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Pipeline Insight: Lymphomas, Multiple Myeloma & Myelodysplastic Syndromes - Optimization of clinical practice creates opportunities for emerging therapies
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Introduction
The commercial success of Rituxan in the treatment of NHL and Velcade and Revlimid in the treatment of MM has attracted the interest of pharmaceutical companies to these markets. There a.....
Introduction The commercial success of Rituxan in the treatment of NHL and Velcade and Revlimid in the treatment of MM has attracted the interest of pharmaceutical companies to these markets. There are 173 drugs in clinical development for these indications, the majority of which are molecular targeted therapies (MTTs). This contrasts with HL and MDS where there is limited pipeline activity. Scope *Examination of key pipeline candidates with in-depth clinical and commercial profiles of Phase III candidates *Seven major pharmaceutical market sales forecasts for Phase III pipeline products through to 2019 with product-specific assumptions Highlights There are currently 107 drugs in clinical development for NHL, of which 12 are in late phase development. This high R&D activity is due to the diverse nature of the diseases and the success of therapies such as Rituxan in these indications. Targeted therapies account for over half of drugs in development for NHL. There are currently 15 drugs in clinical development for HL, of which 3 are in late phase development. Unmet needs persists in HL but are confined to relapsed patients and elderly patients, which are relatively small patient populations. There are currently 66 drugs in clinical development for MM, of which 8 are in late phase development. MM is an incurable disease and there is a need for better and less toxic therapies across all lines of treatment. Reasons to Purchase *Segmentation and analysis of the current pipeline by developmental phase, drug class and company *Insight and analysis of market potential including commercial opportunity, epidemiology and discussion of unmet needs [Studien Infos ausblenden] |
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Overview 1 Catalyst 1 Summary 1 ABOUT DATAMONITOR HEALTHCARE 2 About the Oncology pharmaceutical analysis team 2 Executive Summary 3 Strategic scoping and focus 3 Datamonitor insight into the disease market 3 Contributing experts 4 Related reports 5 Upcoming related reports 5 Table of Contents 6 1. Pipeline Overview and Dynamics 7 Key findings 7 Pipeline overview 8 Pipeline summary 8 The majority of drugs in late-phase development for lymphoma and multiple myeloma are targeted therapies. 8 Non-Hodgkin's lymphomas are targeted by drug developers more often than Hodgkin's lymphoma, multiple myeloma or myelodysplastic syndromes 9 Targeted therapies account for over half of non-Hodgkin's lymphoma drugs in clinical development 10 Drug developers have shown relatively little interest in myelodysplastic syndromes 14 Comparative forecasts 15 Drugs in late-phase development for non-Hodgkin's lymphomas will achieve combined sales of $676m by 2019 15 2. R&D Approach 17 Key findings 17 Clinical trial design in lymphomas, multiple myeloma and myelodysplastic syndromes 17 Patient selection 17 Increasingly significant in the era of targeted treatment 17 Clinical trial duration 17 Sufficient follow-up is necessary to establish true clinical benefit 17 The advent of novel therapies 18 Diversity of targeted therapies will require an evolution in clinical trial design 18 Clinical trial endpoints in hematological malignancies 18 Most oncology clinical trials designate multiple endpoints 18 Survival 19 Quality of life 19 Response rates 19 Toxicity 19 Time to progression 19 3. Non-Hodgkin's Lymphoma 21 Key findings 21 Disease overview - market potential 21 Definition of non-Hodgkin's lymphomas (NHL) 21 NHL is a broad classification given to a group of heterogeneous lymphomas 21 Patient segmentation 22 NHL is classified under the WHO classification system 22 NHL can follow an aggressive or indolent disease course 22 The Ann Arbor Staging Classification is of limited prognostic use 23 International Prognostic Index (IPI) for aggressive NHL 23 Immunophenotype differs between NHL subtypes 24 Several genetic abnormalities are linked to NHL 25 Molecular profiling in NHL 26 Epidemiology 27 Incidence of NHL will reach over 140,000 in the seven major markets by 2019 27 Incidence of non-Hodgkin's lymphoma (NHL) by subtype in the seven major markets 30 Distribution of NHL subtypes varies considerably across the seven major markets 30 Incidence of diffuse large B-cell lymphoma (DLBCL) 30 DLBCL is the most common aggressive lymphoma in the seven major markets 30 Incidence of follicular lymphoma (FL) 32 FL is the most common indolent lymphoma in the seven major markets 32 Incidence of cutaneous T-cell lymphoma (CTCL) 33 There are limited data on the incidence of CTCL 33 Current treatment options 35 Radiotherapy 36 Chemotherapy 36 First-line therapy 37 Treating relapsed/refractory disease 38 Stem cell transplantation 38 Current comparator therapies 38 Rituxan 38 Unmet need in NHL 41 More effective agents for the treatment of T-cell lymphomas 41 More effective therapies are required for relapsed/refractory disease 42 Agents with fewer side effects than currently available chemotherapies are required 42 Higher remission rate in indolent lymphomas 42 Target product profile versus current level of attainment 42 Pipeline analysis and forecasts 46 Pipeline summary 46 Comparative forecasts 48 Afinitor (everolimus; Novartis) 51 Drug overview 51 Drug profile 52 Key historical events 53 SWOT analysis 54 Clinical trial data 55 Afinitor is in Phase II trials as a maintenance therapy for poor-risk diffuse large B-cell lymphoma patients 55 Afinitor showed satisfactory activity in Phase II trial in pretreated lymphomas 55 Datamonitor drug assessment summary for Afinitor 57 Clinical and commercial attractiveness 57 Overall cure rates in diffuse large B-cell lymphoma (DLBCL) are high, but new treatments are needed for relapsed and refractory patients 57 Forecasts to 2019 59 Arzerra (ofatumumab; Genmab/GlaxoSmithKline) 59 Drug overview 59 Drug profile 60 Key historical events 61 SWOT analysis 62 Clinical trial data 63 Head-to-head study versus Rituxan initiated in diffuse large B-cell lymphoma 64 Genmab failed to demonstrate significant efficacy in pivotal Phase III trial in follicular lymphoma (FL) 65 Encouraging data in first-line follicular NHL in combination with CHOP 66 Clinical and commercial attractiveness 67 Failure of Phase III follicular NHL trial is a significant setback for Arzerra 67 Phase III trial head-to-head with Rituxan in DLBCL will increase the chances of commercial success 67 Arzerra will benefit from GlaxoSmithKline's expertise 68 Datamonitor's drug assessment summary for Arzerra 68 Forecasts to 2019 69 Avastin (bevacizumab; Genentech/Roche) 69 Drug overview 69 Drug profile 70 Key historical events 70 SWOT analysis 72 Clinical trial data 73 Clinical and commercial attractiveness 73 It is unclear whether the addition of Avastin to R-CHOP improves outcomes in DLBCL 73 Datamonitor drug assessment summary for Avastin 75 Forecasts to 2019 76 BiovaxID (Accentia Biopharmaceuticals) 76 Drug overview 76 Drug profile 77 Key historical events 78 SWOT analysis 79 Clinical trial data 80 Phase III study shows that maintenance BiovaxID prolongs disease-free survival in follicular lymphoma 80 Phase II data in mantle cell lymphoma show that BiovaxID treatment is feasible in B-cell-depleted patients 81 Clinical and commercial attractiveness 82 BiovaxID's positive Phase III data represent an important milestone for therapeutic vaccines... 82 ...but clinical relevance of the data is doubtful 82 As a personalized vaccine, BiovaxID will have to overcome major economical and logistical barriers 83 Rituxan will provide fierce competition for BiovaxID in the first-line maintenance setting 83 Forecasts to 2019 83 Enzastaurin (Eli Lilly) 84 Drug overview 84 Drug profile 84 Key historical events 85 SWOT analysis 86 Clinical trial data 87 Enzastaurin shows marginal single-agent activity in relapsed/refractory DLBCL 87 Clinical and commercial attractiveness 88 The response rates in the Phase II trial are not very impressive 88 Enzastaurin may have to compete with Afinitor and Revlimid if approved as a maintenance therapy for DLBCL 89 Eli Lilly would have to overcome physician skepticism about the role of maintenance therapies in the treatment of DLBCL if enzastaurin gained approval for this indication. There is a high cure rate for DLBCL and therefore the concept of using maintenance therapy for this disease remains questionable. Maintenance therapy is widely used in the treatment of indolent lymphomas like follicular lymphoma, but currently not commonly used to treat aggressive lymphomas like DLBCL (Datamonitor, Stakeholder Insight 2009: Non-Hodgkin's lymphomas December 2009, DMHC2532). 89 Furthermore, enzastaurin could face considerable competition from Afinitor (everolimus; Novartis) or Revlimid (lenalidomide; Celgene) because these drugs are also in development as maintenance therapies for relapsed or refractory DLBCL. 89 Datamonitor drug assessment summary for enzastaurin 90 Forecasts to 2019 91 Forodesine (BioCryst Pharmaceuticals) 91 Drug overview 91 Drug profile 92 Key historical events 93 SWOT analysis 94 Clinical trial data 95 Clinical and commercial attractiveness 97 Better therapies are needed to treat relapsed/refractory cutaneous T-cell lymphoma 97 Datamonitor drug assessment summary for forodesine 97 Forecasts to 2019 99 Pixuvri (pixantrone; Cell Therapeutics) 100 Drug overview 100 Drug profile 100 Key historical events 101 SWOT analysis 102 Clinical trial data 103 Clinical and commercial attractiveness 104 FDA approval for Pixuvri now unlikely if the drug now has a brand name this has to be consistent through the whole of the report... 104 Cell therapeutics will have to decide if they want to instigate further trials 104 Forecasts to 2019 105 Revlimid (lenalidomide; Celgene) 105 Drug overview 105 Drug profile 106 Key historical events 107 SWOT analysis 108 Clinical trial data 108 Phase III trial of Revlimid in diffuse large B-cell lymphoma was planned in December 2008 110 Revlimid shows single-agent activity in relapsed/refractory DLBCL patients 110 Revlimid has also demonstrated single-agent activity in mantle cell lymphoma (MCL) 111 Revlimid is in Phase II trials for the treatment of indolent lymphomas 111 Clinical and commercial attractiveness 113 There is high unmet need for relapsed mantle cell lymphoma patients making Revlimid's approval likely in this indication 113 Celgene may be having problems with the maintenance trial for DLBCL 113 Datamonitor drug assessment summary for Revlimid 113 Forecasts to 2019 115 Velcade (bortezomib; Takeda/Johnson & Johnson) 115 Drug overview 115 Drug profile 116 Key historical events 117 SWOT analysis 118 Clinical trial data 119 The combination of Velcade (bortezomib) with Rituxan (rituximab) is active in the first-line treatment of indolent non-Hodgkin's lymphomas (NHL) 120 Takeda has been investigating combination regimens containing Velcade in the treatment of lymphoma 121 Clinical and commercial attractiveness 123 Physicians are interested in less toxic treatments for follicular lymphoma 123 It seems likely that Velcade will gain approval for the treatment of follicular lymphoma 124 Datamonitor drug assessment summary for Velcade 124 Forecasts to 2019 125 4. Hodgkin's Lymphoma 126 Key findings 126 Disease overview - market potential 126 Definition of Hodgkin's lymphomas (HL) 126 HL is characterized by the presence of Reed-Sternberg cells 126 Patient segmentation 127 There are two distinct types of Hodgkin's Lymphoma (HL) 127 Classical Hodgkin's lymphoma (CHL) 128 Nodular lymphocyte predominant Hodgkin's lymphoma (NLPHL) 128 Staging and risk assessment 128 Epidemiology 129 Incidence of HL will reach over 18,000 in the seven major markets by 2019 129 Current treatment options 130 Initial therapy is a combination of radiotherapy and chemotherapy 130 Autologous stem cell transplantation is recommended for relapsed patients 131 Treatment outcomes are good for most patients 131 Current comparator therapies 131 Unmet need in Hodgkin's lymphoma 132 More tolerable agents 132 Treatments for relapsed patients 132 Treatments for elderly patients 133 Target product profile versus current level of attainment 133 Pipeline analysis and forecasts 135 Pipeline summary 135 Comparative forecasts 137 Brentuximab vedotin (SGN-35; Seattle Genetics/Takeda) 139 Drug overview 139 Drug profile 140 Key historical events 141 SWOT analysis 142 Clinical trial data 143 Clinical and commercial attractiveness 143 The greatest unmet need in Hodgkin's lymphoma is in the relapsed/refractory setting 143 Key opinion leaders were positive about brentuximab vedotin's potential as a treatment for Hodgkin's lymphoma 144 Collaboration between Seattle Genetics and Millennium Pharmaceuticals will see brentuximab vedotin rapidly brought to market 144 Datamonitor drug assessment summary for brentuximab vedotin 145 Forecasts to 2019 146 Panobinostat (LBH589B; Novartis) 146 Drug overview 146 Drug profile 147 Key historical events 148 SWOT analysis 149 Clinical trial data 150 Clinical and commercial attractiveness 151 Novartis is targeting a small niche indication in order to gain approval for panobinostat 151 The Phase II data have shown that panobinostat has some activity in heavily pretreated patients 151 Novartis has extensive experience in niche hematology indications 151 Datamonitor drug assessment summary for panobinostat 152 Forecasts to 2019 153 5. Multiple Myeloma 154 Key findings 154 Disease overview - market potential 154 Definition of multiple myeloma (MM) 154 MM is a common hematological malignancy 154 Genetic abnormalities are characteristic of multiple myeloma cells 154 Patient segmentation 156 Disease classification 156 The International Staging System improves disease assessment 157 Epidemiology 159 Incidence of multiple myeloma will reach over 47,000 in the seven major markets by 2019 159 Current treatment options 160 Treatment choice depends on transplant eligibility and patient age 160 The approval of three novel drugs has revolutionized treatment 161 Current comparator therapies 162 Revlimid 162 Unmet need in multiple myeloma 165 Drug toxicities limit disease management 166 Optimal sequencing of drugs across different lines of therapy remains undetermined 166 Myeloma remains incurable as disease relapse is inevitable 166 Target product profile versus current level of attainment 167 Revlimid's impressive trial results underlie its leading second-line status 167 Pipeline analysis and forecasts 169 Pipeline summary 169 Comparative forecasts 171 Carfilzomib (Proteolix/Onyx Pharmaceuticals) 173 Drug overview 173 Drug profile 173 Key historical events 174 SWOT analysis 175 Clinical trial data 176 Clinical and commercial attractiveness 178 Carfilzomib is a next generation proteasome inhibitor aiming to usurp Velcade 178 A future head-to-head study with Velcade would enhance carfilzomib's commercial potential 178 Datamonitor drug assessment summary 179 Forecasts to 2019 180 Panobinostat (LBH589B; Novartis) 180 Drug overview 180 Drug profile 181 Key historical events 182 SWOT analysis 183 Clinical trial data 184 Clinical and commercial attractiveness 184 The synergistic effect between panobinostat and Velcade shown in Phase Ib trials is promising 184 Panobinostat would face strong competition in this indication 185 Datamonitor drug assessment summary for panobinostat 185 Forecasts to 2019 186 Perifosine (AEterna Zentaris/Keryx Pharmaceuticals) 186 Drug overview 186 Drug profile 186 Key historical events 188 SWOT analysis 189 Clinical trial data 190 Clinical and commercial attractiveness 193 Combination of perifosine and Velcade showed promising activity in heavily pretreated patients but further results are necessary to show the effect of perifosine 193 Competition will make it harder to gain significant market share 193 Datamonitor drug assessment summary 194 Forecasts to 2019 195 Zolinza (vorinostat; Merck & Co) 195 Drug overview 195 Drug profile 196 Key historical events 197 SWOT analysis 198 Clinical trial data 199 Phase I trial data suggest that Zolinza in combination with Velcade is active and generally well tolerated in the treatment of relapsed/refractory MM 199 Clinical and commercial attractiveness 200 Datamonitor drug assessment summary 201 Forecasts to 2019 202 6. Myelodysplastic syndromes 203 Key findings 203 Disease overview - market potential 204 Definition of myelodysplastic syndromes (MDS) 204 MDS constitute a heterogeneous group of hematological malignancies 204 Hallmark of MDS - a hypercellular bone marrow with dysplastic changes in combination with peripheral cytopenias 204 Hypercellularity 204 Dysplasia 205 Chromosomal abnormalities are common but little is known about the molecular basis of the disease 206 Patient segmentation 207 The classification of MDS 207 French American British (FAB) System 207 Limitations of the FAB system 208 World Health Organization (WHO) System 209 Limitations of the WHO classification system 210 International Prognostic Scoring System (IPSS) 210 The IPSS classification system is the current standard for evaluating prognosis in MDS patients 210 Limitations of the IPSS system 212 Epidemiology 212 Incidence of myelodysplastic syndromes will exceed 33,000 in the seven major markets by 2019 212 There are limited data on the incidence of MDS 213 Current treatment options 214 The aim of treatment differs in lower- and higher-risk patients 214 The choice of therapy is not solely dependent on a patient's IPSS risk group 214 Non-chemotherapy low-intensity agents 215 Low-intensity chemotherapy 215 Hematopoietic stem cell transplantation (HSCT) 216 High-intensity chemotherapy 216 Current therapies 216 Vidaza 216 Unmet needs in MDS 220 Limited pipeline activity 221 A better understanding of the molecular pathogenesis 221 Low-intensity therapies with improved efficacy and better toxicity profiles 221 Target product profile versus current level of attainment 222 Vidaza 222 Bibliography 224 Journals 224 Websites 233 Datamonitor reports 237 Other 237 APPENDIX 238 Methodology 238 Datamonitor forecast methodology 238 Epidemiology forecasts 238 Product forecasts 238 Datamonitor drug assessment scorecard 239 About Datamonitor 240 About Datamonitor Healthcare 240 About the Disease analysis team 240 Datamonitor consulting 241 Disclaimer 243 [Inhaltsverzeichnis ausblenden] |
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