Roche Holding Ltd · SIX:RO
Roche — Investor Presentation (June 2024)
43 slides from Roche's investor presentation, Jun 16, 2024
Slide 1: Slide 1
Slide 2: Roche Hematology Virtual IR event 16 June 2024
Roche Hematology Virtual IR event 16 June 2024
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: Agenda
Agenda Introduction 13:00-13:05 Bruno Eschli, Head of Investor Relations STARGLO: Columvi-GemOx for R/R DLBCL - Results of a Global Randomized Ph III Trial 13:05-13:20 Jeremy Abramson, Massachusetts General Hospital Cancer Center, Boston, MA, USA Roche Bispecific Antibodies in NHL 13:20-13:30 Willia
Slide 5: Introduction
Introduction Bruno Eschli Head of Investor Relations
Slide 6: Roche's marketed portfolio in Hematology
Hematology Roche's marketed portfolio in Hematology Q1 2024 sales Hemlibra: • Global SoC in Hemophilia A with extensive real world data (YoY CER growth) 1.0 CHF bn (+8%) • Updated administration options in development Polivy: • Strong 1L DLBCL uptake in all major markets 0.3 CHF bn (+81%) • US patie
Slide 7: Broad hematology pipeline enabling novel combinations
Hematology Broad hematology pipeline enabling novel combinations A pioneer in bispecific antibodies and antibody drug conjugates (ADC) Ph I Ph II Ph III Registration englumafusp alfa RG6107 PiaSky (crovalimab) Columvi PiaSky (crovalimab)2 RG6076 RG6026 RG6107 PNH Heme tumors SCD 1L & 2L+ DLBCL, r/r
Slide 8: Hematology portfolio rejuvenation leads to growth rebound
Hematology Hematology portfolio rejuvenation leads to growth rebound Driven by a diverse portfolio and a broad pipeline Roche hematology franchise sales§ CHFm YoY CER growth Approved indications CAGR: +11% ** DLBCL & CLL FL & CLL Hemophilia A +14% +9% DLBCL -8% FL DLBCL Other rare blood *** disorder
Slide 9: Upcoming Roche IR events 2024
Upcoming Roche IR events 2024 Additional events driven by readouts Diagnostics Day Oncology/ASCO Hematology/EHA Ophthalmology/ASRS Pharma Day May 22 May 31 June 16 Jul 23 Sep 30 • Deep-dive into the • Oncology solid tumors • Ph III (STARGLO) • Ophthalmology • Update on Group & current product pipeli
Slide 10: STARGLO: Columvi-GemOx for R/R DLBCL - Results of a Global Randomized Ph III Trial
STARGLO: Columvi-GemOx for R/R DLBCL- Results of a Global Randomized Ph III Trial Jeremy Abramson Massachusetts General Hospital Cancer Center, Boston, MA, USA
Slide 11: Glofitamab plus GemOx for R/R DLBCL: Results of STARGLO
Glofitamab▼plus Gemcitabine and Oxaliplatin (Glofit-GemOx) for Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL): Results of a Global Randomized Phase III Trial (STARGLO) Jeremy S. Abramson,1 Matthew Ku,2 Mark Hertzberg,3 Christopher P. Fox,4 Charles Herbaux,5 Maria Fatima de la Cruz V
Slide 12: Disclosures: Jeremy S. Abramson
Disclosures: Jeremy S. Abramson • Consulting/advisory role: AbbVie, ADC Therapeutics, AstraZeneca, BeiGene, BMS, Cellectar, Caribou Biosciences, Celgene, Genentech, Inc., Gilead, Incyte, Interius, Janssen, Lilly, Novartis, F. Hoffmann-La Roche Ltd, Seagen, Takeda • Research funding: BMS, Cellectis,
Slide 13: Background
Background Glofitamab: CD20xCD3 T-cell engaging • Glofitamab is an off-the-shelf, fixed duration treatment bispecific antibody with 2:1 format for R/R LBCL1,2 – Engages and redirects T cells to eliminate malignant B cells High avidity binding to CD20 on B cells* • Phase I/II pivotal trial experience
Slide 14: STARGLO: randomized Phase III trial in ASCT-ineligible patients with R/R DLBCL
STARGLO: randomized Phase III trial in ASCT-ineligible patients with R/R DLBCL Glofit-GemOx (n=183) Glofitamab 30mg administered on Glofitamab plus gemcitabine and oxaliplatin* Day 1 of each cycle Step-up dosing in Cycle 1, Patients R/R DLBCL (N=274) 30mg administered on Day 1 from Cycle 2 onwards •
Slide 15: STARGLO: key endpoints and timing of analysis
STARGLO: key endpoints and timing of analysis Key endpoints Primary endpoint Overall survival Key secondary endpoints Progression-free survival by IRC assessment (hierarchical) Complete response rate by IRC assessment Duration of complete response by IRC assessment Safety endpoints Incidence, nature
Slide 16: Baseline characteristics
Baseline characteristics n (%), unless otherwise stated R-GemOx (n=91) Glofit-GemOx (n=183) Median (range) 68.0 (20–84) 68.0 (22–88) Age, years ≥65 years 56 (61.5) 116 (63.4) Sex Male 53 (58.2) 105 (57.4) Asian 51 (56.0) 86 (47.0) Black or African American 1 (1.1) 2 (1.1) Race White 33 (36.3) 82 (44
Slide 17: Primary endpoint: overall survival
Primary endpoint: overall survival Updated analysis R-GemOx Glofit-GemOx 100 (n=91) (n=183) Glofit-GemOx (n=183) R-GemOx (n=91) Primary analysis (median follow-up: 11.3 months) 80 Censored OS, median 9 (7.3–14.4) NE (13.8–NE) (95% CI); months 60 OS (%) HR (95% CI) 0.59 (0.40–0.89) 40 p-value* 0.011
Slide 18: Progression-free survival by IRC assessment
Progression-free survival by IRC assessment Updated analysis R-GemOx Glofit-GemOx 100 (n=91) (n=183) Glofit-GemOx (n=183) R-GemOx (n=91) Primary analysis (median follow-up: 9.6 months) 80 Censored PFS, median 3.3 (2.5–5.6) 12.1 (6.8–18.3) (95% CI); months 60 PFS (%) HR (95% CI) 0.37 (0.25–0.55) 40 p
Slide 19: Response rates by IRC assessment
Response rates by IRC assessment Response rates at the updated analysis 100 80 • 33.2% difference in CR rate ORR: 68.3% between treatment arms (95% CI: 19.7–44.5) Patients (%) PR: 9.8% 60 40 ORR: 40.7% • CR rate significantly better with PR: 15.4% Glofit-GemOx vs R-GemOx CR: 58.5% (descriptive p-val
Slide 20: OS in pre-specified subgroups: exploratory analysis
OS in pre-specified subgroups: exploratory analysis R-GemOx Glofit-GemOx (n=91) (n=183) Total Median Median 95% Wald Glofit-GemOx R-GemOx Baseline Risk Factors n n Events (Months) n Events (Months) HR CI better better All Patients 274 91 52 12.9 183 80 25.5 0.62 (0.44, 0.89) Sex Male 158 53 36 10.3
Slide 21: Safety profile summary
Safety profile summary n (%), unless otherwise stated R-GemOx (n=88) Glofit-GemOx (n=180) Number of cycles,* median (range) 4 (1–8) 11 (1–13) Any grade AEs 84 (95.5) 180 (100) Rituximab/glofitamab related 58 (65.9) 149 (82.8) Serious AEs 15 (17.0) 98 (54.4) Rituximab/glofitamab related 7 (8.0) 62 (3
Slide 22: Cytokine release syndrome
Cytokine release syndrome n (%) of patients with Glofit-GemOx ≥1 CRS AE* (Glofit exposed) n=172 CRS by cycle and grade in the updated analysis Any grade† 76 (44.2) 100 Grade 1 54 (31.4) Grade 3 90 Grade 2 18 (10.5) Grade 2 80 Grade 3 4 (2.3)‡ 70 Grade 1 Patients (%) Median time to CRS onset, hours (
Slide 23: Other AEs of interest
Other AEs of interest n (%) R-GemOx (n=88) Glofit-GemOx (n=180) Neurological AEs 35 (39.8) 105 (58.3) Grade ≥3 0 12 (6.7) ICANS NA* 4 (2.3)† Grade ≥3 NA* 1 (0.6) Tumor flare 0 1 (0.6) Grade ≥3 0 0 Infections 26 (29.5) 103 (57.2) Grade ≥3 11 (12.5) 42 (23.3) Neutropenia‡ 27 (30.7) 76 (42.2) Grade ≥3
Slide 24: COVID-19 AEs
COVID-19 AEs COVID-19 AE, n (%) R-GemOx (n=88) Glofit-GemOx (n=180) Any grade COVID-19 AE 8 (9.1) 33 (18.3) Grade ≥3 AE 2 (2.3) 11 (6.1) Grade 5 (fatal) AEs associated with COVID-19* 0 7 (3.9) AE leading to treatment discontinuation† 5 (5.7) 22 (12.2) COVID-19-related AE profile should be contextual
Slide 25: Conclusions
Conclusions • Fixed duration glofitamab added to GemOx demonstrated a statistically significant and clinically meaningful OS benefit in patients with R/R DLBCL, who were ineligible for ASCT – Median OS of 25.5 months with Glofit-GemOx compared with 12.9 months with R-GemOx (HR 0.62) – Glofit-GemOx i
Slide 26: Acknowledgments
Acknowledgments • The patients and their families • The study investigators, coordinators, and nurses • The sponsor, F. Hoffmann-La Roche Ltd Third-party medical writing support under the direction of authors, was provided by Sinead Holland, PhD, (Ashfield MedComms, an Inizio company) and funded by
Slide 27: Disclosures
Disclosures JSA: Consulting/advisory role (AbbVie, ADC Therapeutics, AstraZeneca, BeiGene, BMS, Cellectar, Caribou Biosciences, Celgene, Genentech, Inc., Gilead, Incyte, Interius, Janssen, Lilly, Novartis, F. Hoffmann-La Roche Ltd, Seagen, Takeda), and research funding (BMS, Cellectis, Merck, Mustan
Slide 28: Roche Bispecific Antibodies in NHL
Roche Bispecific Antibodies in NHL William Waas Lifecycle Leader NHL Bispecific Program, Global Product Strategy
Slide 29: Roche: Driving innovation in NHL treatment for over 25 years
Hematology Roche: Driving innovation in NHL treatment for over 25 years Flexible, tailored solutions to meet unique needs and provide the best outcomes chemotherapy Diffuse Large B cell Lymphoma Follicular Lymphoma (DLBCL) (FL) chemotherapy 2L 1L 3L+ 1997-today 1L 2L 3L+ CHOP benda chemo benda 1997
Slide 30: NHL development program progressing
Hematology NHL development program progressing Ph III trials initiated with Lunsumio or Columvi in earlier lines of FL and DLBCL treatment For outpatient setting, indolent Comprehensive clinical trial program across multiple NHL indications disease (FL) and elderly/unfit pts • No required hospitaliz
Slide 31: Ph III STARGLO: Columvi + GemOx reduces risk of death by 41% in 2L DLBCL
Hematology Ph III STARGLO: Columvi + GemOx reduces risk of death by 41% in 2L DLBCL1 Columvi is the first CD20xCD3 bispecific to demonstrate an OS benefit in DLBCL Median OS for Columvi + GemOx was nearly Columvi + GemOx significantly improved double that of R-GemOx* PFS and CR rates* R-GemOx Columv
Slide 32: Ph III SUNMO: Chemo-free combo of two unique MoAs in 2L DLBCL
Hematology Ph III SUNMO: Chemo-free combo of two unique MoAs in 2L DLBCL High activity and durable responses for patients unable to tolerate chemo Ph Ib/II (GO40516): Lunsumio + Polivy shows durable Ph III SUNMO: Lunsumio + Polivy in 2L+ R/R aggressive LBCL3 ORR and CR rates in treating R/R LBCL2 Ef
Slide 33: Polivy+R-CHP: New SoC with >23k patients treated to date in 1L DLBCL
Hematology Polivy+R-CHP: New SoC with >23k patients treated to date in 1L DLBCL Strong global launch in 1L DLBCL; Polivy on track for blockbuster status in 2024 Ph III (POLARIX): Polivy+R-CHP with a Polivy + R-CHP is the only regimen approved for 1L PFS HR of 0.76 at 36 months1 DLBCL in the last 20
Slide 34: Ph III SKYGLO: Columvi + Polivy-R-CHP in 1L DLBCL
Hematology Ph III SKYGLO: Columvi + Polivy-R-CHP in 1L DLBCL Early data support the potential for Columvi in combination with current SoC Ph Ib (NP40126): High response rates and promising PFS with Ph III SKYGLO: Columvi + Polivy-R-CHP in 1L DLBCL Columvi in combination with Pola-R-CHP and R-CHOP1 P
Slide 35: Hemlibra: Improving Patient Experience
Hemlibra: Improving Patient Experience Daud Chaudry Lifecycle Leader Hemophilia Bispecifics, Global Product Strategy
Slide 36: Continued global market share gains expected
Hematology Continued global market share gains expected Global standard of care with ~40% patient share in US & EU5; >25,000 patients treated globally Geographic expansion Future growth opportunities Key success factors ● Strong uptake in non-inhibitor indication (shares >70% in some markets) ● Furt
Slide 37: Transformative treatment option for broad Hem A population
Hematology Transformative treatment option for broad Hem A population Extensive clinical trial programs in Hem A, with BEYOND ABR read-out expected in 2025 Hemlibra clinical program overview HAVEN-1 HAVEN-2 HAVEN-3 HAVEN-4 HAVEN-5 HAVEN-6 HAVEN-7 STASEY NIS BEYOND ABR Study Inhibitor Pediatric Non-i
Slide 38: HAVEN 1-4: Efficacious bleed protection and proven safety profile
Hematology HAVEN 1-4: Efficacious bleed protection and proven safety profile Strong clinical profile established and confirmed in >10 years of studies & follow-up Efficacy - HAVEN 1-4 long-term analysis1 Safety - HAVEN 1-4 long-term analysis1,2 Proportion of patients with 0 or 1–3 treated Long-term
Slide 39: Real-world data: Validates strong clinical efficacy & safety profile
Hematology Real-world data: Validates strong clinical efficacy & safety profile Extensive real-world evidence base of >100 publications with data for >10,000 patients Efficacy - Real-world Safety - Real-world Annual joint bleeding rates1 EUHASS real-world study (n=1,007)4 -87% p=0.0435 Median/Mean A
Slide 40: Multiple dosing frequencies available to match patient preferences
Hematology Multiple dosing frequencies available to match patient preferences Same strong efficacy & safety profile across all approved dosing frequencies Flexible dosing options and sustained bleed protection Dosing frequency preference Patients preferring ease of subcutaneous administration over I
Slide 41: High patient satisfaction and convenient administration
Hematology High patient satisfaction and convenient administration New convenience options to be launched in 2024/2025 and autoinjector in development High patient satisfaction Further improving administration options Clinical and real-world insights (share of pts.) Preference over previous treatmen
Slide 42: Q&A and closing
Q&A and closing
Slide 43: Doing now what patients need next
Doing now what patients need next