Pipeline Insight: Hematological Malignancies Companies target niche indications to facilitate market entry : Market Research Report

Pipeline Insight: Hematological Malignancies Companies target niche indications to facilitate market entry

Published by: Datamonitor

Published: Apr. 17, 2009 - 373 Pages

ABOUT DATAMONITOR HEALTHCARE: About the Oncology pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY: Scope of the analysis; Datamonitor insight into the hematological malignancies market; Late-phase pipeline forecasts; Related reports; Upcoming reports
CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS: Key findings; Pipeline overview; The large number of pipeline molecular-targeted therapies, highlights the growing R&D interest in this innovative drug class; Comparative forecasts; Datamonitor pipeline assessment summary; Key Phase II hematological malignancies pipeline drugs; Key companies involved in the hematological malignancies pipeline; Biogen Idec; As developer's of the current blockbuster Rituxan (rituximab), Biogen Idec has extensive experience in the hematological malignancies market; Cluster of differentiation (CD) drugs remain Biogen Idec's specialty; Novartis; Novartis enjoys considerable market share achieved from the extensive use of Gleevec; Novartis's long-term commitment to the hematological malignancies market is evident from its extensive pipeline; Wyeth (now part of Pfizer); Wyeth's acquisition by Pfizer should help raise the company's profile in oncology; Key R&D company strategies; Targeting small, niche patient populations is an increasingly popular R&D strategy; The development of second-generation products that follow-on from established marketed drugs eases market entry; Companies aim to enhance the sales potential of their marketed drugs by pursuing an additional indication in hematological malignancies
CHAPTER 3 HEMATOLOGICAL MALIGNANCIES - MARKET POTENTIAL: Key findings; Definition and segmentation of hematological malignancies; Leukemia; Lymphoma; Multiple myeloma; Myelodysplastic syndromes; Epidemiology; Seven major markets; Leukemias; Lymphomas; Multiple myeloma; Myelodysplastic syndromes; Rest of the world; Current treatment options; Leukemia; Acute myeloid leukemia; Acute lymphoblastic leukemia; Chronic myeloid leukemia; Chronic lymphocytic leukemia; Lymphoma; Non-Hodgkin's lymphoma; Hodgkin's disease; Multiple myeloma; Myelodysplastic syndromes; Current standard of care and comparator therapies; Unmet need in the hematological malignancies; Leukemia unmet needs; Acute myeloid leukemia and acute lymphoblastic leukemia; Chronic myeloid leukemia; Chronic lymphocytic leukemia; Lymphoma unmet needs; Non-Hodgkin's lymphoma; Hodgkin's disease; Multiple myeloma unmet needs; Multiple myeloma remains largely incurable; Optimal sequencing of drugs across different lines of therapy remains undetermined; Drugs with lower toxicities required for use in all myeloma patients; Myelodysplastic syndromes unmet needs; A better understanding of the molecular pathogenesis; Low-intensity therapies with improved efficacy and better toxicity profiles; Low-intensity therapies to improve symptoms of anemia and quality of life
CHAPTER 4 R&D APPROACH: Key findings; Clinical trial design in the hematological malignancies; 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 oncology; Most oncology clinical trials designate multiple endpoints; Survival; Quality of life; Tumor response rates; Toxicity; Time to tumor progression
CHAPTER 5 CYTOTOXIC THERAPIES ANALYSIS AND FORECASTS: Key findings; Overview of cytotoxic therapies; Cytotoxic therapies by ATC class; L1A - Alkylating agents; L1B - Antimetabolites; L1C - Vinca alkaloids and other plant-derived products; L1D - Antineoplastic antibiotics; L1X2 - Platinum compounds; Report classification of pipeline cytotoxic therapies; Mitotic inhibitors; DNA-interactive agents; Definition of current comparator therapy; Late-phase pipeline analysis and forecasts; Pipeline summary; Late-phase pipeline of cytotoxic therapies; Comparative forecasts; Amonafide (ASA1413; Antisoma); Drug overview; Drug profile; Key historical events; Clinical trial data; Amonafide produces durable responses in secondary AML patients; Datamonitor comments; Amonafide's target indication represents a small population with high unmet needs; Datamonitor drug assessment summary for amonafide; Forecasts to 2018; Marqibo (liposomal vincristine; Hana Biosciences); Drug overview; Drug profile; Key historical events; Clinical trial data; Development in non-Hodgkin's lymphoma is no longer being pursued; Trials in acute lymphoblastic leukemia hold promise for Marqibo; Datamonitor comments; Shifting the focus to acute lymphoblastic leukemia may offer a quicker route to market for Marqibo; Datamonitor drug assessment summary for Marqibo; Forecasts to 2018; Onrigin (laromustine; Vion Pharmaceuticals); Drug overview; Drug profile; Key historical events; Clinical trial data; FDA lifts hold on Onrigin Phase III acute myeloid leukemia trial; Single agent Onrigin appears effective in poor risk acute myeloid leukemia; High-risk myelodysplastic syndrome patients may also benefit from Onrigin monotherapy; Onrigin and Temodar in hematological malignancies appears to be a rational combination; Vion discontinues Onrigin development in chronic lymphocytic lymphoma to focus on acute myeloid leukemia; Datamonitor comments; Onrigin demonstrates promise for relapsed/refractory acute myeloid leukemia; Vion could seek a collaborative agreement with a more experienced oncology partner; Datamonitor drug assessment summary for Onrigin; Forecasts to 2018; Pixantrone (BBR-2778; Cell Therapeutics); Drug overview; Drug profile; Key historical events; Clinical trial data; Pixantrone US submission aimed for 2009 based on positive preliminary Phase III data; Phase II data for first-line use of pixantrone in diffuse large B-cell lymphoma show lower cardiotoxicity; Promising Phase II data reported for use of pixantrone in relapsed aggressive non-Hodgkin's lymphoma; Use of pixantrone for indolent non-Hodgkin's lymphoma; Datamonitor comments; Problems associated with trying to replace genericized drugs must be overcome; EU compassionate use program will raise pixantrone's profile and physician awareness; Datamonitor drug assessment summary for pixantrone; Forecasts to 2018
CHAPTER 6 IMMUNOTHERAPEUTIC AGENTS ANALYSIS AND FORECASTS: Key findings; Overview of immunotherapeutic agents; Antibody-based technologies are an effective anticancer approach; Therapeutic cancer vaccines; Definition of current comparator therapy; Rituxan (Rituximab; Biogen Idec/Genentech/Roche) - comparator for pipeline immunotherapies; Late-phase pipeline analysis and forecasts; Pipeline summary; Late-phase pipeline of immunotherapeutic agents; Comparative forecasts; Arzerra (ofatumumab; Genmab/GlaxoSmithKline); Drug overview; Drug profile; Key historical events; Clinical trial data; Promising Phase III trial results supports filing for refractory chronic lymphocytic leukemia; Genmab initiates a pivotal Phase III trial in follicular non-Hodgkin's lymphoma; Genmab/GlaxoSmithKline are investigating Arzerra in the first-line follicular lymphoma setting; Datamonitor comments; Genmab/GlaxoSmithKline's commercial strategy may improve Arzerra's chances of success in the non-Hodgkin's lymphoma market; Targeting underserved chronic lymphocytic leukemia patients may enhance Arzerra's uptake in the market; Datamonitor drug assessment summary for Arzerra; Forecasts to 2018; BiovaxID (Accentia Biopharmaceuticals); Drug overview; Drug profile; Key historical events; Clinical trial data; Phase III pivotal trial in follicular lymphoma halted early to seek accelerated approval; Possible association between a specific negative chromosomal translocation following vaccination and disease-free survival; Phase II results of BiovaxID in mantle cell lymphoma are promising; Datamonitor comments; Biovest would greatly benefit from an experienced oncology partner for BiovaxID commercialization; BiovaxID's price should reflect the anticipated competition and current treatment costs; Datamonitor drug assessment summary for BiovaxID; Forecasts to 2018; Galiximab (Anti-CD80 MAb; Biogen Idec); Drug overview; Drug profile; Key historical events; Clinical trial data; Randomized Phase III trial will compare survival of galiximab plus Rituxan with Rituxan alone in relapsed/refractory follicular lymphoma patients; Phase II results show galiximab and Rituxan can be safely combined and produce promising response rates in follicular lymphoma patients; Datamonitor comments; Biogen Idec in a strong position to successfully market galiximab; Lack of standard-of-care for second-line treatment of follicular lymphoma will aid galiximab's approval prospects; Biogen Idec will need to demonstrate the value of a combination of galiximab and Rituxan to payers; Cluster of differentiation (CD) drugs have become Biogen Idec's specialty; Datamonitor drug assessment summary for galiximab; Forecasts to 2018; Inotuzumab ozogamicin (Wyeth, now part of Pfizer); Drug overview; Drug profile; Key historical events; Clinical trial data; Results of a Phase I/II monotherapy study shows inotuzumab and Rituxan combination is active and tolerable in relapsed non-Hodgkin's lymphoma patients; Datamonitor comments; Can the inotuzumab and Rituxan combination replace conventional chemotherapy regimens?; Rituxan's success in non-Hodgkin's lymphoma raises the barrier to market entry; Pfizer's acquisition of Wyeth will help strengthen inotuzumab's potential launch in non-Hodgkin's lymphoma; Datamonitor drug assessment summary for inotuzumab; Forecasts to 2018; Lumiliximab (Anti-CD23 MAb; Biogen Idec); Drug overview; Drug profile; Key historical events; Clinical trial data; The addition of lumiliximab to the FCR regimen may produce a higher response rate without additional toxicity; Datamonitor comments; Lumiliximab on course to become an established addition to the standard treatment for chronic lymphocytic leukemia; Biogen Idec should look to investigate lumiliximab as a maintenance therapy; Cluster of differentiation (CD) drugs have become Biogen Idec's specialty; Datamonitor drug assessment summary for lumiliximab; Forecasts to 2018; PR1 peptide antigen (The Vaccine Company); Drug profile; Key historical events; Clinical trial data; PR1 vaccine elicits an immune response in 47% of leukemia patients; Datamonitor comments; The Vaccine Company could become a new player in the oncology market, but partnering with an experienced company would prove beneficial; Utilization of PR1 in three hematology indications as a maintenance therapy shows commercial potential; Datamonitor drug assessment summary for PR1 peptide antigen; Forecasts to 2018
CHAPTER 7 MOLECULAR-TARGETED THERAPIES ANALYSIS AND FORECASTS: Key findings; Overview of molecular-targeted therapies; ATC classification; L1X3 - Antineoplastic monoclonal antibodies; L1X9 - All other antineoplastics; Classification of pipeline products; Angiogenesis inhibitors; Single-target signal transduction inhibitors; Multi-targeted inhibitors; Cell cycle and apoptosis targeted inhibitors; Epigenetic modulators; Definition of current comparator therapy; Gleevec (Imatinib; Novartis) - comparator for pipeline molecular-targeted therapies; Late-phase pipeline analysis and forecasts; Pipeline summary; Late-phase pipeline of molecular-targeted therapies; Comparative forecasts; Alvocidib (flavopiridol; Sanofi-Aventis); Drug overview; Drug profile; Key historical events; Clinical trial data; Modified dosing needs to be employed as continuous infusion dosing schedules fail to demonstrate clinical activity; Alvocidib induces durable responses in relapsed chronic lymphocytic leukemia patients; Alvocidib in combination with chemotherapy is active in indolent B-cell lymphoproliferative disorders and mantle cell lymphoma; Datamonitor comments; Given alvocidib's checkered history, Sanofi-Aventis may face an uphill struggle communicating the drug's potential; Alvocidib may show more promise as part of a combination regimen; Presence in oncology field will aid commercialization of alvocidib; Datamonitor drug assessment summary for alvocidib; Forecasts to 2018; Avastin (bevacizumab; Genentech/Roche/Chugai); Drug overview; Drug profile; Key historical events; Clinical trial data; Phase III trial of Avastin with R-CHOP in first-line diffuse large B-cell lymphoma underway; Limited clinical trial data available to date; Datamonitor comments; Difficult to predict clinical benefit of Avastin in diffuse large B-cell lymphoma at this stage; Use of Avastin in diffuse large B-cell lymphoma could significantly increase cost of treatment; Genentech and Roche's marketing power will be essential in driving uptake of Avastin in non-Hodgkin's lymphoma; Datamonitor drug assessment summary for Avastin; Forecasts to 2018; Bosutinib (SKI-606; Wyeth, now part of Pfizer); Drug overview; Drug profile; Key historical events; Clinical trial data; Bosutinib Phase II results in Gleevec-resistant/intolerant chronic phase chronic myeloid leukemia; Bosutinib Phase II results in Gleevec-resistant/intolerant accelerated phase (AP) and blast crisis (BC) chronic myeloid leukemia and Ph+ acute lymphocytic leukemia; Datamonitor comments; The chronic myeloid leukemia market is comparatively well served by Gleevec, Sprycel and Tasigna; Like the others, bosutinib appears ineffective in patients harboring the T315I mutation - a key driver of resistance; Bosutinib trying to catch up with Sprycel and Tasigna in the race to replace Gleevec in the front-line setting; Datamonitor drug assessment summary for bosutinib; Forecasts to 2018; Enzastaurin (LY317615; Eli Lilly); Drug overview; Drug profile; Key historical events; Clinical trial data; Enzastaurin looking to make its mark in the B-cell lymphoma market; Enzastaurin holds promise as a maintenance therapy in mantle cell lymphoma; Datamonitor comments; Eli Lilly adopts a risky development/commercialization strategy for enzastaurin in diffuse large B-cell lymphoma; Termination of Phase III trial for enzastaurin in glioma may hamper its potential in other indications; Datamonitor drug assessment summary for enzastaurin; Forecasts to 2018; Genasense (oblimersen; Genta); Drug overview; Drug profile; Key historical events; Clinical trial data; FDA rejects Genasense for use in combination with chemotherapy in chronic lymphocytic leukemia, developmental status is unclear; Early-phase benefits of Genasense in acute myeloid leukemia require confirmation in Phase III clinical trial; Disappointing Phase III trial results in multiple myeloma means status of further development is unclear; Promise shown in combination with Rituxan in non-Hodgkin's lymphoma, but randomized trials have yet to be initiated; Datamonitor comments; Termination of agreement with Sanofi-Aventis is a major setback for Genta; Approval of Genasense is looking increasingly unlikely; HBP-347 (Hy BioPharma); Drug overview; Drug profile; Key historical events; Clinical trial data; Datamonitor comments; Hy BioPharma would benefit from partnering with a high profile, experienced company for commercialization of HBP-347; HBP-347's commercial potential is limited due to its formulation and small target population; Lestaurtinib (CEP-701; Cephalon); Drug overview; Drug profile; Key historical events; Clinical trial data; Lestaurtinib emerging as a promising agent for acute myeloid leukemia patients harboring Flt-3 activating mutations; Datamonitor comments; Sales of the potential first-in-class drug may be limited by the relatively small target population; Cephalon's acquisition of Trisenox will provide invaluable experience of the leukemia market; Datamonitor drug assessment summary for lestaurtinib; Forecasts to 2018; Midostaurin (Novartis); Drug overview; Drug profile; Key historical events; Clinical trial data; Amended midostaurin dose generates encouraging results in previously untreated acute myeloid leukemia; Datamonitor comments; Targeting the first-line acute myeloid leukemia setting seems to be the most reasonable strategy...; ...but the target population may not generate a high return on development costs; Novartis's experience in the leukemia market will be very beneficial; Datamonitor drug assessment summary for midostaurin; Forecasts to 2018; Omacetaxine mepesuccinate (ChemGenex Pharmaceuticals); Drug overview; Drug profile; Key historical events; Clinical trial data; Omacetaxine monotherapy is promising in Gleevec-resistant patients; Omacetaxine and Gleevec combination may be superior to Gleevec alone; Datamonitor comments; Strong competition in chronic myeloid leukemia means that targeting patients with T315I mutation could ensure notable uptake for omacetaxine; Omacetaxine would face strong competition in the wider chronic myeloid leukemia population as a second-line therapy; Datamonitor drug assessment summary for omacetaxine; Forecasts to 2018; Panobinostat (LBH589B; Novartis); Drug overview; Drug profile; Key historical events; Clinical trial data; Panobinostat showing promise in pretreated cutaneous T-cell lymphoma patients; Panobinostat shows synergy with doxorubicin in acute myeloid leukemia cell lines; Panobinostat's potential in multiple myeloma is less promising so far; Datamonitor comments; Novartis likely to evaluate panobinostat in other indications; Tanespimycin (Bristol-Myers Squibb); Drug overview; Drug profile; Key historical events; Clinical trial data; The combination of tanespimycin with Velcade shows manageable toxicity; Datamonitor comments; Synergistic activity of tanespimycin gives it strong potential as part of a combination regimen; Tanespimycin addresses a significant unmet need in multiple myeloma; Datamonitor drug assessment summary for tanespimycin; Forecasts to 2018; Torisel (temsirolimus; Wyeth, now part of Pfizer); Drug overview; Drug profile; Key historical events; Clinical trial data; Torisel shows further promise in mantle cell lymphoma; Torisel also making headway in other non-Hodgkin's lymphoma subtypes; Datamonitor comments; Torisel will have to face Velcade in the mantle cell lymphoma market; Wyeth's merger with Pfizer will strengthen its oncology presence; Datamonitor drug assessment summary for Torisel; Forecasts to 2018; Zarnestra (tipifarnib; Janssen/Johnson & Johnson); Drug overview; Drug profile; Key historical events; Clinical trial data; Zarnestra fails to increase overall survival in acute myeloid leukemia patients in a Phase III study; Zarnestra has been evaluated in a number of Phase II studies for acute myeloid leukemia; Importance of gene expression for Zarnestra realized in mantel cell lymphoma patients; Single-agent Zarnestra demonstrates antitumor activity in relapsed/refractory aggressive non-Hodgkin's lymphoma; Datamonitor comments; Mild toxicity is particularly significant for Zarnestra's main indication; Johnson & Johnson's experience will be invaluable to Zarnestra; Zarnestra's Phase III trial results raise more concerns regarding its future
CHAPTER 8 INNOVATIVE EARLY-STAGE APPROACHES: Key findings; Overview of early-stage innovative projects; Vascular endothelial growth factor; JAK; Aurora; The future of treatment in the hematological malignancies; Increased understanding of cancer evolution should result in a large range of potential drug targets; Longer term control of tumors with reduced toxicity is crucial; Improvements in diagnostics and prognostic analysis will enhance cost-effectiveness of treatment; Enhanced preventative strategies will ease the disease burden
BIBLIOGRAPHY
APPENDIX: Abbreviations; Methodology; Datamonitor forecast methodology; Epidemiology forecasts; Product forecasts; Contributing experts; About Datamonitor; About Datamonitor Healthcare; Datamonitor Healthcare's therapy area capabilities; About the Oncology analysis team; Disclaimer

Abstract

Introduction

There are 224 different pipeline products in clinical development for hematological malignancies. Twenty-three (10%) of these drugs are in late-phase studies and are forecast to achieve peak sales of $3.5 billion in 2018. Drug developers are keen to replicate the success of the two blockbusters: Biogen Idec/Genentech/Roche's Rituxan (rituximab) and Novartis's Gleevec (imatinib).

Scope

Epidemiology of the hematological malignancies split by disease subtype, covering the seven major markets as well as the top 5 rest of world markets
Overview of the current treatment options for leukemia, lymphoma, multiple myeloma and myelodysplastic syndromes with identification of unmet needs
Examination of the late-phase hematological malignancies pipeline, key company market strategies and opportunities for drug developers
Pipeline insight based on qualitative interviews with key opinion leaders in the field of hematological malignancies

Highlights

There are 13 molecular-targeted therapies, six immunotherapeutic agents and four cytotoxic agents in late-phase clinical development for hematological malignancies. Immunotherapeutic agents are forecast to achieve the highest class sales of $1.7 billion in the seven major markets by 2018.

Pipeline agents holding the greatest commercial potential include the immunoconjugated monoclonal antibodies Arzerra (ofatumumab; Genmab/GlaxoSmithKline), galiximab (Biogen Idec) and lumiliximab (Biogen Idec), as well as the cytotoxic agent pixantrone (Novartis).

Smaller, niche indications are increasingly attracting R&D interest as a result of the high unmet needs that persist in a number of hematological malignancy subtypes. At least 9 (39%) of the 23 late-phase pipeline agents are targeting patient sub-populations to potentially fill gaps in the market and facilitate launch.

Reasons to Purchase

Acquire a detailed appreciation and impartial perspective of the entire hematological malignancies developmental pipeline
Identify the key products in late-phase development based on sales forecasts to 2018 and Datamonitor's drug assessment methodology
Assess how the future treatment of many hematological malignancies will incorporate pipeline products

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Pipeline Insight: Hematological Malignancies Companies target niche indications to facilitate market entry

Table of Contents

Abstract