Stakeholder Opinions: Hepatocellular Carcinoma - Opportune indication for novel therapies

Published by: Datamonitor

Published: Jun. 15, 2007 - 114 Pages

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 hepatocellular carcinoma market

CHAPTER 2 HCC OVERVIEW

Liver function

The damaged liver and its implications

Hepatocellular carcinoma

Epidemiology

Increasing incidence in the West

Poor prognosis but improving

Risk factors

Increasing hepatitis infection attributed to rising HCC incidence

Hepatitis B infection

Hepatitis C infection

Liver cirrhosis is a major risk factor for HCC

Aflatoxin exposure increases HCC risk

Diagnosis and screening

Diagnostic criteria

Diagnostic procedures

Biopsy

Ultrasound

Computerized tomography

Magnetic resonance imaging

Angiography

Alpha-fetoprotein

Staging

AJCC TNM staging system

Child-Pugh classification

Okuda staging system

The Cancer of the Liver Italian Program (CLIP)

BCLC classification

CHAPTER 3 CURRENT TREATMENT OPTIONS

Introduction

Treatment modalities

Surgical resection remains the mainstay of treatment for HCC

Liver transplantation is an option for patients with localized disease

Radiofrequency ablation may be as effective as surgery in selected patient cohorts

Opportunity for immunotherapy?

Use of percutaneous ethanol injection remains marginal

High complication rate of cryosurgery may limit its applicability

Transcatheter arterial chemoembolization (TACE) offers a survival improvement

Randomized study will be required to fully define role of hepatic arterial pumps

CHAPTER 4 CHEMOTHERAPY REGIMENS IN UNRESECTABLE HCC

Introduction

Compromised liver function may restrict use of chemotherapy

Single agents used in the management of HCC offer limited benefit

Doxorubicin

Doxil/Caelyx/Myocet (pegylated liposomal doxorubicin - Ortho Biotech/Schering-Plough/Cephalon/Sopherion)

Cisplatin

Gemzar (gemcitabine - Eli Lilly)

Xeloda (capecitabine - Roche)

Epirubicin

Tamoxifen

Intron A/Roferon A (interferon-alpha - Schering-Plough/Roche)

Combination regimens fail to demonstrate any significant efficacy advantage

Cisplatin and doxorubicin

Cisplatin, interferon-alpha, doxorubicin and 5-FU (PIAF)

Cisplatin, doxorubicin and Xeloda

Cisplatin and Gemzar

Cisplatin, epirubicin, UFT and leucovorin

Cisplatin, mitoxantrone and 5-FU

Gemzar and oxaliplatin

Liposomal doxorubicin plus Gemzar

Liposomal doxorubicin plus Xeloda or Gemzar

Interferon combinations

CHAPTER 5 UNMET NEEDS

Unmet needs

Curbing the increasing incidence of HCC

Lack of effective treatment

Poor clinical trial designs

Relatively modest R&D interest

CHAPTER 6 HCC PIPELINE ANALYSIS

Pipeline drugs for HCC

Pipeline drugs by phase

Pipeline drugs by drug class

Pipeline drugs by phase and drug class

Pipeline drugs in Phase III development

Talaporfin (LS11) - Light Sciences Oncology

Minimal toxicity is the key for talaporfin

Nexavar (sorafenib) - Onyx Pharmaceuticals /Bayer Schering

Phase III trial results indicate a 44% overall survival benefit associated with Nexavar

Phase II trial suggests Nexavar's potential to significantly improve median survival offered by doxorubicin

Ongoing Phase II combination trial will give better indication of Nexavar's worth

Nexavar does not have overlapping toxicities with doxorubicin

First-to-market status and collaboration will ensure Nexavar is the leading multi-kinase inhibitor in HCC

Thado (thalidomide) - TTY BioPharm

Phase II trial results do not support the use of thalidomide in HCC

Additional Phase II trial does not support use of thalidomide in HCC

Response in some patients may be due to etiology

Thalidomide unlikely to make its mark on the HCC market

AMT-2003 - Auron Healthcare

Dearth of data for AMT-2003

Key pipeline drugs in Phase II development

Avastin (bevacizumab) - Genentech/Roche/Chugai

Erbitux (cetuximab) - ImClone/Bristol-Myers Squibb/Merck Serono

Tarceva (erlotinib) - OSI Pharmaceuticals/Genentech/Roche/Chugai

Iressa (gefitinib) - AstraZeneca

Recentin (AZD2171/cediranib) - AstraZeneca

Velcade (bortezomib) - Millennium Pharmaceuticals/Ortho Biotech

Tykerb/Tycerb (lapatinib) - GlaxoSmithKline

Sutent (sunitinib) - Pfizer

APPENDIX

Contributing experts

UN Population Data

Bibliography

List of tables

List of figures

About Datamonitor

About Datamonitor Healthcare

About the Oncology analysis team

Disclaimer

List of Tables

Table 1: Incidence of HCC in the seven major markets, 2007-2016

Table 2: Prevalence of HBV in various areas worldwide

Table 3: AJCC TNM staging for liver tumors (including intrahepatic bile ducts)

Table 4: Child-Pugh classification

Table 5: Okuda staging system

Table 6: CLIP scoring for HCC

Table 7: Barcelona Clinic Liver Cancer classification

Table 8: Reported outcomes of surgical resection for HCC

Table 9: Improvement in five-year survival rates in HCC patients undergoing liver transplantation

Table 10: Comparison of RFA and surgical resection in terms of recurrence rates and overall survival

Table 11: Comparison of RFA in HCC patients with Child-Pugh class A and class B

Table 12: Arterial embolization or chemoembolization compared to systemic treatment for HCC

Table 13: Summary results of commonly used cytotoxic monotherapy in first-line unresectable HCC

Table 14: Summary results of commonly used cytotoxic combinations in first-line unresectable HCC

Table 15: Combining doxorubicin with cisplatin does not increase response rate

Table 16: Drugs in clinical development for HCC, 2007

Table 17: Ongoing clinical trials of Avastin in HCC

Table 18: Results of Phase II studies for unresectable HCC, 2007

Table 19: UN Population Data, 2002-2016

List of Figures

Figure 1: Liver anatomy

Figure 2: Incidence of HCC in the seven major markets, 2007-2016

Figure 3: Five-year survival rates for liver and intrahepatic bile duct cancer, 1975-1998

Figure 4: Association between HBV/HCV prevalence and HCC incidence

Figure 5: HCV disease progression leading to HCC

Figure 6: Treatment algorithm for HCC

Figure 7: Summary results of commonly used cytotoxic monotherapy in first-line unresectable HCC

Figure 8: Summary results of commonly used cytotoxic combinations in first-line unresectable HCC

Figure 9: Pipeline drugs for HCC by phase, 2007

Figure 10: Pipeline drugs for HCC by class, 2007

Figure 11: Pipeline drugs for HCC by phase and class, 2007

Figure 12: Results of Phase II studies for unresectable HCC, 2007

Abstract

Introduction

The close association with hepatitis means that hepatocellular carcinoma (HCC) is common in developing countries where hepatitis B and C infections are endemic. However, the increasing prevalence of hepatitis in the West means that incidence of HCC in the US and Europe is expected to increase significantly over the coming years.

Scope

Overview of hepatocellular carcinoma, including epidemiology, staging, prognosis and unmet needs

Review of current treatment modalities and physician opinion of existing and future treatment strategies

Evaluation of key drugs currently used in the treatment of hepatocellular carcinoma

Review of late-phase drugs in development for hepatocellular carcinoma including key opinion leaders' view on their potential

Highlights

Typically a disease of the developing countries, incidence of HCC is increasing in the West due to increasing cases of hepatitis infection, thus representing a revenue opportunity for pharmaceutical and biotechnology companies with targeted therapies.

HCC patients are poorly served by existing treatment options, with only a small proportion amenable to curative therapy such as surgical resection and liver transplantation. Prognosis is poor for unresectable patients, and there remains no standard drug therapy for advanced HCC.

Given the lack of standard of care, R&D interest in HCC is relatively high, with 37 compounds in clinical development. The majority consist of targeted therapies, with Bayer-Schering/Onyx's Nexavar, Genentech/Roche's Avastin and OSI/Genentech/Roche's Tarceva considered to have the highest clinical and commercial potential.

Reasons to Purchase

Evaluate opportunities and risks in the HCC market by analyzing the clinical and commercial potential of key pipeline drugs

Review critical factors that drive the HCC market to assess the potential of existing and pipeline drugs for the disease

Understand current and future competitive dynamics of HCC to determine the attractiveness of the market

Get Full Details About This Report >>

About MarketResearch.com
MarketResearch.com is an online aggregator selling over 160,000 market research reports, company profiles and country profiles from over 600 research firms. Our reports will provide you with the critical business and competitive intelligence you need for strategic planning and marketing research. Coverage includes the US, UK, Europe, Asia and global markets.