Pipeline Insight: Gastrointestinal Cancer Overview - Metastatic gastrointestinal cancers represent a significant commercial opportunity due to a lack of approved drugs
Datamonitor, March 2010, Pages: 279
Introduction
The five tumor types covered in this report are set to account for nearly 898,000 new patients in 2010. Collectively, the 18 drugs in Phase III development for the gastrointestinal cancers are forecast to achieve $5,404m in sales by 2019. Not all unmet needs will be fulfilled, therefore significant commercial opportunities exist for drug developers seeking to enter the market.
Scope
-Examination of the gastrointestinal cancers pipeline 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
-Segmentation and analysis of the current gastrointestinal cancers pipeline by developmental phase, drug class and company
-Insight and analysis of market potential including commercial opportunity, epidemiology and discussion of unmet needs
Highlights
There are 166 drugs in clinical development for the gastrointestinal cancers. Molecular targeted therapies are the predominant therapy class in the pipeline, accounting for 67%. Cytotoxic therapies account for 2% of the pipeline, while immunotherapies account for 15% and gene therapies for 16%.
Colorectal cancer is one of the 'big four' tumor types and has traditionally been a popular R&D target due to its high patient and commercial potential. Following the success of Avastin, drug developers are trying to emulate this, with all three late-phase pipeline products for colorectal cancer targeting angiogenesis.
Pancreatic cancer suffers from high levels of unmet need due to poor prognosis and a resistant nature, resulting in a high rate of Phase III failure. High unmet needs are likely to equate to high commercial reward, which has been noticed by drug developers, making pancreatic cancer the second most popular R&D target after colorectal cancer.
Reasons to Purchase
-Identify key drugs and companies within the gastrointestinal cancers pipeline based on sales forecasts to 2019 and Datamonitor drug assessment
-Characterize unmet need and poorly served patient groups within gastrointestinal cancer and assess the potential for pipeline products to fulfill them
-Assess the shifting gastrointestinal cancer market dynamic and how future treatment will incorporate pipeline products
Overview
Catalyst
Summary
Executive Summary
Strategic scoping and focus
Datamonitor insight into the gastrointestinal cancers market
Contributing experts
Related reports
Upcoming related reports
1. Pipeline Overview and Dynamics
Key findings
Pipeline overview
Pipeline summary
Molecular targeted therapies-either novel agents or marketed products undergoing indication expansion-form the bulk of the current late-phase gastrointestinal cancers pipeline
Pancreatic cancer has emerged as a popular R&D target due to a significant level of unmet need which could result in high commercial reward
Comparative forecasts
Key companies involved in the gastrointestinal cancers pipeline
Amgen
Eli Lilly
Roche
Key R&D company strategies
The metastatic gastrointestinal cancer population holds the most commercial potential, with the highest levels of unmet need in the second-line setting for some tumor types
The inclusion of molecular targeted therapies into treatment of gastrointestinal cancers appears to be the way forward
2. R&D Approach
Key findings
Clinical trial design in gastrointestinal cancers
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 gastrointestinal cancers
Most oncology clinical trials designate multiple endpoints
Survival
Quality of life
Tumor response rates
Toxicity
Time to tumor progression
3. Colorectal Cancer
Key findings
Disease overview
Definition
Colorectal cancer is the third most common tumor type and cause of cancer-related death in both men and women
Patient segmentation
The American Joint Committee on Cancer TNM classification system has replaced the older Dukes staging system
Epidemiology
Seven major markets
Rest of the world
Current treatment options
Current comparator therapy
Eloxatin (oxaliplatin; Sanofi-Aventis)
Unmet need in colorectal cancer
Better screening approaches needed to decrease mortality rates
More effective therapies are needed in both early-stage and advanced disease
Biomarkers and the selection of patients may help improve outcomes
Target product profile versus current level of attainment
Pipeline analysis and forecasts
Pipeline summary
Comparative forecasts
Aflibercept (VEGF-Trap; Regeneron/Sanofi-Aventis)
Drug overview
Drug profile
Key historical events
Clinical trial data
Phase II results show aflibercept to confer better antitumor activity in patients previously treated with Avastin
SWOT analysis
Datamonitor drug assessment scorecard for aflibercept
Clinical and commercial attractiveness
Aflibercept's primary development in second-line colorectal cancer means direct competition with Avastin in the first-line setting can be avoided...
...although several factors may hamper aflibercept's uptake in the second-line setting
Aflibercept still needs to differentiate itself from other angiogenesis inhibitors in development for colorectal cancer
Presence in colorectal cancer will aid commercialization of aflibercept
Satisfaction of unmet needs
Forecasts to 2019
Brivanib (BMS-582664; Bristol-Myers Squibb)
Drug overview
Drug profile
Key historical events
Clinical trial data
Phase I/II results show brivanib to confer better clinical benefit in patients with wild-type KRAS tumors
SWOT analysis
Datamonitor drug assessment scorecard for brivanib
Clinical and commercial attractiveness
Better clinical benefit in wild-type KRAS tumors could boost brivanib's apparent efficacy in second-line colorectal cancer
Economic evaluation is an encouraging inclusion as part of the Phase III trial endpoints
Clinical efficacy of brivanib could be enhanced if Phase III development was alongside chemotherapy...
...as could eventual uptake in the second-line colorectal cancer setting
Bristol-Myers Squibb offers ideal credentials to ensure brivanib's potential in colorectal cancer is maximized
Satisfaction of unmet needs
Forecasts to 2019
Recentin (cediranib; AstraZeneca)
Drug overview
Drug profile
Key historical events
Clinical trial data
Top-line results from the Phase III HORIZON III study failed to show any benefit of Recentin over Avastin in combination with first-line chemotherapy
Phase II results show Avastin to confer greater progression-free survival alongside standard second-line chemotherapy than Recentin
SWOT analysis
Datamonitor drug assessment scorecard for Recentin
Clinical and commercial attractiveness
Phase III HORIZON III results mean Recentin will find it difficult to compete in the first-line setting...
...while the ongoing Phase III HORIZON II study is high-risk
Avastin's mode of action and formulation may be more effective than Recentin's
Targeting the Japanese market?
AstraZeneca's strength in the oncology market will be key in Recentin's success
Satisfaction of unmet needs
Forecasts to 2019
4. Esophageal Cancer
Key findings
Disease overview
Definition
Esophageal cancer is a major source of cancer-related death
Patient segmentation
Esophageal cancer has been pathologically staged since 2002
Epidemiology
Seven major markets
Rest of the world
Current treatment options
Current comparator therapy
Xeloda (capecitabine; Roche)
Unmet need in esophageal cancer
Earlier diagnosis could improve prognosis of esophageal cancer
New and more effective systemic therapies for advanced disease are required
More effective neoadjuvant and/or adjuvant therapy to reduce relapse rates
More large-scale, randomized clinical trials are necessary to define optimal treatment strategies
Target product profile versus current level of attainment
Pipeline analysis and forecasts
Pipeline summary
Comparative forecasts
Tykerb (lapatinib; GlaxoSmithKline)
Drug overview
Drug profile
Key historical events
Clinical trial data
One Phase II trial has shown minimal activity in second-line metastatic esophageal cancer, and two Phase II studies have been terminated to date
SWOT analysis
Datamonitor drug assessment scorecard for Tykerb
Clinical and commercial attractiveness
Minimal clinical data have been reported for Tykerb in esophageal cancer, making it difficult to judge its clinical attractiveness
EGFR inhibition is a popular strategy for gastrointestinal tumors, but experience in esophageal cancer has been dubious so far
HER-2 inhibition is a rarer strategy, although has proven successful in gastric cancer
Concerns exist over Tykerb's association with hepatotoxicity
Tykerb's oral formulation may prove problematic...
...however, it could become the first approved therapy for esophageal cancer
Satisfaction of unmet needs
Forecasts to 2019
5. Gastric Cancer
Key findings
Disease overview
Definition
Gastric cancer is the second most common tumor type on a global scale
Patient segmentation
A more detailed Japanese staging system exists for gastric cancer, but is not used in the US or Europe
Epidemiology
Seven major markets
Rest of the world
Current treatment options
Current comparator therapy
Taxotere (docetaxel; Sanofi-Aventis)
Unmet need in gastric cancer
Lack of effective systemic therapy
Poorly defined standard treatment regimens
Poor control of distant metastases
Complete lack of second-line options
Target product profile versus current level of attainment
Pipeline analysis and forecasts
Pipeline summary
Comparative forecasts
Herceptin (trastuzumab; Genentech/Roche/Chugai)
Drug overview
Drug profile
Key historical events
Clinical trial data
Phase III ToGA study shows the addition of Herceptin to first-line chemotherapy to result in a 2.7 month survival benefit in HER-2-positive metastatic gastric cancer
SWOT analysis
Datamonitor drug assessment scorecard for Herceptin
Clinical and commercial attractiveness
Herceptin is the first molecular targeted therapy to gain approval for gastric cancer
Targeting HER-2-positive patients specifically is in line with the trend for more personalized therapy...
...however, restricts Herceptin's commercial potential in gastric cancer
Tykerb could pose a competitive threat to Herceptin
Concerns exist over Herceptin's association with cardiotoxicity
Roche's leading position in the oncology market will almost certainly lead to success
Satisfaction of unmet needs
Forecasts to 2019
Avastin (bevacizumab; Genentech/Roche/Chugai)
Drug overview
Drug profile
Key historical events
Clinical trial data
The Phase III AVAGAST study failed to meet its primary endpoint of improving overall survival in the first-line metastatic gastric cancer setting
Several Phase II studies have shown encouraging survival results associated with Avastin, however, the risk of gastrointestinal perforations and bleeding remains a major concern
SWOT analysis
Datamonitor drug assessment scorecard for Avastin
Clinical and commercial attractiveness
Failure of the Phase III AVAGAST study to meet its primary endpoints in first-line metastatic gastric cancer is a setback...
...although Avastin could still have a role in resectable gastric cancer
Roche's leading position in the oncology market will almost certainly result in success
Increasingly cost-conservative healthcare systems could restrict potential uptake of Avastin
Satisfaction of unmet needs
Forecasts to 2019
Erbitux (cetuximab; Eli Lilly/Bristol-Myers Squibb/Merck KGaA)
Drug overview
Drug profile
Key historical events
Clinical trial data
Several Phase II studies have shown encouraging survival results associated with Erbitux, with a potential tumor response correlation linked to incidence of acneiform rash
SWOT analysis
Datamonitor drug assessment scorecard for Erbitux
Clinical and commercial attractiveness
Phase II data show a comparable response rate to the current first-line standard, but the Phase III EXPAND trial will need to demonstrate superior overall survival
Erbitux's cost may hinder its uptake in certain markets...
...although if use is targeted to specific patient subtypes, then the issue of cost may be overcome
Satisfaction of unmet needs
Forecasts to 2019
Afinitor (everolimus; Novartis)
Drug overview
Drug profile
Key historical events
Clinical trial data
Phase II results showed 0% overall response rate, but a very encouraging median overall survival of 10.1 months in heavily pretreated metastatic gastric cancer patients
SWOT analysis
Datamonitor drug assessment scorecard for Afinitor
Clinical and commercial attractiveness
If Phase III trial replicates Phase II survival, then Afinitor could become the standard of care in second-line metastatic gastric cancer
A relatively high rate of treatment discontinuation due to adverse events was seen in the Phase II study
Afinitor is set to be the first agent to reach the market for second-line metastatic gastric cancer
Afinitor shows applicability for use across the wider gastric cancer population
Design of the Phase III GRANITE-1 study may unnecessarily come under fire
Novartis's experience in the oncology market will prove crucial in ensuring Afinitor's success in gastric cancer
Satisfaction of unmet needs
Forecasts to 2019
Tykerb (lapatinib; GlaxoSmithKline)
Drug overview
Drug profile
Key historical events
Clinical trial data
Phase II results have shown minimal activity in first-line metastatic gastric cancer and failure to meet its primary endpoint of overall response rate
SWOT analysis
Datamonitor drug assessment scorecard for Tykerb
Clinical and commercial attractiveness
Minimal clinical data have been reported for Tykerb in gastric cancer, making it difficult to judge its clinical attractiveness
Dual inhibition of EGFR and HER-2 is a relatively new strategy in treatment of gastric cancer
Concerns exist over Tykerb's association with hepatotoxicity
Tykerb could provide strong competition to Herceptin in HER-2-positive gastric cancer
Satisfaction of unmet needs
Forecasts to 2019
Ramucirumab (IMC-1121B; Eli Lilly)
Drug overview
Drug profile
Key historical events
Clinical trial data
Only Phase I results in solid tumors have been made available to date
SWOT analysis
Datamonitor drug assessment scorecard for ramucirumab
Clinical and commercial attractiveness
A lack of clinical trial data makes it difficult to judge ramucirumab's potential in gastric cancer
Ramucirumab will lose out to Afinitor in terms of first-to-market advantage for second-line gastric cancer
The failure of Avastin in the first-line setting may work in ramucirumab's favor
Eli Lilly's experience in the oncology market will prove crucial in ensuring ramucirumab's success in gastric cancer
Satisfaction of unmet needs
Forecasts to 2019
6. Hepatocellular Carcinoma
Key findings
Disease overview
Definition
Hepatitis is a known risk factor for hepatocellular carcinoma
Patient segmentation
Several staging systems exist for hepatocellular carcinoma
Epidemiology
Seven major markets
Rest of the world
Current treatment options
Current comparator therapy
Nexavar (sorafenib; Onyx Pharmaceuticals/Bayer Schering)
Unmet need in hepatocellular carcinoma
Better systemic therapy is required in all lines of treatment
Clinical trials are currently poorly designed
Target product profile versus current level of attainment
Pipeline analysis and forecasts
Pipeline summary
Comparative forecasts
Brivanib (BMS-582664; Bristol-Myers Squibb)
Drug overview
Drug profile
Key historical events
Clinical trial data
Phase II results show brivanib to confer activity in both the first- and second-line treatment settings for advanced hepatocellular carcinoma
SWOT analysis
Datamonitor drug assessment scorecard for brivanib
Clinical and commercial attractiveness
Competing with Nexavar in the first-line setting may be difficult unless brivanib demonstrates significant superiority...
...therefore it is commercially astute of Bristol-Myers Squibb to also target alternative treatment settings
Development as an adjuvant to first-line trans-arterial chemo-embolization could also enhance uptake of brivanib
Bristol-Myers Squibb is well placed to ensure brivanib's potential in hepatocellular carcinoma is maximized
Satisfaction of unmet needs
Forecasts to 2019
Tarceva (erlotinib; OSI Pharmaceuticals/Genentech/Roche)
Drug overview
Drug profile
Key historical events
Clinical trial data
Phase II results show Tarceva to confer antitumor activity in advanced hepatocellular carcinoma both as a monotherapy, in combination with chemotherapy and in combination with other molecular targeted therapies
SWOT analysis
Datamonitor drug assessment scorecard for Tarceva
Clinical and commercial attractiveness
Tarceva in combination with angiogenesis inhibition has resulted in very encouraging survival results...
...therefore Phase III development in combination with Nexavar should in theory result in enhanced efficacy
The overall cost of a combination of Nexavar and Tarceva could be prohibitively expensive in some markets
Roche's leading position in the oncology market will almost certainly result in success
Satisfaction of unmet needs
Forecasts to 2019
Afinitor (everolimus; Novartis)
Drug overview
Drug profile
Key historical events
Clinical trial data
Phase I data suggest that Afinitor is capable of stabilizing progression of hepatocellular carcinoma
SWOT analysis
Datamonitor drug assessment scorecard for Afinitor
Clinical and commercial attractiveness
Afinitor's potential is difficult to judge in hepatocellular carcinoma owing to lack of reported data
Afinitor is likely to lose out on first-to-market advantage in second-line gastric cancer...
...although its mechanism of action could differentiate it from the competition
Novartis's experience in the oncology market will prove crucial to ensuring Afinitor's success in hepatocellular carcinoma
Satisfaction of unmet needs
Forecasts to 2019
Linifanib (ABT-869; Abbott)
Drug overview
Drug profile
Key historical events
Clinical trial data
Phase II results show linifanib to confer clinical benefit in both the first- and second-line treatment settings for advanced hepatocellular carcinoma
SWOT analysis
Datamonitor drug assessment scorecard for linifanib
Clinical and commercial attractiveness
By excluding second-line patients from the ongoing Phase III trial, linifanib could show equivalent or superior survival results to Nexavar
Other pipeline agents pose a significant threat to linifanib...
...therefore Abbott could also target alternative treatment settings or patient subgroups within hepatocellular carcinoma to differentiate linifanib
To maximize linifanib's commercial potential, Abbott would be astute in taking on board a marketing partner
Satisfaction of unmet needs
Forecasts to 2019
ThermoDox (liposomal doxorubicin; Celsion/Yakult Honsha)
Drug overview
Drug profile
Key historical events
Clinical trial data
Phase I results show a favorable overall response rate and low local recurrence rate for ThermoDox and radiofrequency ablation in hepatocellular carcinoma and cancer metastatic to the liver
SWOT analysis
Datamonitor drug assessment scorecard for ThermoDox
Clinical and commercial attractiveness
Phase I results are insufficient to judge ThermoDox's commercial potential
Most hepatocellular carcinoma patients present with disease that is too advanced for radiofrequency ablation
In order to optimize ThermoDox's commercial potential, Celsion should seek a partner experienced in the oncology market
Satisfaction of unmet needs
Forecasts to 2019
Sutent (sunitinib; Pfizer)
Drug overview
Drug profile
Key historical events
Clinical trial data
Phase II studies show evidence of some antitumor activity, although toxicity and fatalities associated with Sutent are a concern
SWOT analysis
Datamonitor drug assessment scorecard for Sutent
Clinical and commercial attractiveness
Sutent will have to show significantly superior survival benefits in order to effectively compete with Nexavar in the advanced hepatocellular carcinoma population and overcome negative Phase II results
Other late-phase pipeline agents also pose a competitive threat to Sutent
Altering Sutent's target patient population in hepatocellular carcinoma could be the key to commercial success
Pfizer's growing position in the oncology market will assist in Sutent's potential success
Satisfaction of unmet needs
Forecasts to 2019
7. Pancreatic Cancer
Key findings
Disease overview
Definition
Pancreatic cancer represents a major health issue in the developed world
Patient segmentation
The TNM staging system does not take resectability of a tumor into account, therefore an alternative clinical staging system is often used
Epidemiology
Seven major markets
Rest of the world
Current treatment options
Current comparator therapy
Gemzar (gemcitabine; Eli Lilly)
Unmet need in pancreatic cancer
Pancreatic cancer is associated with exceptionally poor survival rates across all stages of disease
Earlier rates of diagnosis are desperately needed in order to boost survival
A lack of effective systemic therapies exists, therefore a higher level of R&D interest is needed
An effective neoadjuvant or adjuvant regimen is required to prevent high rates of recurrence after surgery for early-stage disease
More options for the few patients who receive second-line treatment are needed
Target product profile versus current level of attainment
Pipeline analysis and forecasts
Pipeline summary
Comparative forecasts
Abraxane (albumin-bound paclitaxel; Abraxis Bioscience/Taiho)
Drug overview
Drug profile
Key historical events
Clinical trial data
Phase II results show Abraxane monotherapy to confer an encouraging median overall survival in the second-line metastatic pancreatic cancer setting
Phase I/II results show the addition of Abraxane to first-line Gemzar to boost median overall survival by several months over Gemzar monotherapy
SWOT analysis
Datamonitor drug assessment scorecard for Abraxane
Clinical and commercial attractiveness
A combination of encouraging clinical data and key opinion leader enthusiasm mean Abraxane is currently the most promising late-phase pipeline candidate for pancreatic cancer
Identification of a potential biomarker could further increase apparent efficacy of Abraxane in pancreatic cancer
The widespread availability of generic standard paclitaxel may hamper uptake of Abraxane...
...however, Abraxane's efficacy in pancreatic cancer arises in part due to its albumin-bound formulation
The taxanes are not typically used to treat pancreatic cancer...
Abraxis Bioscience's experience in breast cancer will prove useful if Abraxane is approved for pancreatic cancer
Satisfaction of unmet needs
Forecasts to 2019
TNFerade (golnerminogene; GenVec)
Drug overview
Drug profile
Key historical events
Clinical trial data
Interim data from the PACT study show a 25% reduction in the risk of death when TNFerade is added to standard first-line therapy
SWOT analysis
Datamonitor drug assessment scorecard for TNFerade
Clinical and commercial attractiveness
Unmet needs in pancreatic cancer are so high, that if final PACT results are positive, TNFerade will be enthusiastically received
No gene therapies are approved for cancer in the seven major markets
Intratumoral administration into a pancreatic tumor may prove problematic
GenVec may struggle to achieve commercial success for TNFerade without a more experienced oncology player
Satisfaction of unmet needs
Forecasts to 2019
Masitinib (AB-1010; AB Science)
Drug overview
Drug profile
Key historical events
Clinical trial data
Phase II trial shows a first-line combination of Gemzar and masitinib to confer similar efficacy to Gemzar monotherapy and other Gemzar-based combinations
SWOT analysis
Datamonitor drug assessment scorecard for masitinib
Clinical and commercial attractiveness
If Phase II results can be replicated in the ongoing Phase III study, then approval will be likely
Masitinib should in theory confer greater efficacy alongside Gemzar than Tarceva due to inhibition of multiple pathways
AB Science will need to price masitinib competitively in order to enhance its uptake
In order to optimize masitinib's commercial potential, AB Science should seek a partner experienced in the human oncology market
Satisfaction of unmet needs
Forecasts to 2019
Tertomotide (GV-1001; Pharmexa/Kael-GemVax)
Drug overview
Drug profile
Key historical events
Clinical trial data
A Phase III trial investigating GV-1001 followed by sequential Gemzar in advanced pancreatic cancer patients has already failed
Phase I/II trial data indicate an immune response is correlated with prolonged survival
SWOT analysis
Datamonitor drug assessment scorecard for GV-1001
Clinical and commercial attractiveness
Replication of Phase I/II median survival in the ongoing Phase III studies will almost surely guarantee approval
PrimoVax Phase III failure highlights the difficulties of sequencing chemotherapy with therapeutic cancer vaccines
GV-1001 may struggle to achieve optimal market penetration without a more experienced oncology player
A lack of precedent regarding approval of therapeutic cancer vaccines exists
Satisfaction of unmet needs
Forecasts to 2019
Bibliography
Journals
Websites
Datamonitor reports
Other
APPENDIX
Methodology
Epidemiology forecasts
Product forecasts
Datamonitor drug assessment scorecard
About Datamonitor
About Datamonitor Healthcare
About the Disease analysis team
Datamonitor consulting
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