Abstract
Introduction
Drug companies' cancer pipelines are bulging, and hundreds of new drugs are in development-the modern equivalent of a gold rush. Remarkable successes have been recorded with targeted oncology, but the treatment of more than 200 types of cancer remains a daunting task. Today' s three principal modalities of cancer treatment-surgery, radiotherapy, drug treatment-have begun to give way to new targeted techniques. Genentech/Roche/Chugai' s Herceptin and ten other blockbuster “targeted” therapies have shown that drugs designed to interact with specifi c molecular targets can hit cancer where it hurts. However, targeted therapies are no panacea; to continue advancing cancer treatment, investigators must continue to improve their understanding of specifi c drug targets and continue to explore gene regulation and protein networks, to which targeted oncology therapies owe their existence.
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- In 2007, there were 11 highly successful targeted cancer blockbusters. Which drugs were they, and which blockbusters also carried a strong warning label: namely, the dreaded “black box” authorized by the FDA?
- Amgen recently suffered several setbacks, including unfavorable trial results from a Phase III trial of Vectibix in fi rst-line, metastatic colorectal cancer. But Amgen still has upward of 60 ongoing development programs. Why is this company still in need of a more vibrant pipeline?
- Bristol-Myers Squibb has a solid presence in targeted oncology drugs with its blockbuster drug Erbitux. Which other drug in Bristol-Myers Squibb' s portfolio represents a signifi cant achievement in the rational design of drugs to overcome drug resistance in cancer?
- With Avastin, Herceptin, and Rituxan/MabThera, Genentech and Roche are on track to rack up more than $11 billion in combined worldwide revenues in 2007. Competition is on the way, however. Which companies have drugs in Phase III trials for non-small-cell lung cancer? What are Genentech/Roche' s strategies for expanding their prolifi c oncology franchise?
- For the last few years, ImClone has been sidetracked by legal issues; yet ImClone still claims a legitimate cancer blockbuster: Erbitux, the fi rst targeted cancer therapy approved for colorectal cancer. Why have unfavorable results of Amgen' s Vectibix made clinicians, investigators, and investors anxious about Erbitux' s future potential?
- Much excitement accompanied the completion of sequencing the human genome, circa 2000. But the excitement soon gave rise to somber refl ection: the sequencing itself did not immediately point the way to a bevy of new oncology drugs. What work still needs to be done for human genome sequencing to realize its promise of helping to provide personalized, targeted cancer therapies? Scope
Scope
- Cancer therapy today and tomorrow: limitations of the three principal modalities of current cancer treatment; addressing unmet needs; targeted cancer therapy and personalized medicine; changes in the drug development paradigm.
- Leaders in oncology: the world' s best-selling oncology drugs and the key products in 11 leading oncology franchises.
- Oncology pipelines: Amgen' s woes; AstraZeneca' s disappointment; Bristol-Myers Squibb' s expansion; Exelixis' s aggressive discoveries; Genentech/Roche' s leading oncology franchise; Genmab' s waves; GlaxoSmithKline' s oncological advances; ImClone' s legitimate blockbuster; ImmunoGen' s “armed” technology; Novartis' s kinase inhibitors; Pfi zer' s bandwagon-jumping.
- Waves of the future: human genome sequencing; the oncology gold rush; RNA targeted therapies.
- Spectrum expert commentaries: two separate commentaries in which leading oncology experts
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Cancer Therapy Today and Tomorrow
- Targeted Therapy-Hitting Cancer Where it Hurts
- Leaders in Oncology
- Today' s Reality-Diffi culties in Developing Targeted Therapies
- Toxicities and Black Box Warnings
- Personalized Medicine
- Murphy' s Law in Effect
- Key Products in Development
- AstraZeneca' s Initial Disappointment Gives Rise to Changes
- Bristol-Myers Squibb Expands into Biologics
- Exelixis Engages in Aggressive Drug Discovery and Development
- Third-Party Clinical Financing Vehicle
- Small-Molecule Kinase Inhibitors
- Genentech/Roche Lead the Way with Oncology Biologics
- Genmab Makes Waves with Largest European Product Deal Ever
- GlaxoSmithKline Advances into Herceptin' s Space in Breast Cancer
- ImClone Faces Ongoing Strife but Boasts a Legitimate Blockbuster
- ImmunoGen Innovates with Armed Antibody Technology
- Novartis Banks on Small-Molecule Kinase Inhibitors
- Pfi zer Moves Beyond Historical Reliance on Small-Molecule Drug Technologies
- Waves of the Future
- Somber Refl ection on Human Genome Sequencing
- Mainstay Cancer Treatment Circa 2015
- Personalized Targeted Therapies
- Tomorrow' s RNA Targeted Therapies
Spectrum Expert Commentaries:
- “Targeted Oncology Therapy: Trend Toward Personalized Treatment,” by David Z. Chang, M.D., Ph.D., Gastrointestinal Medical Oncology & Immunology, The University of Texas, M.D. Anderson Cancer Center
- “The Potential of MicroRNA Modulators as Targeted Oncology Therapies,” by Fabricio F. Costa, Ph.D., Cancer Biology and Epigenomics Program, Children' s Memorial Research Center, Northwestern University' s Feinberg School of Medicine, and Thomas Wurdinger, Ph.D., Molecular Neurogenetics Unit, Department of Neurology, Massachusetts General Hospital, and Program in Neuroscience, Harvard Medical School
Tables:
- 1. Amgen' s Targeted Oncology Pipeline-Select Products, 2007
- 2. AstraZeneca' s Targeted Oncology Pipeline-Select Products, 2007
- 3. Bristol-Myers Squibb' s Targeted Oncology Pipeline-Select Products, 2007
- 4. Exelixis' s Targeted Oncology Pipeline-Select Products, 2007
- 5. Genentech and Roche' s Combined Targeted Oncology Pipeline-Select Products, 2007
- 6. Genmab' s Targeted Oncology Pipeline-Select Products, 2007
- 7. GlaxoSmithKline' s Targeted Oncology Pipeline-Select Products, 2007
- 8. ImClone' s Targeted Oncology Pipeline-Select Products, 2007
- 9. ImmunoGen' s Targeted Oncology Pipeline-Select Products, 2007
- 10. Novartis' s Targeted Oncology Pipeline-Select Products, 2007
- 11. Pfi zer' s Targeted Oncology Pipeline-Select Products, 2007
Figures:
- 1. Leading Sites of New Cancer Cases and Deaths-2007 Estimates
- 2. Considerations for Successful Anticancer Drug Development
- 3. Best-Selling Oncology Products, 2006 and 2012
- 4. Leading Oncology Franchises-Key Products, 2006
- Expert Commentary. Epidermal Growth Factor Receptor Targeted Drugs
