Roche Holding Ltd · SIX:RO
Roche — ASCO 2026 Roche IR Event
59 slides from Roche's conference presentation, Jun 2, 2026
Slide 1: Roche logo
Slide 2: ASCO 2026 Roche IR Event
ASCO 2026 Roche IR Event 02 June 2026
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 Roche oncology strategy and portfolio highlights Wendy Cheung, SVP, Therapeutic Area Head Oncology & Hematology, Global Pharma Strategy Breast cancer franchise update Aakanksha Khandelwal, VP, Disease Area Head Breast & Gynecological Cancers Fr
Slide 6: Hematology pipeline update
Hematology pipeline update Ph III CELESTIMO in 2L FL to readout in H2 2026 and Ph III SKYGLO in 1L DLBCL to readout in 2027 Hematology performance Hematology pipeline molecule indication Ph I Ph II Ph III status Q1 2026 sales (YoY CER growth) Malignant heme Pola+R-CHP 1L DLBCL POLARIX Columvi + Poli
Slide 7: Roche oncology strategy and portfolio highlights
Roche oncology strategy and portfolio highlights Wendy Cheung SVP, Therapeutic Area Head Oncology & Hematology, Global Pharma Strategy
Slide 8: Oncology & hematology is Roche's largest Therapeutic Area by revenue
Oncology & hematology is Roche’s largest Therapeutic Area by revenue Focus on E2E disease areas to unlock the next wave of innovation Pipeline highlights Q1 2026 sales since 2024 (YoY CER growth) Breast cancer 6 positive Ph III readouts CHF Lung cancer 3 NME Ph III decisions CHF 5.9bn 14.7bn (+8%) 7
Slide 9: A diversified oncology pipeline by drug modalities and targets
A diversified oncology pipeline by drug modalities and targets Leveraging BD to catalyze portfolio rejuvenation and investigate new modalities Small Bispecifics/ Antibody-drug Cyclic Antibodies molecules trispecifics conjugates peptides ▪ giredestrant ▪ anti-CTLA-4 switch1 ▪ cevostamab ▪ cMET ADC2 ▪
Slide 10: Building a diverse pipeline of mutant selective and pan-RAS inhibitors
Building a diverse pipeline of mutant selective and pan-RAS inhibitors RAS market projected to represent one of the largest opportunities in oncology RAS mutation frequency Roche RAS-targeted pipeline molecule indication Ph I Ph II Ph III status 100 Other Solid Tumors 2L mNSCLC H2H vs Readout divara
Slide 11: Divarasib: Potentially best-in-class oral KRAS G12C inhibitor
Divarasib: Potentially best-in-class oral KRAS G12C inhibitor Ph III KRASCENDO 1 trial in 2L KRAS G12C mNSCLC (H2H vs sotorasib and adagrasib) readout exp 2H’26 Divarasib potency and selectivity1 Ph I results in 2L mNSCLC2 Divarasib cORR mPFS 400 mg (n=44) 59.1%* 15.3 mo IC50 (nM) / selectivity Diva
Slide 12: Strong divarasib activity in 1L NSCLC in combination with pembro
Strong divarasib activity in 1L NSCLC in combination with pembro Potential to be established as first ‘chemo-free’ regimen in 1L KRAS G12C NSCLC, regardless of PD-L1 status Ph II KRASCENDO 170 efficacy1 Ph II KRASCENDO 170 safety1 PD-L1 Positive Cohort, 400mg (N=59)* Overall safety summary: cohorts
Slide 13: Breast cancer franchise update
Breast cancer franchise update Aakanksha Khandelwal VP, Disease Area Head Breast & Gynecological Cancers Franchise, Global Pharma Strategy
Slide 14: Breast cancer is the largest oncology indication by revenue
Breast cancer is the largest oncology indication by revenue Strong legacy in HER2+ BC, expanding into ER+ BC; expected giredestrant approval by end of November 2026 Breast cancer market Q1 2026 performance Market share by oncology indication [% share, 2024]1 Q1 2026 sales (YoY CER growth) Breast Str
Slide 15: Portfolio of potentially BIC molecules to further improve SoC in BC
Portfolio of potentially BIC molecules to further improve SoC in BC Targeting key signaling nodes that drive etiology and progression of BC Differentiated molecules with a potential to redefine BC treatment paradigm as monotherapy and in combinations RG6596 (ZN-1041): Highly selective, brain-penetra
Slide 16: HER2+ evolving treatment paradigm
HER2+ evolving treatment paradigm Significant unmet medical need in metastatic HER2+ BC HER2+ BC treatment paradigm to evolve further Further opportunities and unmet Neoadjuvant Adjuvant cont. First line need in HER2+ BC PCR (55%) giredestrant 65% (heredERA) ▪ Induction/maintenance regimens which Su
Slide 17: RG6596 (ZN-1041): Highly selective, brain-penetrant HER2 TKI in Ph II/III
RG6596 (ZN-1041): Highly selective, brain-penetrant HER2 TKI in Ph II/III Potential for combinations to improve HER2+ BC outcomes and prevent brain metastases ZN-1041 properties1 Global Phase 1c study results3 Efflux transporter ZN-1041 800 mg + T-DXd ZN-1041 600 mg + T-DXd ZN-1041 + PH target tumor
Slide 18: ER+ BC represents a significant market opportunity
ER+ BC represents a significant market opportunity Adjuvant constitutes the largest population; projected to be the main growth driver of the ER+ market Breast cancer by subtype1 ER+ BC epidemiology by LoT ER+ BC market growth by LoT2 6% 273k 50 11% 4% Drug-treated, US + EU5 40 9% 70% 30 20 ER+/HER2
Slide 19: Giredestrant: Next gen. SERD with potential to become SoC backbone ET
Giredestrant: Next gen. SERD with potential to become SoC backbone ET Deep and sustained ER inhibition; superior potency over other SERDs, allowing lowest therapeutic dose in class Selective ER degrader (SERD)1 Preclinical potency3-5 Full ER antagonist2,6,7 Target coverage at 4,000 therapeutic dose
Slide 20: Giredestrant has shown positive results in both adjuvant and mBC
Giredestrant has shown positive results in both adjuvant and mBC First and only oral SERD to show positive Ph III results in adjuvant ER+ BC; lower discontinuation rates vs SoC ET Efficacy and safety in Phase III ▪ 30% reduction in recurrence or death vs SoC ET ▪ Clear positive OS trend (HR 0.79 at
Slide 21: Giredestrant may become SoC across a broad adjuvant risk spectrum
Giredestrant may become SoC across a broad adjuvant risk spectrum With the expected approval by end of November 2026, giredestrant will have the FIC advantage in adjuvant BC lidERA population vs current treatments in adjuvant ER+ BC US filing acceptance Low risk Intermediate Medium risk High risk (5
Slide 22: High unmet need for an effective and better tolerated adjuvant Tx
High unmet need for an effective and better tolerated adjuvant Tx Giredestrant is designed to overcome the limitations of the current treatment options Treatment of ER+ HER2- eBC Key opportunities for giredestrant 2025 US adjuvant therapy utilization2 ▪ Patients not on CDK4/6i (>90% intermediate ris
Slide 23: Expanding clinical program to establish giredestrant as the ET backbone
Expanding clinical program to establish giredestrant as the ET backbone giredestrant Low risk Intermediate Medium risk High risk 1 Neodjuvant ER+/HER2- BC (coopERA) (55-60%)1 risk (~10%)1 (15-20%)1 (~15%)1 giredestrant 1 2 Adjuvant ER+/HER2- BC Neoadj gire + (lidERA) CDK4/6i abemaciclib 100 pts (IA
Slide 24: Expanding clinical program to establish giredestrant as the ET backbone
Expanding clinical program to establish giredestrant as the ET backbone Two new Ph IIIb studies in upfront, all risk, AI-intolerant and switch settings giredestrant Low risk Intermediate Medium risk High risk 1 Neodjuvant ER+/HER2- BC (coopERA) (55-60%)1 risk (~10%)1 (15-20%)1 (~15%)1 giredestrant 1
Slide 25: RG6794 (GDC-4198): CDK4/2i to overcome CDK2-driven resistance
RG6794 (GDC-4198): CDK4/2i to overcome CDK2-driven resistance Encouraging preclinical activity in post-CDK4/6i setting CDK4/6i resistance mechanism1,2 Activity against CDK4 & CDK23 Preliminary activity in post-CDK4/6i setting4 IC50 (nM) CDK4 CDK2 GDC-4198 0.3 4.6 abemaciclib 0.8 270 palbociclib 2.3
Slide 26: Itovebi: Defining new SoC in PIK3CAm ER+ BC
Itovebi: Defining new SoC in PIK3CAm ER+ BC Approved in US, EU and China, additional launches ongoing PI3Kα inhibitor with dual MoA Ph III (INAVO120) OS results in 1L ER+/HER2- mBC2 Potency/selectivity (inavolisib vs alpelisib)1 Median, 96.8 months Fold change (inavolisib vs alpelisib) 100 87.0 Inav
Slide 27: Itovebi: Potential to expand broadly in PIK3CAm BC
Itovebi: Potential to expand broadly in PIK3CAm BC Giredestrant combinations to be explored Low risk Intermediate Medium risk High risk inavolisib untreated, PIK3CAm, 1 Ph II ongoing (55-60%)1 risk (~10%)1 (15-20%)1 (~15%)1 (neoTOV) stage II—III, ER+/HER2- BC 1 inavolisib 1L PIK3CAm ET + CDK4/6i 2 O
Slide 28: Giredestrant Ph III study results in breast cancer: evERA, persevERA, lidERA
Giredestrant Ph III study results in breast cancer: evERA, persevERA, lidERA Aditya Bardia MD, MPH, FASCO Professor of Medicine, Geffen School of Medicine, University of California Los Angeles
Slide 29: Disclosure information
Disclosure information Aditya L. Bardia. I have the following relevant financial relationships to disclose: • Consultant/advisory board: Alyssum, BMS, Daiichi Pharma/AstraZeneca, Eli Lilly, Genentech, Inc., Gilead, Menarini, Merck, Novartis, Pfizer, Sanofi, and Vyome. • Contracted research/grant (to
Slide 30: Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment: lidERA
Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment for patients with estrogen receptor-positive, HER2-negative early breast cancer: Results from the global Phase III lidERA Breast Cancer trial Presenting author: Aditya L. Bardia, MD University of California, Los Angeles, Los An
Slide 31: Background – giredestrant
Background – giredestrant • In cellular viability assays, giredestrant ESR1 WT, coopERA ER-active Breast has been shown to be more potent than cell lines Cancer other SERDs.1–5 in vitro5 primary analysis6 • In eBC, giredestrant demonstrated superior antiproliferative activity in the neoadjuvant sett
Slide 32: lidERA Breast Cancer study design
lidERA Breast Cancer study design A global, randomized, open-label, multicenter Phase III trial At least 5-year treatment duration 5-year follow-up Key eligibility criteria • Participants with ER+, HER2-negative early breast cancer N = 4170 • Stage I–III disease (anatomical) Giredestrant (30 mg PO Q
Slide 33: Primary endpoint: IDFS
lidERA Breast Cancer Primary endpoint: IDFS 100 Giredestrant SOC ET + Giredestrant + everolimus SOC ET everolimus 80 100 97.7% n(n= =2084 102) n(n==2086 105) 94.6% Events, n (%) 140 (6.7) 196 (9.4) 96.9% 92.4% 60 Stratified HR 0.70 IDFS (%) 90 92.3% (95% CI) (0.57, 0.87); p = 0.0014* 89.6% 40 Explor
Slide 34: IDFS in key subgroups
lidERA Breast Cancer IDFS in key subgroups Patients, n Total, n Giredestrant SOC ET HR (95% CI) All patients 4170 2084 2086 0.70 (0.57, 0.87) Age group, years ≤ 45 906 472 434 0.81 (0.50, 1.33) > 45 to ≤ 55 1355 660 695 0.54 (0.36, 0.80) > 55 to ≤ 65 1118 567 551 0.77 (0.53, 1.13) > 65 791 385 406 0
Slide 35: Interim overall survival
lidERA Breast Cancer Interim overall survival 100 80 99.5% 100 98.2% 99.4% 97.0% 97.5% Giredestrant SOC ET + 95.9% +Giredestrant everolimus SOC ET everolimus 60 n= (n = 2084 102) n= (n = 2086 105) OS (%) Events, n (%) 57 (2.7) 71 (3.4) 90 40 Stratified HR 0.79 (95% CI) (0.56, 1.12); p = 0.1863* 20 8
Slide 36: Safety overview (safety-evaluable population)
lidERA Breast Cancer Safety overview (safety-evaluable population) Giredestrant SOC ET n = 2060 n = 2074 Median treatment duration, months (range) 31.64 (0.03–46.36) 30.88 (0.03–46.26) Mean dose intensity, % (SD) 98.77 (3.07) 98.68 (3.73) Patients with ≥ 1 AE, n (%) AEs (all grades) 1955 (94.9) 1957
Slide 37: AE overview (safety-evaluable population)
lidERA Breast Cancer AE overview (safety-evaluable population) Common TEAEs (≥ 7.5% of patients in either arm at any grade) Selected AEs Giredestrant SOC ET Giredestrant n = 2060 SOC ET n = 2074 n = 2060 n = 2074 Arthralgia 1.5 / 46.5 45.3 / 1.8 Patients, n (%) with treatment discontinuations due to
Slide 38: Conclusions
lidERA Breast Cancer Conclusions • Since approval of AIs in the 2000s, lidERA Breast Cancer is the first trial to demonstrate benefit with a novel ET in early breast cancer (eBC). • With a median follow-up of 32.3 months, the lidERA trial demonstrated a statistically significant and clinically meani
Slide 39: Giredestrant + palbociclib vs letrozole + palbociclib as 1L therapy: persevERA
Giredestrant (GIRE) + palbociclib (PALBO) vs letrozole (LET) + PALBO as first-line (1L) therapy in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer (ER+, HER2– LA/mBC): Primary analysis of the Phase III persevERA BC trial. Nicholas C. Turner,
Slide 40: persevERA BC study design
persevERA BC study design A Phase III, randomized, double-blind, placebo-controlled, multicenter trial in 1L LA/mBC Key eligibility criteria: • 1L ER+, HER2– LA/mBC* Giredestrant 30 mg PO QD • Locally confirmed histologic/cytologic + placebo PO QD diagnosis + palbociclib 125 mg PO QD Day 1–21 N = 99
Slide 41: Statistical design
Statistical design Primary endpoint: INV-PFS • After the interim analysis, the p-value boundary for primary analysis is 0.0456 • Two-sided stratified log-rank test, with the HR estimated using a stratified Cox proportional hazards model • Primary analysis was planned to occur after approximately 620
Slide 42: Patient demographics and baseline characteristics
Patient demographics and baseline characteristics Giredestrant Letrozole Giredestrant Letrozole + palbociclib + palbociclib + palbociclib + palbociclib n = 495 n = 497 n = 495 n = 497 Median age, years (range) 63.0 (26–87) 63.0 (30–89) PgR status, n (%) Female sex, n (%) 491 (99.2) 493 (99.2) Positi
Slide 43: Primary endpoint: INV-PFS
Primary endpoint: INV-PFS 100 90 80 77.8% Giredestrant+ Giredestrant Letrozole SOC ET + 77.3% +everolimus palbociclib +everolimus palbociclib 70 n == 495 (n 102) n == 497 (n 105) 59.7% 60 57.3% Events, n (%) 300 (60.6) 323 (65.0) PFS (%) 45.8% 50 40 41.9% Median, months 33.1 28.2 30 (95% CI) (30.2,
Slide 44: INV-PFS in key subgroups
INV-PFS in key subgroups Giredestrant Letrozole + palbociclib + palbociclib n = 495 n = 497 Giredestrant Letrozole Total Median Median 95% Wald + palbociclib + palbociclib Baseline risk factors n n (months) n (months) HR CI better better All patients 992 495 33.1 497 28.2 0.89 (0.76, 1.04) Site of d
Slide 45: Secondary endpoint: OS
Secondary endpoint: OS 100 90 84.9% Giredestrant+ Giredestrant Letrozole SOC ET + +everolimus palbociclib +everolimus palbociclib 80 84.2% 74.1% n == 495 (n 102) n == 497 (n 105) 70 74.1% 60 Events, n (%) 172 (34.7) 166 (33.4) OS (%) 50 40 Median, months NE NE 30 (95% CI) (NE, NE) (61.3, NE) 20 Stra
Slide 46: Other key secondary endpoints
Other key secondary endpoints Giredestrant Letrozole 100 DoR Giredestrant + palbociclib Letrozole + palbociclib n = 280 n = 276 + palbociclib + palbociclib 90 Events, n (%) 143 (51.1) 158 (57.2) 80 n = 465 n = 469 Median, months 38.5 30.4 70 (95% CI) (30.4, 48.7) (25.3, 36.1) ORR, n (%) 280 (60.2) 2
Slide 47: Safety overview
Safety overview Giredestrant + palbociclib Letrozole + palbociclib n = 494 n = 495 Median treatment duration, months (range) Giredestrant: 29.8 (0–63.4)* Letrozole: 25.2 (0.2–62.6) Palbociclib: 28.3 (0–63.4) Palbociclib: 24.2 (0.2–62.6) Mean dose intensity, % (SD) Giredestrant: 98.2 (4.1) Letrozole:
Slide 48: AE overview
AE overview Common TEAEs (≥ 15% of patients in either arm) Selected AEs Neutropenia* 74.9% 14.2% 12.3% 73.3% Giredestrant Letrozole Anemia 6.3% 38.1% 34.7% 2.8% Patients with ≥ 1 AE, n (%) + palbociclib + palbociclib White blood cell count decreased n = 494 n = 495 Arthralgia Musculoskeletal pain Na
Slide 49: Summary
Summary • Giredestrant + palbociclib demonstrated a numerical improvement in INV-PFS compared with letrozole + palbociclib, although the study did not reach the pre-specified threshold for statistical significance: – HR: 0.89 (95% CI 0.76, 1.05); p = 0.1553 – Median INV-PFS: 33.1 vs 28.2 months • OR
Slide 50: Giredestrant + everolimus in ER+, HER2– advanced breast cancer: evERA BC
Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the Phase III evERA BC trial Erica L.
Slide 51: Study design
evERA Breast Study design Cancer A global, randomised, open-label, Phase III trial Enrolment period: August 2022 to October 2024 Key eligibility criteria* N = 373* • ER+, HER2– aBC (1–3L of therapy) Giredestrant (30 mg) + everolimus (10 mg)† Until PD • ≤ 2 prior lines of ET in the aBC setting R or •
Slide 52: Co-primary endpoint – INV-PFS in the ESR1m population
evERA Breast Cancer Co-primary endpoint – INV-PFS in the ESR1m population Giredestrant + SOC ET + Giredestrant + SOC ET + everolimus everolimus everolimus everolimus 100 n (n = =102 102) n(n==105 105) Events, n (%) 63 (61.8) 89 (84.8) 80 Median, mo (95% CI) 9.99 (8.08, 12.94) 5.45 (3.75, 5.62) 66.1
Slide 53: Co-primary endpoint – INV-PFS in the ITT population
evERA Breast Cancer Co-primary endpoint – INV-PFS in the ITT population Giredestrant + SOC ET + Giredestrant + SOC ET + everolimus everolimus everolimus everolimus 100 n (n = =183 102) n(n==190 105) Events, n (%) 126 (68.9) 163 (85.8) 80 Median, mo (95% CI) 8.77 (6.60, 9.59) 5.49 (4.01, 5.59) INV-PF
Slide 54: PFS2 in the overall study, ESR1m, and ESR1m not detected populations
PFS2 in the overall study, ESR1m, and ESR1m not detected populations Overall study ESR1m ESR1m not detected Giredestrant Giredestrant ++ SOC SOC ET ET + + everolimus Giredestrant Giredestrant ++ SOC SOC ET ET + + everolimus Giredestrant Giredestrant ++ SOC SOC ET + ET + everolimus everolimus everoli
Slide 55: Chemotherapy-free survival in the overall study, ESR1m, and ESR1m not detected populations
Chemotherapy-free survival in the overall study, ESR1m, and ESR1m not detected populations Overall study ESR1m ESR1m not detected Giredestrant Giredestrant ++ SOC SOC ET ET + + everolimus Giredestrant Giredestrant ++ SOC SOC ET ET + + everolimus Giredestrant Giredestrant ++ SOC SOC ET + ET + everoli
Slide 56: Favorable OS consistent with prolonged PFS2 and chemotherapy-free survival
At interim OS analysis,1 favorable OS was consistent with prolonged PFS2 and chemotherapy-free survival Overall study ESR1m ESR1m not detected Giredestrant Giredestrant ++ SOC SOC ET ET + + everolimus Giredestrant Giredestrant ++ SOC SOC ET ET + + everolimus Giredestrant Giredestrant ++ SOC SOC ET +
Slide 57: Safety overview
evERA Breast Cancer Safety overview Giredestrant + everolimus SOC ET + everolimus n = 182 n = 186 Giredestrant: 7.11 (0.46–28.78) SOC ET: 4.62 (0.03–27.63) Median treatment duration, mo (range) Everolimus: 6.03 (0.46–26.94) Everolimus: 4.14 (0.03–27.63) Giredestrant: 95.98 (9.50) SOC ET: 96.65 (8.14
Slide 58: Conclusions
evERA Breast Cancer Conclusions • The next-generation oral SERD giredestrant, in combination with everolimus, showed statistically significant and clinically meaningful improvements in INV-PFS vs SOC ET + everolimus in ER+, HER2– aBC post-CDK4/6i – ESR1m: 62% reduction in the risk of progression or
Slide 59: Doing now what patients need next
Doing now what patients need next