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Pipeline Insight: Lymphomas, Multiple Myeloma & Myelodysplastic Syndromes - Optimization of clinical practice creates opportunities for emerging therapies Product Image

Pipeline Insight: Lymphomas, Multiple Myeloma & Myelodysplastic Syndromes - Optimization of clinical practice creates opportunities for emerging therapies

  • Published: April 2010
  • 243 pages
  • Datamonitor

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 READ MORE >

Overview
Catalyst
Summary
Executive Summary
Strategic scoping and focus
Datamonitor insight into the disease market
Contributing experts
Related reports
Upcoming related reports

1. Pipeline Overview and Dynamics
Key findings
Pipeline overview
Pipeline summary
The majority of drugs in late-phase development for lymphoma and multiple myeloma are targeted therapies.
Non-Hodgkin's lymphomas are targeted by drug developers more often than Hodgkin's lymphoma, multiple myeloma or myelodysplastic syndromes
Targeted therapies account for over half of non-Hodgkin's lymphoma drugs in clinical development
Drug developers have shown relatively little interest in myelodysplastic syndromes
Comparative forecasts
Drugs in late-phase development for non-Hodgkin's lymphomas will achieve combined sales of $676m by 2019
2. R&D Approach
Key findings
Clinical trial design in lymphomas, multiple myeloma and myelodysplastic syndromes
Patient selection
Increasingly significant in the era of targeted treatment
Clinical trial duration
Sufficient follow-up is necessary to establish true clinical benefit
The advent of novel therapies
Diversity of targeted therapies will require an evolution in clinical trial design
Clinical trial endpoints in hematological malignancies
Most oncology clinical trials designate multiple endpoints
Survival
Quality of life
Response rates
Toxicity
Time to progression
3. Non-Hodgkin's Lymphoma
Key findings
Disease overview - market potential
Definition of non-Hodgkin's lymphomas (NHL)
NHL is a broad classification given to a group of heterogeneous lymphomas
Patient segmentation
NHL is classified under the WHO classification system
NHL can follow an aggressive or indolent disease course
The Ann Arbor Staging Classification is of limited prognostic use
International Prognostic Index (IPI) for aggressive NHL
Immunophenotype differs between NHL subtypes
Several genetic abnormalities are linked to NHL
Molecular profiling in NHL
Epidemiology
Incidence of NHL will reach over 140,000 in the seven major markets by 2019
Incidence of non-Hodgkin's lymphoma (NHL) by subtype in the seven major markets
Distribution of NHL subtypes varies considerably across the seven major markets
Incidence of diffuse large B-cell lymphoma (DLBCL)
DLBCL is the most common aggressive lymphoma in the seven major markets
Incidence of follicular lymphoma (FL)
FL is the most common indolent lymphoma in the seven major markets
Incidence of cutaneous T-cell lymphoma (CTCL)
There are limited data on the incidence of CTCL
Current treatment options
Radiotherapy
Chemotherapy
First-line therapy
Treating relapsed/refractory disease
Stem cell transplantation
Current comparator therapies
Rituxan
Unmet need in NHL
More effective agents for the treatment of T-cell lymphomas
More effective therapies are required for relapsed/refractory disease
Agents with fewer side effects than currently available chemotherapies are required
Higher remission rate in indolent lymphomas
Target product profile versus current level of attainment
Pipeline analysis and forecasts
Pipeline summary
Comparative forecasts
Afinitor (everolimus; Novartis)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Afinitor is in Phase II trials as a maintenance therapy for poor-risk diffuse large B-cell lymphoma patients
Afinitor showed satisfactory activity in Phase II trial in pretreated lymphomas
Datamonitor drug assessment summary for Afinitor
Clinical and commercial attractiveness
Overall cure rates in diffuse large B-cell lymphoma (DLBCL) are high, but new treatments are needed for relapsed and refractory patients
Forecasts to 2019
Arzerra (ofatumumab; Genmab/GlaxoSmithKline)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Head-to-head study versus Rituxan initiated in diffuse large B-cell lymphoma
Genmab failed to demonstrate significant efficacy in pivotal Phase III trial in follicular lymphoma (FL)
Encouraging data in first-line follicular NHL in combination with CHOP
Clinical and commercial attractiveness
Failure of Phase III follicular NHL trial is a significant setback for Arzerra
Phase III trial head-to-head with Rituxan in DLBCL will increase the chances of commercial success
Arzerra will benefit from GlaxoSmithKline's expertise
Datamonitor's drug assessment summary for Arzerra
Forecasts to 2019
Avastin (bevacizumab; Genentech/Roche)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Clinical and commercial attractiveness
It is unclear whether the addition of Avastin to R-CHOP improves outcomes in DLBCL
Datamonitor drug assessment summary for Avastin
Forecasts to 2019
BiovaxID (Accentia Biopharmaceuticals)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Phase III study shows that maintenance BiovaxID prolongs disease-free survival in follicular lymphoma
Phase II data in mantle cell lymphoma show that BiovaxID treatment is feasible in B-cell-depleted patients
Clinical and commercial attractiveness
BiovaxID's positive Phase III data represent an important milestone for therapeutic vaccines...
...but clinical relevance of the data is doubtful
As a personalized vaccine, BiovaxID will have to overcome major economical and logistical barriers
Rituxan will provide fierce competition for BiovaxID in the first-line maintenance setting
Forecasts to 2019
Enzastaurin (Eli Lilly)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Enzastaurin shows marginal single-agent activity in relapsed/refractory DLBCL
Clinical and commercial attractiveness
The response rates in the Phase II trial are not very impressive
Enzastaurin may have to compete with Afinitor and Revlimid if approved as a maintenance therapy for DLBCL
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).
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.
Datamonitor drug assessment summary for enzastaurin
Forecasts to 2019
Forodesine (BioCryst Pharmaceuticals)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Clinical and commercial attractiveness
Better therapies are needed to treat relapsed/refractory cutaneous T-cell lymphoma
Datamonitor drug assessment summary for forodesine
Forecasts to 2019
Pixuvri (pixantrone; Cell Therapeutics)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Clinical and commercial attractiveness
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...
Cell therapeutics will have to decide if they want to instigate further trials
Forecasts to 2019
Revlimid (lenalidomide; Celgene)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Phase III trial of Revlimid in diffuse large B-cell lymphoma was planned in December 2008
Revlimid shows single-agent activity in relapsed/refractory DLBCL patients
Revlimid has also demonstrated single-agent activity in mantle cell lymphoma (MCL)
Revlimid is in Phase II trials for the treatment of indolent lymphomas
Clinical and commercial attractiveness
There is high unmet need for relapsed mantle cell lymphoma patients making Revlimid's approval likely in this indication
Celgene may be having problems with the maintenance trial for DLBCL
Datamonitor drug assessment summary for Revlimid
Forecasts to 2019
Velcade (bortezomib; Takeda/Johnson & Johnson)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
The combination of Velcade (bortezomib) with Rituxan (rituximab) is active in the first-line treatment of indolent non-Hodgkin's lymphomas (NHL)
Takeda has been investigating combination regimens containing Velcade in the treatment of lymphoma
Clinical and commercial attractiveness
Physicians are interested in less toxic treatments for follicular lymphoma
It seems likely that Velcade will gain approval for the treatment of follicular lymphoma
Datamonitor drug assessment summary for Velcade
Forecasts to 2019
4. Hodgkin's Lymphoma
Key findings
Disease overview - market potential
Definition of Hodgkin's lymphomas (HL)
HL is characterized by the presence of Reed-Sternberg cells
Patient segmentation
There are two distinct types of Hodgkin's Lymphoma (HL)
Classical Hodgkin's lymphoma (CHL)
Nodular lymphocyte predominant Hodgkin's lymphoma (NLPHL)
Staging and risk assessment
Epidemiology
Incidence of HL will reach over 18,000 in the seven major markets by 2019
Current treatment options
Initial therapy is a combination of radiotherapy and chemotherapy
Autologous stem cell transplantation is recommended for relapsed patients
Treatment outcomes are good for most patients
Current comparator therapies
Unmet need in Hodgkin's lymphoma
More tolerable agents
Treatments for relapsed patients
Treatments for elderly patients
Target product profile versus current level of attainment
Pipeline analysis and forecasts
Pipeline summary
Comparative forecasts
Brentuximab vedotin (SGN-35; Seattle Genetics/Takeda)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Clinical and commercial attractiveness
The greatest unmet need in Hodgkin's lymphoma is in the relapsed/refractory setting
Key opinion leaders were positive about brentuximab vedotin's potential as a treatment for Hodgkin's lymphoma
Collaboration between Seattle Genetics and Millennium Pharmaceuticals will see brentuximab vedotin rapidly brought to market
Datamonitor drug assessment summary for brentuximab vedotin
Forecasts to 2019
Panobinostat (LBH589B; Novartis)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Clinical and commercial attractiveness
Novartis is targeting a small niche indication in order to gain approval for panobinostat
The Phase II data have shown that panobinostat has some activity in heavily pretreated patients
Novartis has extensive experience in niche hematology indications
Datamonitor drug assessment summary for panobinostat
Forecasts to 2019
5. Multiple Myeloma
Key findings
Disease overview - market potential
Definition of multiple myeloma (MM)
MM is a common hematological malignancy
Genetic abnormalities are characteristic of multiple myeloma cells
Patient segmentation
Disease classification
The International Staging System improves disease assessment
Epidemiology
Incidence of multiple myeloma will reach over 47,000 in the seven major markets by 2019
Current treatment options
Treatment choice depends on transplant eligibility and patient age
The approval of three novel drugs has revolutionized treatment
Current comparator therapies
Revlimid
Unmet need in multiple myeloma
Drug toxicities limit disease management
Optimal sequencing of drugs across different lines of therapy remains undetermined
Myeloma remains incurable as disease relapse is inevitable
Target product profile versus current level of attainment
Revlimid's impressive trial results underlie its leading second-line status
Pipeline analysis and forecasts
Pipeline summary
Comparative forecasts
Carfilzomib (Proteolix/Onyx Pharmaceuticals)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Clinical and commercial attractiveness
Carfilzomib is a next generation proteasome inhibitor aiming to usurp Velcade
A future head-to-head study with Velcade would enhance carfilzomib's commercial potential
Datamonitor drug assessment summary
Forecasts to 2019
Panobinostat (LBH589B; Novartis)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Clinical and commercial attractiveness
The synergistic effect between panobinostat and Velcade shown in Phase Ib trials is promising
Panobinostat would face strong competition in this indication
Datamonitor drug assessment summary for panobinostat
Forecasts to 2019
Perifosine (AEterna Zentaris/Keryx Pharmaceuticals)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Clinical and commercial attractiveness
Combination of perifosine and Velcade showed promising activity in heavily pretreated patients but further results are necessary to show the effect of perifosine
Competition will make it harder to gain significant market share
Datamonitor drug assessment summary
Forecasts to 2019
Zolinza (vorinostat; Merck & Co)
Drug overview
Drug profile
Key historical events
SWOT analysis
Clinical trial data
Phase I trial data suggest that Zolinza in combination with Velcade is active and generally well tolerated in the treatment of relapsed/refractory MM
Clinical and commercial attractiveness
Datamonitor drug assessment summary
Forecasts to 2019
6. Myelodysplastic syndromes
Key findings
Disease overview - market potential
Definition of myelodysplastic syndromes (MDS)
MDS constitute a heterogeneous group of hematological malignancies
Hallmark of MDS - a hypercellular bone marrow with dysplastic changes in combination with peripheral cytopenias
Hypercellularity
Dysplasia
Chromosomal abnormalities are common but little is known about the molecular basis of the disease
Patient segmentation
The classification of MDS
French American British (FAB) System
Limitations of the FAB system
World Health Organization (WHO) System
Limitations of the WHO classification system
International Prognostic Scoring System (IPSS)
The IPSS classification system is the current standard for evaluating prognosis in MDS patients
Limitations of the IPSS system
Epidemiology
Incidence of myelodysplastic syndromes will exceed 33,000 in the seven major markets by 2019
There are limited data on the incidence of MDS
Current treatment options
The aim of treatment differs in lower- and higher-risk patients
The choice of therapy is not solely dependent on a patient's IPSS risk group
Non-chemotherapy low-intensity agents
Low-intensity chemotherapy
Hematopoietic stem cell transplantation (HSCT)
High-intensity chemotherapy
Current therapies
Vidaza
Unmet needs in MDS
Limited pipeline activity
A better understanding of the molecular pathogenesis
Low-intensity therapies with improved efficacy and better toxicity profiles
Target product profile versus current level of attainment
Vidaza
Bibliography
Journals
Websites
Datamonitor reports
Other
APPENDIX
Methodology
Datamonitor forecast methodology
Epidemiology forecasts
Product forecasts
Datamonitor drug assessment scorecard
About Datamonitor
About Datamonitor Healthcare
About the Disease analysis team
Datamonitor consulting
Disclaimer

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