeruli ~40 years mea
Slide 17: Key data at EHA: Crovalimab data in PNH
Key data at EHA Crovalimab data in PNH (Ph III COMMODORE 2/1) Prof. Alexander Röth, MD | West German Cancer Center, University Hospital Essen 17
Slide 18: Crovalimab is a novel, humanized antibody against C5
Crovalimab is a novel, humanized antibody against C5 that binds a different epitope than eculizumab or ravulizumab Crovalimab mechanism of action 1. High-affinity binding1,2,3 ● Crovalimab is engineered to optimize binding of C5 in the plasma through affinity maturation 2/3. Preferential antibody up
Slide 19: Clinical trial program evaluating crovalimab in over 400 people with PNH
A rigorous clinical trial program is evaluating crovalimab in over 400 people with PNH Phase I/II Phase III Phase III Phase III COMPOSER COMMODORE 3 COMMODORE 2 COMMODORE 1 4-part adaptive study in Single-arm study in Randomized study Randomized study in C5 inhibitor-naive and C5 inhibitor-naive in
Slide 20: Crovalimab non-inferior to eculizumab in hemolysis control
Crovalimab is non-inferior to eculizumab in the co-primary endpoint of hemolysis control in naive patients (COMMODORE 2) Patients who switched from eculizumab to crovalimab maintained disease control (COMMODORE 1) COMMODORE 21 COMMODORE 12 C5 inhibitor naive patients Switch patients Crovalimab Eculi
Slide 21: Crovalimab non-inferior in hemolysis control (COMMODORE 2)
Crovalimab is non-inferior to eculizumab in the co-primary endpoint of hemolysis control in naive patients (COMMODORE 2) COMMODORE 21: Proportion of patients with COMMODORE 21: Mean normalized LDH central LDH ≤1.5×ULN Clinical cutoff: Nov 16, 2022. Error bars represent 95% CIs. LDH=Lactate dehydroge
Slide 22: Crovalimab non-inferior in transfusion avoidance
Crovalimab is non-inferior to eculizumab in the co-primary endpoint of transfusion avoidance in naive patients (COMMODORE 2) Patients who switched from eculizumab to crovalimab maintained disease control (COMMODORE 1) COMMODORE 21 COMMODORE 12 C5 inhibitor naive patients Switch patients Crovalimab E
Slide 23: Non-inferior for breakthrough hemolysis
Crovalimab is non-inferior to eculizumab for the secondary endpoint of breakthrough hemolysis in naive patients (COMMODORE 2) Patients who switched from eculizumab to crovalimab maintained disease control (COMMODORE 1) COMMODORE 21 COMMODORE 12 C5 inhibitor naive patients Switch patients Crovalimab
Slide 24: Non-inferior for hemoglobin stabilization
Crovalimab is non-inferior to eculizumab for the secondary endpoint of hemoglobin stabilization in naive patients (COMMODORE 2) Patients who switched from eculizumab to crovalimab maintained disease control (COMMODORE 1) COMMODORE 21 COMMODORE 12 C5 inhibitor naive patients Switch patients Crovalima
Slide 25: Clinically meaningful improvement in FACIT-Fatigue
Clinically meaningful improvement in FACIT-Fatigue in both arms; numerically greater improvement with crovalimab in COMMODORE 2 Patients switching from eculizumab to crovalimab maintained baseline fatigue values (COMMODORE 1) COMMODORE 2: FACIT-Fatiguea Normative population mean: 43.5–46.6 COMMODORE
Slide 26: Crovalimab well tolerated in COMMODORE 2 and 1
Crovalimab was well tolerated during the primary treatment period of COMMODORE 2 and COMMODORE 1 COMMODORE 21 COMMODORE 12 naive patients switch patients Crovalimab Eculizumab Crovalimab Eculizumab (N=135) (N=69) (N=44) (N=42) 19.7 22.0 20.1 22.1 Treatment duration, median (range), weeksa (0.1–23.1)
Slide 27: Over 80% of participants preferred crovalimab over eculizumab
More than 80% of COMMODORE 1 and 2 participants assessed for treatment preference, preferred crovalimab over eculizumab* Exploratory analysis of treatment preference in COMMODORE 1 and 2 patientsa Patients randomized to eculizumab who switched to crovalimab in the extension period Patients randomize
Slide 28: COMMODORE 1 and COMMODORE 2: Conclusions
COMMODORE 1 and COMMODORE 2: Conclusions • COMMODORE 2 met its co-primary endpoints, demonstrating non-inferiority vs eculizumab for hemolysis control and transfusion avoidance – Crovalimab is also non-inferior to eculizumab for breakthrough hemolysis and hemoglobin stabilization – Clinically meanin
Slide 29: Nephrology franchise strategy
Nephrology franchise strategy Jay Garg, MD | Global Development Head Nephrology and Rheumatology 29
Slide 30: Roche's strategy to tackle kidney disease
Roche’s strategy to tackle kidney disease Founded in expanding portfolio in immune-mediated kidney disease Roche’s vision and strategy to cure kidney disease Portfolio Partnerships Solutions Access Barriers to treatment are Roche has a leading Close partnerships with Roche aims at providing signific
Slide 31: Building a portfolio to address the growing burden of kidney disease
Building a portfolio to address the growing burden of kidney disease Seven pivotal trials currently ongoing in immune-mediated nephropathies Kidney disease is a global growing burden Roche portfolio spans established and late stage products Indication Molecule Ph I Ph II Ph III Approved Prevention o
Slide 32: SLE: Two approaches to B cell depletion in clinical development
SLE: Two approaches to B cell depletion in clinical development B cells represent a potential new drug target as they are central to SLE pathogenesis Enhanced B cell depletion may lead to improved clinical Gazyva & Lunsumio in SLE responses in SLE Gazyva: Type II anti-CD20 mAb Lunsumio: Anti-CD20 bi
Slide 33: LN: Gazyva Ph III data expected in 2024
LN: Gazyva Ph III data expected in 2024 Ph I for crovalimab (anti-C5 recycling Ab) initiated in LN Ph II (NOBILITY) results for Gazyva in LN1 Gazyva and crovalimab development programs: Complete renal response Overall renal response Ph III (REGENCY) trial design of Gazyva in LN: p<0.05 p<0.01 Gazyva
Slide 34: MN & INS: Complementary indications of the Gazyva program
MN & INS: Complementary indications of the Gazyva program Gazyva with best in disease therapy potential for MN and childhood onset INS Gazyva in childhood onset idiopathic nephrotic Gazyva in membranous nephropathy (MN) syndrome (INS) Diffuse thickening of glomerular Ph III (MAJESTY) study design Di
Slide 35: aHUS: 50% of patients progressing to end-stage renal disease
aHUS: 50% of patients progressing to end-stage renal disease Ph III trials of crovalimab in aHUS on-going Disease overview Development program of crovalimab in aHUS Ph III trial design Ph III (COMMUTE-a) in adults Ph III (COMMUTE-p) in pediatrics crovalimab intravenous Naïve Cohort Naïve Cohort crov
Slide 36: IgAN: Ph III ASO FB trial initiated in Q2 2023
IgAN: Ph III ASO FB trial initiated in Q2 2023 Positive Ph II results in UPCR presented at ASN 2022 Complement factor B in IgA Study program of ASO FB in IgA nephropathy nephropathy (IgAN) Accumulation of Complement Mesangial Early Ph II results3 Ph III (IMAGINATION) trial design immune complexes ac
Slide 37: Doing now what patients need next
Doing now what patients need next