The global market for colorectal cancer (CRC) drugs is undergoing a fundamental shift due to wider generic competition in cytotoxics and increasing adoption of anti-EGFR products as first line therapies. What will be the impact on market leader Roche/Genetech's Avastin and how do leading clinicians view the changes?
The main drivers of change in the CRC market
- Avastin to come under pressure?
Roche/Genetech's all-conquering Avastin (bevacizumab) is expected to come under pressure in both primary and secondary settings. The principal driver of change in the primary setting is coming from more accurate diagnosis of disease sub types. Clinical studies with patients expressing the RAS wild-type phenotype suggest they may benefit more from BMS/ Merck KGaA's Erbitux (cetuximab) and Amgen's Vectibix (panitumumab). What will be the clinical and commercial impact of such a development on Avastin as the current first line therapy of choice?
- Competition will intensify in the refractory setting
Bayer's Stivarga (regorafenib) is currently the last option for patients with metastatic CRC but is dogged by adverse side effects in many patients. The product is vulnerable to Taiho Pharmaceuticals' nucleoside analogue TAS-102 and Dainippon Sumitomo Pharma's stem cell inhibitor BBI 608. While not yet launched, these compounds are expected to improve outcomes for refractory patients in terms of overall survival and tolerability.
- Cytoxics go completely generic
Despite the arrival of targeted therapies, cytotoxic therapies are still essential in the treatment of CRC, and will remain so for the foreseeable future. Lower cost treatment options with the full range of generic cytotoxics will be available when Roche's Xeloda (capecitabine) loses patent protection in late 2013. At one time the only treatment option, cytotoxics no longer drive the value of the CRC market.
A thorough briefing with unique insider clinical opinion
This new KOL Insight report Colorectal Cancer - EGFR inhibitors on the verge of growth provides everyone interested in this dynamic cancer sector with a complete understanding of the product developments which are shaping the operating environment and influencing commercial progress and clinical options. The report illuminates this changing environment with key "real world" insights from leading clinicians in the US and Europe on current and future products and how improving patient selection, drug combinations and new products could lead to radical changes for companies and patients alike.
The benefits of this report
- Learn in detail how improved patient selection will benefit EFGR inhibitors and why BMS/ Merck KGaA's Erbitux may experience greater gains than Amgen's Vectibix
- Assess the threats to Roche/Genetech's Avastin (bevacizumab) in first and second line therapies: how real are they?
- Appreciate how the treatment options will change for advanced patients: are clinicians in agreement about their benefits?
- Learn why some KOL's are questioning if Dainippon Sumitomo Pharma's TAS-102 offers real clinical advantage
- Compare clinical developments in new formulations of irinotecan: do they offer real advances?
- Evaluate the challenges and benefits of Imclone's ramucirumab: does it offer a step change in treatment of just another VEGF alternative?
- Assess the challenges for Regeneron/Bayers/Sanofi's Zaltrap (aflibercept) in finding a market position.
This report will allow you to:
- Understand and evaluate the important drivers in CRC treatments
- Know how the competitive landscape may change
- Understand clinical opinions of current and futures products
- Survey and appraise the late-stage product pipeline
- Appreciate how screening and better diagnostics are impacting incidence worldwide
Clinicians speak out!
The report provides critical clinical insights from leading clinicians in the field who answer key questions such as:
- What is your opinion of current therapies?
- What are the current unmet needs in CRC treatment?
- What is your opinion of pipeline therapies?
- What is the significance of recent and ongoing clinical trials and how will the results impact prescribing trends?
- What are the most significant future developments in the management of colorectal cancer?
Quotes from the report: experts share their insights
"You hear a lot that they [Erbitux and Vectibix] are interchangeable, but they are not the same. The data is very similar, but they've never been compared head-to-head, and there are cases where one works where the other doesn't, and vice versa. It's interesting, when Erbitux elicits a rash or panitumumab elicits a rash, and we discontinue the drug based on that, we can still use the other drug and you will not see the same rash or the same toxicity." Dr. Tanios Bekaii-Saab
"The weak points for bevacizumab are the absence of a predictive biomarker of efficacy, the cost, and in the locally advanced stages it does not work. I'm not expecting a lot more from bevacizumab in the coming years, as I think we have done everything that could be done." Dr. Jean-Yves Douillard
"Despite the fact that the incidence rate is going down, at least in the Unites States and much of Europe, we're still seeing a rise in the number of cases because the population is ageing – the 'baby boomer generation' is hitting their 60s, [the age] when we're going to start to see more colon cancer." Dr. Bert O'Neil
"The effect with Stivarga is very little, because it's not a new drug - it's just another way of angiogenesis inhibition. In principle we don't know what that really means, but at least some are benefitting, meaning the patients that want to have it should have it." Dr. Hans Joachim Schmoll
"Zaltrap's a drug that has a potential place, but its role until now is only in second line [treatment] of CRC, and there are certainly other competing drugs. We have to learn a bit better whether we should treat patients with bevacizumab in second line after progression in first line, or whether we should go for Zaltrap. That's not clear, but there are probably some patients where it has some place. The drug has in theory a broader mechanism of action than Avastin, but it also has a bit more toxicity." Dr. Eric Van Cutsem
"If the RAS mutation analysis comes back really significant and consistent across multiple studies, which is starting to appear as such, in the next year or two, there will be significantly more uptake of the anti-EGFR inhibitors in the first line world." Dr. Tanios Bekaii-Saab
- Dr Tanios Bekaii-Saab, MD, Associate Professor, College of Medicine, The Ohio State University, and Chair, Disease Specific Research Group for Gastrointestinal Oncology, OSU Comprehensive Cancer Center, Ohio, USA
- Dr Al B Benson III, MD, FACP, Professor in Medicine-Hematology/Oncology Northwestern University Feinberg School of Medicine, Chicago, USA
- Dr Thomas H Cartwright, MD, Medical Director, US Oncology Research and medical oncology and haematology specialist working in private practice at Ocala Oncology, Florida, USA.
- Dr Eric Van Cutsem, MD, PhD, Professor of Internal Medicine at the University of Leuven; Head of the Digestive Oncology Department at the University Hospital Gasthuisberg; and Board Member of Leuven Cancer Institute, Leuven, Belgium.
- Dr Jean-Yves Douillard, MD, PhD, Professor of Medical Oncology at the Integrated Centres of Oncology R. Gauducheau and University of Nantes Medical School, France.
- Dr Marwan G Fakih, MD, Professor and Director, Department of Medical Oncology and Therapeutics Research, City of Hope, California, USA.
- Dr Bert H. O'Neil, MD, Associate Professor Clinical Research, University of North Carolina Lineberger Comprehensive Cancer Care Center, North Carolina, USA.
- Dr Bassel el-Rayes, MD, Associate Professor, Emory University School of Medicine and Director, GI Oncology Translational Research Program, Winship Cancer Institute, Georgia, USA.
- Dr Hans-Joachim Schmoll,MD, Director, University Hospital for Internal Medicine IV, Oncology/Haematology, Martin-Luther University, Halle, Germany.
- Dr Alberto Sobrero, MD, PhD, Director of Medical Oncology Unit at S. Martino Hospital, Genova, Italy.
- Dr Michael Stahl, MD, PhD, Director of the Department of Medical Oncology, Haematology and Centre of Palliative Care, and Professor, Kliniken Essen-Mitte, the academic teaching hospital of the University of Duisburg-Essen,Germany.
- Dr Alan P Venook, MD, Professor, Department of Medicine (Hematology/Oncology), UCSF, San Francisco, USA.
- Requested Anonymous, Professor of Medicine in the Division of Medical Oncology at a large US academic medical center.
Table of Contents
Colorectal Cancer Disease Overview
Covering Epidemiology, Aetiology, Risk factors, Symptoms, Screening, Diagnosis, Prognosis,
Covering Surgery, Radiotherapy, Chemotherapy and Targeted therapies
Current systemic therapies
Cytotoxic therapies overview
- Eloxatin (oxaliplatin; Sanofi)
- Xeloda (capecitabine; Roche)
- Avastin (bevacizumab; Genentech/Roche/Chugai)
- Erbitux (cetuximab; Bristol-Myers Squibb/Merck KGaA)
- Vectibix (panitumumab; Amgen/Takeda)
- Zaltrap (ziv-aflibercept; Regeneron/Bayer Healthcare/Sanofi)
- Stivarga (regorafenib; Bayer Healthcare/Sanofi)
- TAS 102 (Taiho Pharmaceutical)
- Novel irinotecan formulations
- HA – irinotecan (hyaluronic acid irinotecan complex; Alchemia)
- NKTR-102 (etirinotecan pegol; Nektar Therapeutics)
- EZN-2208 (PEGylated irinotecan conjugate; Zhejiang Hisun Pharmaceuticals)
- Ramucirumab (ImClone Systems)
- BBI 608 (cancer stem cell inhibitor; Dainippon Sumitomo Pharma)
- OncoVAX (colorectal cancer vaccine; Vaccinogen)
- Imprime PGG (PGG glucan; Biothera)
- MGN 1703 (TLR-9 agonist; Mologen)
- BRAF and MEK inhibitors
- Tafinlar (dabrafenib; GlaxoSmithKline)
- Mekinist (trametinib; GlaxoSmithKline)
Current and future treatment algorithm
Future developments in Colorectal Cancer
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