Stakeholder Opinions: Non-Hodgkin's Lymphoma - Is there room to emulate Rituxan's success?

Dec. 24, 2007 - PRLog -- Stakeholder Opinions: Non-Hodgkin's Lymphoma - Is there room to emulate Rituxan's success?
Introduction
Non-Hodgkin's lymphoma (NHL) is the most common hematological malignancy and is comprised of around 30 different disease subtypes. Each of these present with a distinct set histological, genetic and clinical characteristics. Treatment options in NHL include chemotherapy, targeted therapies, stem cell transplantation and radiotherapy.
Scope of this report
NHL background and epidemiology, including forecast incidence of the major subtypes in the seven major markets
Treatment of NHL by subtype and line of therapy, including major treatment controversies and areas of unmet need
Examination of pipeline activity including profiles of late-phase pipeline drugs
Stakeholder opinions based on qualitative interviews with opinion leaders from the US and Europe
Research and analysis highlights
Rituxan-based regimens constitute the mainstay of first-line treatment options in several NHL subtypes. Uptake of Rituxan in the maintenance setting for follicular lymphoma (FL) has allowed the drug to achieve further market penetration.
There is a lack of consensus over the treatment of relapsed and refractory disease in most NHL subtypes. Refractory patients are poorly served by currently available treatment options. Other unmet needs include detection of patients with aggressive lymphoma at high risk of relapse and an efficacious maintenance therapy for these patients.
The NHL late-phase pipeline is relatively active, with 10 Phase IIII drugs and 46 Phase II drugs. Monoclonal antibodies are among those agents that continue to demonstrate promising signs of clinical and commercial potential. However, Rituxan's status as market leader is unlikely to be challenged within the next 510 years.
Key reasons to read this report
Understand current epidemiological trends in non-Hodgkin's lymphoma and ongoing treatment options
Identify limitations of therapy currently available to non-Hodgkin's lymphoma patients and the potential of future therapy
Identify the key products in late-phase development for NHL. Consider, assess and react to opportunities and risks influencing their future potential
Table of Contents
ABOUT DATAMONITOR HEALTHCARE
About the Oncology pharmaceutical analysis team
Andrew Paramore - Oncology Lead Analyst & Head of Product Development
CHAPTER 1 EXECUTIVE SUMMARY
Scope of analysis
Datamonitor insight into the non-Hodgkin's lymphoma market
Related reports
Upcoming reports
CHAPTER 2 NON-HODGKIN'S LYMPHOMA: DISEASE BACKGROUND
Chapter summary
Disease overview and classification
Disease overview
Disease classification
NHL is classified under the WHO classification system
Immunophenotype differs between NHL subtypes
Several genetic abnormalities linked to NHL
NHL can follow an aggressive or indolent disease course
Diagnosis, staging and prognosis in NHL
Diagnosis of NHL
Ann Arbor staging system
Ann Arbor classification used for staging NHL but of limited prognostic use
Determining prognosis for NHL
International Prognostic Factor Index for aggressive NHL
International Prognostic Factor Index for FL
Molecular profiling in NHL
Epidemiology
Incidence of NHL in the seven major markets
NHL is the most commonly occurring hematological malignancy in the seven major markets
NHL incidence will total 122,000 in the seven major markets in 2007
Incidence of NHL by subtype in the seven major markets
Distribution of NHL subtypes varies considerably across the seven major markets
DLBCL and FL account for over 50% of new NHL diagnoses
Age distribution of NHL incidence rate
Mortality
NHL mortality will reach 47,000 in the seven major markets in 2007
Etiology
Immunodeficiency and immunosuppression as risk factors for NHL
Acquired immunodeficiency syndrome (AIDS)
Congenital immunodeficiency
Immunosuppressive drugs
Autoimmune disorders
Infections as risk factors for NHL
Human T-cell lymphotrophic virus (HTLV-1)
Epstein-Barr virus (EBV)
Helicobacter pylori
Hepatitis C
Occupational, environmental and lifestyle risk factors
Pesticides
Hair dyes
Lifestyle factors
CHAPTER 3 CURRENT TREATMENT OPTIONS FOR NON-HODGKIN'S LYMPHOMA
Chapter summary
Overview of NHL treatment options
Chemotherapy
Targeted therapies
Rituxan has made a large impact on NHL treatment outcomes
Radioimmunotherapies combine a monoclonal antibody and radioactive component
Drug developers aiming for widened indications for approved targeted therapies
Other drug classes
Combination regimens
Radiotherapy
Myeloablative therapy and stem cell transplantation
Treatment outcome measurements for NHL
Treatment of DLBCL
DLBCL overview
Induction therapy in DLBCL
R-CHOP established as standard of care for induction therapy in DLBCL
Treatment of refractory and relapsed DLBCL
Debate remains over second-line chemotherapy combinations and whether to add Rituxan in relapsed patients
Consolidation myeloablative therapy and ASCT recommended where possible in relapsed DLBCL
Lack of viable treatment of options in refractory patients
Improving treatment outcomes in DLBCL
Increasing the R-CHOP dose frequency may improve treatment outcomes in elderly patients
Rituxan use unlikely to extend to first-line maintenance therapy in DLBCL
Treatment of FL
FL overview
First-line therapy in FL
Initial treatment may be delayed for several years in some cases
Localized, non-bulky FL treated with radiotherapy
No established standard of care for patients with advanced FL
Addition of Rituxan to first-line chemotherapy improves treatment outcomes in FL
Radioimmunotherapy rarely used in first-line treatment of FL
Consolidation therapy in FL
Myeloablative therapy and ASCT superseded by Rituxan maintenance as a consolidation therapy in FL
Radioimmunotherapy may experience limited uptake as a consolidation therapy in FL despite promising data
Treatment of relapsed and refractory FL
Single-agent Rituxan or Rituxan-based regimens commonly used as second-line regimens in FL.
Limited use of radioimmunotherapy in relapsed or refractory FL despite promising evidence of efficacy
Benefit of myeloablative therapy and ASCT in treatment of relapsed or refractory FL uncertain
Rituxan maintenance in FL
Rituxan maintenance after first-line therapy and after second-line therapy improves PFS and overall survival in FL compared to observation
Unclear whether Rituxan maintenance adds clinical benefit after first-line Rituxan-containing regimen
Should Rituxan maintenance be used after induction therapy and after first relapse?
Optimal dosing schedule remains to be determined
Treatment of MALT lymphomas
Gastric MALT lymphoma
Localized gastric MALT lymphoma treated according to H. pylori status
Advanced gastric MALT lymphoma treated in a similar fashion to FL
Non-gastric MALT lymphoma
Treatment of MCL
First-line therapy in MCL
Rituxan increases efficacy of chemotherapy regimens used as induction therapy for MCL
Myeloablative therapy and ASCT used as consolidation therapy after induction therapy
Second-line therapy in MCL
Velcade is the first FDA-approved treatment option for relapsed MCL
Treatment of SLL
SLL treated in a similar fashion to indolent lymphomas

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