Roche Holding Ltd · SIX:RO
Roche — Investor Day (June 2021)
71 slides from Roche's investor day presentation, Jun 8, 2021
Slide 1: Roche Analyst Event
Roche Analyst Event Tuesday, 08 June 2021
Slide 2: 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 3: Welcome / Agenda
Welcome Karl Mahler, Head of Investor Relations and Group Business Planning Early pipeline programs in focus William Pao, M.D., Ph.D., Head of Roche Pharma Research and Early Development Ira Mellman, Ph.D., Vice President, Cancer Immunology, Genentech Research & Early Development Late-stage pipeline
Slide 4: Karl Mahler
Karl Mahler | Head of Investor Relations and Group Business Planning
Slide 5: Reflecting the quality of research and development at Roche
Reflecting the quality of research and development at Roche 37 Breakthrough Therapy Designations (BTD) since 2013 4 Year Molecule Indication Approvals under Real-Time Oncology tiragolumab +Tcq 1L PD-L1+ NSCLC review (RTOR) since start of the first 2020 mosunetuzumab 3L+ FL pilot program in 2018 Tece
Slide 6: Our technology platforms in oncology
Our technology platforms in oncology Roche pipeline includes differentiated therapeutic platforms Small Bi-specific Fusion mAb Antibody Personalized Personalized molecules mAb protein drug neoantigen T-cells conjugate vaccine mRNA Activated T cell with Vaccine design neoantigen DNA specificity 2:1 f
Slide 7: Early pipeline programs in focus: William Pao
Early pipeline programs in focus William Pao, M.D., Ph.D. | Head Roche Pharma Research & Early Development (pRED)
Slide 8: Roche pRED's contributions to launching new medicines
Roche pRED’s contributions to launching new medicines Science and innovation have been keys to success Newly launched Roche medicines since 2011 Molecules under full development • glofitamab - NHL • cibisatamab – MSS CRC • gantenerumab – AD • tominersen - HD • crovalimab* – PNH • SRP9001 – DMD • AT-
Slide 9: pRED oncology focus areas
pRED oncology focus areas Covering a range of modalities in line with state of the art cancer biology ‘Game Changing’ Innovation • New targets, technologies, collaborations and partnerships Cancer Immunotherapy large molecules Molecular Targeted • Direct T-cell engagers Therapy (MTT) – small molecul
Slide 10: Harnessing external innovation: 2018-2021
Harnessing external innovation: 2018-2021 In-licensing projects of high scientific quality and strategic fit Multiple strategic partnerships with biotech and academia Orano Med Pre-targeted radiotherapy using alpha-emitters (CIT) Blueprint 2 programs in preclinical phase Tusk Acquisition (MTT) CD25
Slide 11: pRED Oncology development pipeline
pRED Oncology development pipeline Ph0 Phase1/2 MTT Cellular Signaling NME HPV-PBMC vaccine Immune Cell Generators Targ. TLR7 agonist NME selicrelumab NME cibisatamab T-Cell Engagers HLA-A2-WT1 x CD3 NME TYRP1 x CD3 CIT NME PD1-LAG3 Checkpoint Inhibition PD1-TIM3 Immune Cell Other NME PD1 IL2v Modul
Slide 12: T-cell Bispecifics in early clinical development
T-cell Bispecifics in early clinical development: Redirect T-cell attack Utilizing novel 2:1 format for maximal efficacy 2:1 format TCB, targeting tumor antigen and CD31 Late clinical development - Cibisatamab – carcinoembryonic antigen; colorectal cancer - Glofitamab – CD20; Non-Hodgkin lymphoma An
Slide 13: Glofitamab: Flexibility to combine with anti-CD20 mAbs
Glofitamab: Flexibility to combine with anti-CD20 mAbs Glofitamab 2:1 format: Option to Glofitamab + Gazyva: combine with Rituxan (R) and Gazyva (G) strong efficacy demonstrated in preclinical and clinical studies 1:1 bispecific 5000 OCI-Ly18/hu-mice DLBCL model Anti-tumor activity observed in T u m
Slide 14: Rapid non-invasive whole-body monitoring of r/r NHL patients
Assessing the potential of rapid non-invasive whole-body monitoring of patients with r/r NHL treated with glofitamab* Preclinical studies with novel CD8 T-cell PET tracer using CEA TCB as proof of concept • CEA-4-1BBL/CEA-TCB combination induced the strongest tumor regression PET/CT imaging of CD8 T
Slide 15: Glofitamab in combination with CD19-4-1BBL
Glofitamab in combination with CD19-4-1BBL (RG6076) Potential for off-the-shelf alternative to 2nd generation CD19-CAR-T-cell Improved tumor growth Significantly enhanced CD19-4-1BBL + CD20xCD3 inhibition T-cell infiltration WSU-DLCL2/hu-mice DLBCL model Fc part silenced • Signal 1: NK or T-cell act
Slide 16: HLA-A2 WT1 x CD3 (RG6007)
HLA-A2 WT1 x CD3 (RG6007) targeting intracellular oncoprotein WT1 TCR receptor-like T-cell bispecific for heme and solid tumors Broadens potential tumor targets beyond cell RG6007 induced dose dependent surface proteins reduction of tumor growth Tumor growth Tumor volume (mm3)+/- SEM Days SKM-1 Mode
Slide 17: PD1 mAbs in early clinical development
PD1 mAbs in early clinical development Enhancing activity of standard of care checkpoint inhibitors PD1-LAG3/RG6139 PD1-TIM3/RG7769 PD1-IL2v/RG6279 Bivalent high avidity LAG-3 PD-1 TIM-3 PD-1 binding to PD-1 PGLALA-Fc IL-2 variant fused to Fc PGLALA-Fc PGLALA-Fc region • Ph 1 dose expansion cohorts
Slide 18: PD1 mAbs in early clinical development
PD1 mAbs in early clinical development Enhancing activity of standard of care checkpoint inhibitors PD1-LAG3/RG6139 PD1-TIM3/RG7769 PD1-IL2v/RG6279 Bivalent high avidity LAG-3 PD-1 TIM-3 PD-1 binding to PD-1 PGLALA-Fc IL-2 variant fused to Fc PGLALA-Fc PGLALA-Fc region • Ph 1 dose expansion cohorts
Slide 19: PD1-IL2v (RG6279): Delivering IL2 variant to PD-1+ T-cells
PD1-IL2v (RG6279): Delivering IL2 variant to PD-1+ T-cells IL2v preferentially activates effector T cells IL2v delivery to PD-1+ T cells Superior approach to exploit tumor-specific T-cells vs. CPI alone Fresh-Better Effectors PD-1-IL2v/RG6279 Reduce GzB IL-2R PD-1 PD-1 Ki67 IL-2R TCF- Resource 1 IL-
Slide 20: Encouraging preclinical activity of cis-targeted PD1-IL2v
Encouraging preclinical activity of cis-targeted PD1-IL2v (RG6279) PD1-IL2v: Superior efficacy vs. aPD-1 and PD1-IL2v: Enhanced efficacy in combination with aPD-L1 aPD-1 + FAP-IL2v Ultrasound images of complete response Orthotopic PancO2-H7 model1 in RT5 model; collaboration with D. Hanahan, SLCC2 •
Slide 21: Anti-CD25 (RG6292)
Anti-CD25 (RG6292) Selective regulatory T-cell depletion without affecting IL-2 signaling Immune suppressive Immune permissive FC receptor NK cell Anti-CD25, 1 Non-IL-2 blocking, avidity dependent anti-CD25 coats regulatory T-cells RG6292 IL-2 consumed by regulatory T-cells IL-2 2 Afucoslylation of
Slide 22: Anti-CD25 (RG6292) clinical data
Anti-CD25 (RG6292) Selective regulatory T-cell depletion without affecting IL-2 signaling Preferential binding of RG6292 RG6292 induces dose dependent RG6292 induced an to iTregs in vitro blood Treg depletion in patients inflamed tumor type in patients aCD25 Dose: 0.3 mg isotype control 1 mg % chang
Slide 23: Increasing the therapeutic index of T-cell Bispecifics
Increasing the therapeutic index of T-cell Bispecifics via novel protein engineering Enhancing specificity and safety of TCBs by masking the anti-CD3 Fab fragment Blocked Activated • Protease-activation using anti-idiotypic masks enables tumor specificity of a T-cell bispecific allowing for optimize
Slide 24: Ira Mellman
Early pipeline programs in focus Ira Mellman, Ph.D. | Vice President, Cancer Immunology, Genentech Research & Early Development (gRED)
Slide 25: Robust gRED oncology portfolio
Robust gRED oncology portfolio Phase 1 Phase 2 Phase 3 Oncology *Anti-BCMA/CD16a *Autogene cevumeran *ipatasertib Anti-HER2/CD3 TDB mosunetuzumab *belvarafenib inavolisib (mPI3Ka inh) Targeted Therapy cevostamab (FcRH5xCD3) giredestrant (SERD) *IL15/IL15-Ra-Fc tiragolumab *DNA vaccine Cancer Immunot
Slide 26: Ras-MAPK pathway in cancer
Ras-MAPK pathway in cancer Due to pathway cross-talk and feedback mechanisms, combination strategies are required for optimal clinical effectiveness and to tackle resistance gRED portfolio Late stage portfolio / marketed
Slide 27: GDC-6036 (KRAS G12C inhibitor) in solid tumors
GDC-6036 (KRAS G12C inhibitor) in solid tumors G12C driver mutations found in 12% of all NSCLC patients KRAS G12C inhibitor High unmet need remains in KRAS G12c mutant tumors In vitro cell line potency The RAS pathway Genentech unpublished results Simanshu, Cell, 2017 • Highly potent irreversible co
Slide 28: Belvarafenib is a potent and selective RAF dimer inhibitor
Belvarafenib is a potent and selective RAF dimer inhibitor Selective inhibition of mutant RAF dimers Promising efficacy in CPI-experienced NRAS melanoma Belvarafenib + Cobimetinib: Ph 1b expansion in NRAS melanoma* N=9 belvarafenib • Inhibition of RAF dimers, including downstream of RAS • Responses
Slide 29: Strategies to promote an antitumor immune response by phenotype
Strategies to promote an antitumor immune response by phenotype Target “rate limiting steps” associated with primary and secondary resistance IMMUNE EXCLUDED IMMUNE DESERT Recruit T cells to tumour Generate/release/deliver antigens Address stromal barrier Enhance antigen presentation and Redirect an
Slide 30: Multiple modalities to leverage T cell immunotherapy
Multiple modalities and approaches to leverage T cell immunotherapy Monoclonal Bispecific Neoantigen NeoT antibodies antibodies Cytokines vaccines cell therapy 30
Slide 31: Why choose TIGIT?
There are many T cell checkpoints to combine with PD-1/L1 blockade, why choose TIGIT? TIGIT is an inhibitory receptor discovered at Genentech • First checkpoint inhibitor to yield positive randomized data in NSCLC in combination with PD-1/L1 • Only negative regulator besides PD-1 expressed by Tscm c
Slide 32: Convergence of the TIGIT and PD-1 pathways
The convergence of the TIGIT and PD-1 pathways: CD226 and CD28 are both “clients” of PD-1 Dendritic cell PVR PD-L1 B7.1/ B7.2 • TIGIT competes with CD226 for ligand binding TIGIT PD-1 • PD-1 mediates dephosphorylation of both CD28 and CD226 CD226 CD28 • Optimal activation of costimulation requires c
Slide 33: TIGIT activity and myeloid cells, Tregs, NK cells
TIGIT activity may also reflect modulation of myeloid cells, CD226 suppression of Tregs, NK cell activation Modulation of myeloid (dendritic) cells CD226 signaling may dampen TIGIT is also expressed by creates proinflammatory tumor Treg suppression, promote NK cells, unlike PD-1 microenvironment1 ef
Slide 34: gRED bispecific antibody portfolio
gRED bispecific antibody portfolio Mosunetuzumab Cevostamab RG6296 RG6194 CD20 x CD3 FcRH5 x CD3 BCMA x CD16A HER2 x CD3 34
Slide 35: Cevostamab (FcRH5 x CD3)
Cevostamab (FcRH5 x CD3) Promising activity in heavily pretreated R/R MM patients FcRH5 Cevostamab Ph 1 dose escalation in R/R MM 100 Response rate in ≥3.6/20mg cohorts T cell 80 Activation ORR: 53% ≥CR: 18% ORR: 61% ≥VGPR: 32% Rate (%) 60 sCR: 6% CD3 Apoptosis ORR: 44% CR: 11% sCR: 12% FcRH5 Synaps
Slide 36: Autogene cevumeran, individualized neoantigen mRNA vaccine
Autogene cevumeran, individualized neoantigen mRNA vaccine Ph II studies underway in 1L melanoma • Fully individualized vaccine: mRNA vectors provide patient specific therapy In collaboration with • Novel algorithms predict neoantigens recognized by T cells • On demand-production (highly iterated an
Slide 37: DNA vaccine with distinct mechanism
DNA vaccine with distinct mechanism to activate immune response In collaboration with Ph1 showed neoantigen-specific T cell responses in patients (SITC 2019) 37
Slide 38: NeoT: Personalized T cell therapy
NeoT: Personalized T cell therapy directed at neoantigens In collaboration with TCR: T cell receptor, HLA: human leukocyte antigen; PBL: peripheral blood leukocytes 38
Slide 39: Levi Garraway: Late-stage programs in focus
Late-stage programs in focus Levi Garraway, M.D., Ph.D | Chief Medical Officer and Head of Global Product Development
Slide 40: Significant near-term oncology news flow
Significant near-term oncology news flow Key upcoming oncology news flow New Molecular Entity (NME) Additional Indication (AI) Oncology / Hematology Product Indication Data/filing NSCLC adj 2021 SCCHN adj 2022 RCC adj 2022 Tecentriq 1L mUC 2022 NSCLC neoadj 2022 HCC adj 2022 Alecensa ALK+ NSCLC adj
Slide 41: Innovation for patients across solid tumors and hematology
Innovation for patients across solid tumors and hematology Moving earlier in disease • Curative potential for the largest number of patients • Increasing screening, early detection technologies Exploring rational combinations, new indications • Combinations: tiragolumab+Tecentriq, Polivy+mosun/glofi
Slide 42: Earlier disease presents the opportunity for a cure
Earlier disease presents the opportunity for a cure Need for high efficacy treatments that are well tolerated Outcomes by cancer type and stage at diagnosis1 Chance for a cure: development earlier in the course of 100% disease is critically important to improving the cure rate Cost to society: treat
Slide 43: Investing earlier in disease
Investing earlier in disease Lung / Rare GI / GU Molecule Indication Ph 1 Ph 2 Ph 3 Molecule Indication Ph 1 Ph 2 Ph 3 Adjuvant NSCLC IMpower010 Adjuvant RCC IMmotion010 Tecentriq Neoadjuvant NSCLC IMpower030 Adjuvant HCC IMbrave050 Adjuvant SCCHN IMvoke010 HR NMIBC ALBAN Tecentriq Stage III unres.
Slide 44: High unmet need in adjuvant NSCLC
High unmet need in adjuvant NSCLC Tecentriq filed with FDA under RTOR High unmet need in early NSCLC 5-year OS by disease stage1 100% Adjuvant NSCLC treatment is still evolving 90% 80% 70% 60% Screening: Early detection technologies 50% expected to increase diagnosis at early stage 40% 30% 20% 10% T
Slide 45: Tiragolumab development program: scientific and clinical rationale
Tiragolumab (anti-TIGIT) development program: scientific and clinical rationale Scientific / clinical evidence Example: Ph 3 investment CITYSCAPE Ph 2 trial SKYSCRAPER-01 (PD-L1+ NSCLC) PFS benefit observed on top of • Confirm CITYSCAPE results Tecentriq in randomized trial Ph 1b expansion cohorts S
Slide 46: Tiragolumab development program
Tiragolumab development program First Ph 3 data reading out in 2022: SKYSCRAPER-02 (SCLC) Nine Ph II/III trials of tiragolumab + Tecentriq initiated Development Strategy Lung Cancer Additional solid tumors Build on Tecentriq Indication Ph 1 Ph 2 Ph 3 Indication Ph 1 Ph 2 Ph 3 1L NSCLC: PD-L1 high SK
Slide 47: Giredestrant (SERD)
Giredestrant (SERD) High unmet need remains across HR+/HER2- eBC and mBC ET is a mainstay of HR+ BC treatment Potential for best-in-class profile in HR+ BC • Novel MOA: immobilizes ER in the nucleus prior to degradation 20-50% • High potency: 7-15x more potent than other SERDs in development of HR+
Slide 48: Giredestrant (SERD): Promising activity
Giredestrant (SERD) Promising activity across HR+/HER2- mBC and eBC HR+/HER2- mBC Stage I-III neoadjuvant treatment Ph 1b: giredestrant monotherapy Window of Opportunity Study Ki67 Clinical activity 30mg (n=41) Response at Surgery ORR* 20% CBR 55% resistant Prior fulvestrant 3/8 (38%) Prior CDK4/6i
Slide 49: Polivy readout in 1L DLBCL expected in 2021
Polivy readout in 1L DLBCL expected in 2021 Opportunity to establish Polivy as standard of care in curative setting 1L DLBCL treatment can be curative… DLBCL Patient …however high unmet need in remains in 1L DLBCL 1L R-CHOP • ~40% of patients not cured with R-CHOP in 1L • Patients with R/R DLBCL hav
Slide 50: Roche CD20 x CD3 bispecific portfolio
Roche CD20 x CD3 bispecific portfolio can be tailored to address diverse patient and customer needs • FL/DLBCL/other histologies Patients • 1L or R/R disease Mosunetuzumab + • Patient characteristics, including risk/prognostic factors Attractive profile for the outpatient setting and • Single agent
Slide 51: Mosunetuzumab and glofitamab development plans
Mosunetuzumab and glofitamab development plans Moving into earlier lines of therapy in combination with SOC Late line monotherapy R/R NHL combinations 1L DLBCL Pivotal cohorts reading out in 2021 Randomized Ph 3 trials initiated Developing in curative setting • Mosun filing in 2021 in 3L+ FL • Mosun
Slide 52: Glofitamab
Glofitamab Potential for best-in-class efficacy with step-up dosing Activity in R/R aNHL • High and durable response rates in R/R aggressive NHL patients who have failed multiple lines of therapy • CR rate of 71.4% at RP2D (2.5/10/30mg) • CRS was mostly low grade, and confined to cycles 1-2 All aNHL
Slide 53: Mosunetuzumab + Polivy
Mosunetuzumab + Polivy Novel combination with promising safety and efficacy Phase Ib/II dose escalation • Promising efficacy in patients with R/R NHL, including in post-CAR-T patients • M-Pola has an acceptable safety profile with low Gr 1 (2/22, 9%) and no Gr ≥2 CRS events observed • Ph 2 expansion
Slide 54: ASCO 2021 Highlight: Heather Wakelee
ASCO 2021 Highlight Tecentriq in adjuvant NSCLC: Phase 3 IMpower010 primary results Heather Wakelee, M.D | Prof. of Medicine, Stanford University Medical Center / Deputy Director Stanford Cancer Institute
Slide 55: IMpower010: Primary Results of a Phase 3 Global Study
IMpower010: Primary Results of a Phase 3 Global Study of Atezolizumab vs Best Supportive Care After Adjuvant Chemotherapy in Resected Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC) Heather A. Wakelee,1 Nasser Altorki,2 Caicun Zhou,3 Tibor Csőszi,4 Ihor O. Vynnychenko,5 Oleksandr Goloborodko,6 Alex
Slide 56: IMpower010: introduction
IMpower010: introduction • Adjuvant platinum-based chemotherapy changed the standard of care for completely resected early-stage NSCLC (stage IB-IIIA) over 15 years ago1-4 – DFS HR, 0.84 (95% CI: 0.78, 0.91) – OS HR, 0.89 (95% CI: 0.82, 0.96) – Leads to 4%-5% OS improvement at 5 years vs observation
Slide 57: IMpower010: study design
IMpower010: study design No crossover Atezolizumab Completely resected Cisplatin + 1200 mg q21d stage IB-IIIA NSCLC pemetrexed, 16 cycles per UICC/AJCC v7 gemcitabine, Survival docetaxel or R N=1005 follow-up • Stage IB tumors ≥4 cm vinorelbine 1:1 • ECOG 0-1 • Lobectomy/pneumonectomy 1-4 cycles BSC
Slide 58: IMpower010: statistical analysis plan
IMpower010: statistical analysis plan DFS in PD-L1 TC ≥1% stage II−IIIA population 2-sided α=0.05 • The primary DFS endpoint was If positive: tested hierarchically in 3 primary analysis populations DFS in all-randomized stage II−IIIA population 2-sided α=0.05 If positive: DFS in ITT population (stag
Slide 59: IMpower010: baseline characteristics
IMpower010: baseline characteristics PD-L1 TC ≥1% (SP263) (stage II-IIIA) All randomized (stage II-IIIA) ITT (stage IB-IIIA) All patients Characteristic Atezolizumab BSC Atezolizumab BSC Atezolizumab BSC (N=1005) (n=248) (n=228) (n=442) (n=440) (n=507) (n=498) Median (range) age, y 62 (26-84) 61 (34
Slide 60: IMpower010: DFS in the PD-L1 TC ≥1% population
IMpower010: DFS in the PD-L1 TC ≥1%a stage II-IIIA population (primary endpoint) Atezolizumab BSC (n=248) (n=228) Median DFS (95% CI), mo NE (36.1, NE) 35.3 (29.0, NE) Stratified HR (95% CI) 0.66 (0.50, 0.88) P valueb 0.004c Median follow-up: 32.8 mo (range, 0.1-57.5) Clinical cutoff: January 21, 20
Slide 61: DFS in key subgroups of PD-L1 TC ≥1% population
IMpower010: DFS in key subgroups of the PD-L1 TC ≥1%a stage II-IIIA population 61 Dr. Heather A. Wakelee IMpower010 Interim Analysis https://bit.ly/33t6JJP
Slide 62: IMpower010: DFS in the all-randomized stage II-IIIA population
IMpower010: DFS in the all-randomized stage II-IIIA population (primary endpoint) Atezolizumab BSC (n=442) (n=440) Median DFS (95% CI), mo 42.3 (36.0, NE) 35.3 (30.4, 46.4) Stratified HR (95% CI) 0.79 (0.64, 0.96) P valuea 0.02b Median follow-up: 32.2 mo (range, 0- 57.5) Clinical cutoff: January 21,
Slide 63: DFS in key subgroups of all-randomized population
IMpower010: DFS in key subgroups of the all-randomized stage II-IIIA population HR HR Atezolizumab better BSC better Atezolizumab better BSC better Clinical cutoff: January 21, 2021. a Stratified for all patients; unstratified for all other subgroups. 63 Dr. Heather A. Wakelee IMpower010 Interim Ana
Slide 64: IMpower010: statistical analysis plan
IMpower010: statistical analysis plan DFS in PD-L1 TC ≥1% stage II−IIIA population 2-sided α=0.05 • The significance boundary was not crossed at this DFS interim analysis If positive: in the ITT population (stage IB-IIIA) and testing will continue to the final DFS in all-randomized stage II−IIIA pop
Slide 65: IMpower010: DFS in the ITT population
IMpower010: DFS in the ITT population (stage IB-IIIA; primary endpoint) Atezolizumab BSC (n=507) (n=498) Median DFS (95% CI), mo NE (36.1, NE) 37.2 (31.6, NE) Stratified HR (95% CI) 0.81 (0.67, 0.99) P valuea 0.04b Median follow-up: 32.2 mo (range, 0-58.8) • DFS in the ITT population did not cross t
Slide 66: IMpower010: early OS data at interim DFS analysis
IMpower010: early OS data at interim DFS analysis PD-L1 TC ≥ 1% stage II-IIIA All-randomized stage II-IIIA ITT HR,a 0.77 (95% CI 0.51, 1.17) HR,a 0.99 (95% CI 0.73, 1.33) HR,a 1.07 (95% CI 0.80, 1.42) • OS data were immature at this pre-planned DFS interim analysis – OS in the ITT population was not
Slide 67: IMpower010: safety summary
IMpower010: safety summarya Atezolizumab BSC n (%) (n=495) (n=495) Any-cause AE 459 (92.7) 350 (70.7) Treatment-related AE 335 (67.7) – Grade 3-4 AE 108 (21.8) 57 (11.5) Treatment-related grade 3-4 AE 53 (10.7) – Serious AE 87 (17.6) 42 (8.5) Treatment-related serious AE 37 (7.5) – Grade 5 AE 8 (1.6
Slide 68: IMpower010: immune-mediated AEs
IMpower010: immune-mediated AEsa imAEs occuring in ≥1% of patients imAEs occuring in <1% of patients Atezolizumab BSC Atezolizumab BSC (n=495) (n=495) (n=495) (n=495) Any Grade Any Grade Any Grade Any Grade n (%) n (%) grade 3-4 grade 3-4 Grade 3-4 grade 3-4 Any immune-mediated AEs 256 (51.7)b 39 (7
Slide 69: IMpower010: conclusions
IMpower010: conclusions • IMpower010 is the first Phase III study of cancer immunotherapy to demonstrate DFS improvement in the adjuvant NSCLC setting after platinum-based chemotherapy – Adjuvant atezolizumab following complete resection and adjuvant chemotherapy showed statistically significant DFS
Slide 70: Acknowledgments
70 Acknowledgments • The patients and their families • The investigators and clinical study sites • This study is sponsored by F. Hoffman-La Roche Ltd • Medical writing assistance was provided by Samantha Santangelo, PhD, of Health Interactions and funded by F. Hoffman-La Roche Ltd Australia: A. Jos
Slide 71: Doing now what patients need next
Doing now what patients need next