Polatuzumab Vedotin -1L DLBCL RG7601 Venclexta + LDAC – 1L AML
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Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) 1 Changes to the development pipeline FY 2017 update New to phase I New to phase II New to phase III New to registration 6 NMEs: 1 NME: 1 NMEs: 1 AI following filing in US and EU: RG6109 NME - AML RG1678 bitopertin – beta thalassemia RG6152 baloxavir marboxil (CAP RG7601 Venclexta + Rituxan – r/r CLL RG6151 NME - asthma endonuclease inh) – influenza RG6171 SERD (3) – ER+ (HER2neg) mBC 2 AIs following filing in US: RG6174 NME – inflammatory diseases 6 AIs: RG435 Avastin – FL ovarian cancer RG6264 Perjeta + Herceptin FDC SC – RG3648 Xolair – nasal polyps RG3645 Lucentis 0.3mg PFS – DME/DR HER2+ eBC RG7421 Cotellic + Tecentriq – 1L BRAF WT RG7816 GABA-Aa5 PAM - autism melanoma 1 AI following filing in EU: RG7440 ipatasertib – 1L TNBC/HR+ BC RG1569 Actemra auto injector – RA 1 AIs: RG7446/RG7853 Tecentriq or Alecensa - 1L RG7446 Tecentriq + tazemetostat – r/r NSCLC Dx+ DLBCL RG7596 polatuzumab vedotin -1L DLBCL RG7601 Venclexta + LDAC – 1L AML Removed from phase I Removed from phase II Removed from phase III Removed from registration 3 NMEs: 1 AI: 1 NME: 3 AIs following US approval: RG6047 SERD (2) – ER+ (HER-neg) mBC RG3502 Kadcyla + Tecentriq – 2L Her2+ RG7417 lampalizumab – geographic atrophy RG435 Avastin - GBM RG7203 PDE10A inh – schizophrenia mBC RG7159 Gazyva – 1L FL RG7986 ADC – r/r NHL RG7204 Zelboraf – Erdheim-Chester disease 1 AI following US and EU approval: RG7853 Alecensa – 1L ALK+ NSCLC 1 NME following EU approval: RG1594 Ocrevus - PPMS + RMS 2 Status as of February 1, 2018 Roche Group development pipeline Phase I (43 NMEs + 23 AIs) Phase II (19 NMEs + 9 AIs) RG6264 Perjeta + Herceptin FDC SC HER2+ BC RG7802 CEA TCB ± Tecentriq solid tumors RG7388 idasanutlin§ polycythemia vera RG6026 CD20 TCB heme tumors RG7813 CEA IL2v FP* + Tecentriq solid tumors RG7421 Cotellic + Tecentriq ± taxane TNBC RG6058 TIGIT ± Tecentriq solid tumors RG7828 CD20 TDB ± Tecentriq heme tumors RG7440 ipatasertib TNBC neoadj RG6109 -- AML selicrelumab (CD40) + T solid tumors RG7596 polatuzumab vedotin r/r DLBCL + FL RG7876 RG6114 mPI3K alpha inh HR+ BC selicrelumab + vanucizumab solid tumors Venclexta + Rituxan DLBCL RG6146 BET inh combos solid + heme tumors RG7882 MUC16 ADC ovarian ca RG7601 Venclexta + Rituxan r/r FL RG6160 - multiple myeloma CHU Raf/MEK dual inh solid tumors Venclexta + azacitadine 1L MDS CHU glypican-3/CD3 biMAb solid tumors RG6171 SERD (3) ER+ (HER2neg) mBC RG7604 taselisib + letrozole (HER2-neg) BC neoadj RG6069 anti-fibrotic agent fibrosis RG6180 personalized cancer vaccine ± T oncology RG7686 codrituzumab liver cancer RG6107 C5 inh MAb PNH RG6185 pan-RAF inh + Cotellic solid tumors RG3637 lebrikizumab ± Esbriet IPF RG6151 - asthma emactuzumab + Tecentriq solid tumors RG6125 Cadherin-11 MAb RA RG7155 RG6174 - inflammatory diseases emactuzumab + selicrelumab solid tumors RG6149 ST2 MAb asthma RG7835 IgG-IL2 FP autoimmune diseases RG7159 anti-CD20 combos heme tumors RG7159 obinutuzumab lupus RG7880 IL-22Fc inflammatory diseases RG7386 FAP-DR5 biMAb solid tumors RG7625 Cat-S antag autoimmune diseases RG7990 - asthma Cotellic + Zelboraf + T melanoma RG7845 BTK inh RA, lupus, CSU RG7421 RG6004 HBV LNA HBV Cotellic + T 2L BRAF WT mM CHU nemolizumab** pruritus in dialysis patients RG6080 nacubactam bact. infections PRO VAP-1 inh inflammatory disease Tecentriq solid tumors RG7854 TLR7 agonist (3) HBV NOV TLR4 MAb autoimmune diseases Tecentriq NMIBC RG7861 anti-S. aureus TAC infectious diseases CHU URAT1 inh gout T-based Morpheus platform solid tumors RG7907 HBV Capsid (2) HBV RG1662 basmisanil CIAS T + Avastin + Cotellic 2/3L CRC RG7992 FGFR1/KLB MAb metabolic diseases RG1678 bitopertin beta thalassemia T ± Avastin ± chemo HCC, GC, PaC RG6000 - ALS RG6083 olesoxime SMA T + Cotellic solid tumors RG6029 Nav1.7 inh (2) pain RG6100 Tau MAb Alzheimer’s T + ipi/IFN solid tumors RG6042 ASO Huntington’s RG7314 balovaptan (V1a receptor antag) autism T + Tarceva/Alecensa NSCLC RG7446 RG7816 GABA Aa5 PAM autism RG7916 SMN2 splicer(2)*** SMA T + anti-CD20 combos heme tumors RG7906 - psychiatric disorders RG7935 α-synuclein MAb Parkinson's T ± lenalidomide ± daratumumab MM RG6147 - geographic atrophy RG3645 ranibizumab PDS wAMD T + K/HP HER2+ BC RG7945 - glaucoma RG7716 VEGF-ANG2 biMAb wAMD, DME T + HMA MDS CHU PTH1 recep. ago hypoparathyroidism T + radium 223 mCRPC CHU - hyperphosphatemia T + guadecitabine AML New Molecular Entity (NME) RG-No Roche/Genentech T + rucaparib ovarian ca Additional Indication (AI) CHU Chugai managed T + Gazyva/tazemetostat r/r DLBCL + FL Oncology PRO Proximagen managed Immunology NOV Novimmune managed RG7461 FAP IL2v FP combos solid tumors Infectious Diseases *INN: cergutuzumab amunaleukin Venclexta + Cotellic/idasanutlin AML CardioMetabolism **out-licensed to Galderma and Maruho for atopic dermatitis RG7601 Venclexta ± azacitadine r/r MDS Neuroscience *** Ph2 Pivotal Ophthalmology § FPI expected Q1 2018 3 RG7741 ChK1 inh solid tumors Other T=Tecentriq; TCB=T cell bispecific; TDB=T cell dependent bispecific Status as of February 1, 2018 Roche Group development pipeline Phase III (9 NMEs + 34 AIs) Registration (1 NME + 5 AIs) Kadcyla HER2+ BC adj Venclexta + Gazyva 1L CLL RG435 Avastin1 ovarian FL RG3502 Kadcyla + Perjeta HER2+ BC adj Venclexta + bortezomib MM RG1273 Perjeta + Herceptin2 HER2+ BC adj RG7601 Hemlibra hemophilia A w/o FVIII inh Venclexta + azacitidine 1L AML RG6013 Hemlibra3 hemophilia A FVIII inh RG6013 Hemlibra Q4W hemophilia A Venclexta + LDAC 1L AML RG7601 Venclexta + Rituxan r/r CLL RG7388 idasanutlin + chemo AML RG7604 taselisib + fulvestrant ER+(HER2-neg) mBC RG1569 Actemra auto injector4 RA ipatasertib + chemo 1L CRPC RG105 MabThera pemphigus vulgaris RG3645 Lucentis 0.3mg PFS1 DME/DR RG7440 ipatasertib 1L TNBC/HR+ BC RG1569 Actemra systemic sclerosis 1 US only Cotellic + Zelboraf + T 1L BRAFm melanoma RG3648 Xolair nasal polyps RG7421 Cotellic + T 1L BRAF WT melanoma etrolizumab ulcerative colitis 2 Approved in US RG7413 RG7596 polatuzumab vedotin 1L DLBCL etrolizumab Crohn’s 3 Approved in US; positive CHMP opinion Tecentriq NSCLC adj RG6152 baloxavir marboxil (CAP endonuclease inh) influenza Tecentriq MIBC adj RG1450 gantenerumab Alzheimer’s 4 EU only Tecentriq Dx+ 1L sq + non-sq SCLC RG6168 satralizumab (IL-6R Mab) NMO Tecentriq RCC adj RG6206 anti-myostatin adnectin DMD T + nab-paclitaxel 1L non-sq NSCLC RG7412 crenezumab Alzheimer’s T + chemo+ Avastin 1L ovarian cancer T + chemo + Avastin 1L non-sq NSCLC T + chemo + pemetrexed 1L non-sq NSCLC RG7446 T + nab-paclitaxel 1L sq NSCLC T + paclitaxel 1L TNBC T + nab-paclitaxel 1L TNBC T + nab-paclitaxel TNBC neoadj T + Avastin RCC New Molecular Entity (NME) RG-No Roche/Genentech T + Cotellic 3L CRC Additional Indication (AI) CHU Chugai managed Oncology RG1569 Branded as RoActemra (EU) T ± chemo 1L mUC Immunology T + chemo 1L extensive stage SCLC Infectious Diseases CardioMetabolism T + enzalutamide CRPC Neuroscience Ophthalmology RG7446/RG7853 Tecentriq or Alecensa 1L NSCLC Dx+ Other T=Tecentriq 4 Status as of February 1, 2018 NME submissions and their additional indications Projects currently in phase II and III gantenerumab RG1450 Alzheimer‘s basmisanil RG1662 CIAS bitopertin RG1678 beta thalassemia idasanutlin olesoxime VEGF/ANG2 biMAb RG7388 RG6083 RG7716 polycythemia vera SMA wAMD/DME ipatasertib Tau MAb Cadherin-11 MAb RG7440 RG6100 RG6125 1L CRPC Alzheimer’s RA ipatasertib anti-myostatin adnectin ST2 MAb RG7440 RG6206 RG6149 1L TNBC / HR+ BC DMD asthma baloxavir marboxil balovaptan ipatasertib etrolizumab RG6152 (CAP endonuclease inh) RG7440 RG7314 (V1 receptor antag) RG7413 ulcerative colitis influenza TNBC neoadj autism taselisib + fulvestrant polatuzumab vedotin crenezumab etrolizumab RG7604 PIK3CAmut ER+ RG7596 RG7412 RG7413 1L DLBCL Alzheimer’s Crohn’s (HER2-neg) mBC satralizumab Hemlibra polatuzumab vedotin SMN2 splicer(2) Cat S antag RG6013 RG6168 (IL-6R MAb, SA237) RG7596 RG7916 RG7625 hemophilia A FVIII non-inh r/r DLBCL & FL SMA autoimmune diseases neuromyelitis optica Hemlibra ✓ taselisib + letrozole Hemlibra idasanutlin α-synuclein MAb BTK inh RG6013 hemophilia A FVIII inh RG6013 RG7388 RG7604 ER+ (HER2-neg) RG7935 RG7845 hemophilia A, Q4W AML Parkinson’s autoimmune diseases pediatrics and adults BC neoadj 2017 2018 2019 2020 and beyond ✓ Indicates submission to health authorities has occurred New Molecular Entity (NME) CardioMetabolism Unless stated otherwise submissions are planned to occur in US and EU Additional Indication (AI) Neuroscience Oncology Ophthalmology 5 Immunology Other Status as of February 1, 2018 Infectious Diseases AI submissions for existing products Projects currently in phase II and III MabThera RG105 pemphigus vulgaris Actemra RG1569 systemic sclerosis Actemra auto injector (US) ranibizumab PDS RG1569 RG3645 RA/GCA wAMD Lucentis 0.3mg PFS (US) ✓ Venclexta + Rituxan (EU) ✓ Xolair RG36452 RG7601 RG3648 DME/DR r/r CLL nasal polyps Venclexta + azacitidine/LDAC Actemra auto injector (EU) ✓ RG7601 obinutuzumab RG1569 1L AML RG7159 RA lupus nephritis Tecentriq + Cotellic RG7446 Avastin (US) ✓ 3L CRC Cotellic + Tecentriq RG7446/ Tecentriq or Alecensa RG435 RG7421 GBM 1L BRAF WT melanoma RG7853 1L NSCLC Dx+ Tecentriq + chemo + Avastin RG7446 Avastin (US) ✓ 1L non-sq NSCLC Cotellic + Tecentriq + Zelboraf Kadcyla + Perjeta Tecentriq ± chemo RG435 RG7421 RG3502 RG7446 ovarian FL 1L BRAFmut melanoma HER2+ BC adj. 1L