Pipeline: Renal Cell Cancer

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Pipeline: Renal Cell Cancer
Published on January 2013

Report Summary

Introduction

Seven targeted therapies are available for the treatment of RCC but there is still considerable pipeline activity. Currently approved
targeted therapies have been unable to produce durable responses in RCC patients and only delay progression. As a consequence,
effective treatment options capable of sustaining responses in RCC are still required.

Scope

' Analysis of late-stage pipeline drugs including a comparison of clinical and commercial attributes to determine competitiveness in
the marketplace.
' Identifying key trends, clinical trial design and innovative early-stage projects.
' Predictions on how future treatment may emerge.
' Review of candidates in development for renal cell cancer across the US, Japan, and five major EU markets.
' Insight from several key opinion leaders

Highlights

Datamonitor has identified 63 drugs currently in development for RCC, of which 38 are targeted therapies, 15 are immunotherapies,
five are cytotoxic therapies, four are cancer vaccines, and one is a gene therapy.AGS-003, IMA901 and BMS-936558 currently in
Phase III development for RCC are just some of the drugs discussed within this Datamonitor Healthcare report.

Purchase Reasons

' What key trends are emerging for the future treatment of renal cell cancer'
' What are the most popular targets for early-stage pipeline drugs'
' What are the strengths, weaknesses, opportunities and threats of phase 3 drugs'
' How do phase 3 drugs compare to the current standard of care'

Table of Content

' Overview

EXECUTIVE SUMMARY
' Datamonitor key findings

Clinical Pipeline Overview

Pipeline: Renal Cell Cancer (From Slideshare) Page 1/8


' Datamonitor has identified 63 drugs in development for renal cell cancer - A large percentage of drugs in development are in
Phase II clinical trials
- Targeted therapies dominate the late-stage pipeline
- The renal cell cancer pipeline has grown over the last 5 years
- The clinical potential of a cancer vaccine in RCC continues to be an incentive for drug developers

' Late-stage development compounds recently discontinued - Rencarex (girentuximab, Wilex/Prometheus/Dr Esteve)No
improvement in disease-free survival prompts Phase III termination
- Oncophage (vitespen; Agenus)
- TroVax (MVA-h5T4/Oxford BioMedica)

Target Product Profile
' Renal cell cancer - Sutent (sunitinib; Pfizer)
- Clinical trial data for Sutent
- Unmet needs in renal cell cancer

Clinical Trial Design in Renal Cell Cancer
' Clinical trial design
- Patient selection
- Clinical trial duration
- Clinical trial endpoints

' Future developments in clinical trial design
- Immunological monitoring of cancer vaccines in RCC
- Using molecular endpoints in early-stage clinical trials

Innovative Early-Stage Approaches
' Mesenchymal transitional factor (MET)
' PI3K/Akt pathway - Multiple targeting of the PI3K and mTOR

THE FUTURE OF TREATMENT IN RENAL CELL CANCER
' Improved treatment options in early-stage disease
' The identification of biomarkers will enhance the treatment of RCC
' Efforts continue to develop a cancer vaccine in RCC

BIBLIOGRAPHY
' Journal papers
' Websites

APPENDIX
' Market definition
' Contributing experts

Late-Stage Product Profiles



- Datamonitor's assessment summary

' AGS-003 (Argos Therapeutics/Kyowa Hakko Kirin)
- Drug overview
- Drug profile
- Development overview
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness

' Anyara (naptumomab estafenatox; Active Biotech)
- Drug overview
- Drug profile
- SWOT analysis

' BMS-936558 (Bristol-Myers Squibb/Ono Pharmaceutical)
- Drug overview
- Drug profile
- SWOT analysis

' Dovitinib (TKI258; Novartis)
- Drug overview
- Drug profile
- SWOT analysis

' IMA901 (Immatics Biotechnologies)
- Drug overview
- Drug profile
- SWOT analysis

' Tivozanib (Astellas Pharma/AVEO Pharmaceuticals/Kyowa Hakko Kirin)
- Drug overview
- Drug profile
- SWOT analysis




Bibliography
' AGS-003
- Journal papers
- Websites

' Anyara
- Journal papers
- Websites

' BMS-936558
- Journal papers
- Websites

' Dovitinib
- Journal papers
- Websites

' IMA901
- Journal papers
- Websites

' Tivozanib
- Journal papers
- Websites

TABLES
' Table: Phase III pipeline products in development for renal cell cancer, January 2013
' Table: Recently discontinued drugs in renal cell cancer, 2013
' Table: Sutent ' drug profile, 2013
' Table: Ability of Sutent (sunitinib; Pfizer) to meet unmet needs in RCC, 2013
' Table: Phase III trial design for Inlyta, 2013
' Table: Clinical endpoints that led to the approval of current treatments for RCC
' Table: Top five early-stage renal cell cancer drug targets, 2013
' Table: Phase III trials for early-stage renal cell cancer patients, January 2013
' Table: Summary of therapeutic classes in RCC by ATC code, 2012
' Table: Phase III pipeline products in development for renal cell cancer, December 2012
' Table: AGS-003 ' drug profile, 2013
' Table: Clinical development of AGS-003 in RCC, 2013
' Table: Ability of AGS-003 to meet unmet needs in RCC, 2013
' Table: Anyara ' drug profile, 2013
' Table: Clinical development of Anyara in RCC, 2013
' Table: BMS-936558 ' drug profile, 2013
' Table: Clinical development of BMS-936558 in RCC, 2013
' Table: Dovitinib ' drug profile, 2013



' Table: Clinical development of dovitinib in RCC, 2013
' Table: IMA901 ' drug profile, 2013
' Table: Clinical development of IMA901 in RCC, 2010
' Table: Tivozanib ' drug profile, 2013
' Table: Clinical development of Tivozanib in RCC, 2013
' Table: Ability of tivozanib to meet unmet needs in RCC, 2013

FIGURES
' Figure: Renal cell cancer clinical pipeline, by development stage, 2012
' Figure: Renal cell cancer clinical pipeline, by development stage, 2013
' Figure: Pipeline RCC therapies, by therapeutic class and phase, 2012
' Figure: Pipeline RCC therapies, by therapeutic class and phase, 2013
' Figure: RCC pipeline, by class, 2007 and 2012
' Figure: RCC pipeline, by class, 2007 and 2013
' Figure: Phase III pivotal trial data examining Sutent compared to interferon alpha in first-line treatment-naïve metastatic renal cell
cancer
' Figure: Early-stage renal cell cancer pipeline, by drug class, 2012
' Figure: Early-stage renal cell cancer pipeline, by drug class, 2013
' Figure: Datamonitor's drug assessment summary of key pipeline drugs for RCC, 2013
' Figure: Phase II results for first-line AGS-003 in advanced RCC
' Figure: AGS-003's SWOT analysis for RCC, 2013
' Figure: Datamonitor's drug assessment summary for AGS-003 in RCC, 2013
' Figure: Datamonitor's drug assessment summary for AGS-003 in RCC, 2013
' Figure: Anyara's SWOT analysis for RCC, 2013
' Figure: Datamonitor's drug assessment summary for Anyara in RCC, 2013
' Figure: Datamonitor's drug assessment summary for Anyara in RCC, 2013
' Figure: Phase I results for BMS-936558 in advanced RCC
' Figure: BMS-936558's SWOT analysis for RCC, 2013
' Figure: Datamonitor's drug assessment summary for BMS-936558 in RCC, 2013
' Figure: Datamonitor's drug assessment summary for BMS-936558 in RCC, 2013
' Figure: Phase II results for second-line and third-line dovitinib in metastatic RCC
' Figure: Dovitinib's SWOT analysis for RCC, 2013
' Figure: Datamonitor's drug assessment summary for dovitinib in RCC, 2013
' Figure: Datamonitor's drug assessment summary for dovitinib in RCC, 2013
' Figure: Phase II results for second-line IMA901 in advanced HLA-A*02 RCC
' Figure: IMA901's SWOT analysis for RCC, 2013
' Figure: Datamonitor's drug assessment summary for IMA901 in RCC, 2013
' Figure: Datamonitor's drug assessment summary for IMA901 in RCC, 2013
' Figure: Phase III results for first-line tivozanib for advanced RCC
' Figure: Tivozanib's SWOT analysis for RCC, 2013
' Figure: Datamonitor's drug assessment summary for tivozanib in RCC, 2013
' Figure: Datamonitor's drug assessment summary for tivozanib in RCC, 2013

Companies Mentioned



Active Biotech AB, Anheuser-Busch InBev SA/NV, Aviva Plc, Devoteam SA, GlaxoSmithKline Plc, Hutchison 3G UK Limited, Kewill
Ltd, Novartis AG, Sanofi


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