Prostate Cancer: KOL Insight

October 2015 | | ID: P09F060F62EEN
FirstWord

Abstracts

The last decade has seen significant change in how prostate cancer is treated. Innovation and lifecycle management have each played a role in shaping today’s treatment paradigm. But how will results from landmark studies such as STAMPEDE and CHAARTED impact current treatment decisions? And which products will emerge victorious in the battle for market share?

Prostate Cancer: KOL Insight looks at the future of prostate cancer therapy and provides insight from 12 leading North American and European KOLs. How will marketed and late-stage pipeline drugs continue to be used?

Answering Key Questions

• Androgen inhibitors
• Marketed Therapies
• Xtandi (enzalutamide; Astellas/Medivation). Will this drug be used in earlier treatment settings, e.g. high-risk non-metastatic disease?
• Zytiga (abiraterone acetate; Johnson & Johnson). Is the need for corticosteroid co-administration a competitive disadvantage? And could it play a role in metastatic hormone-naïve prostate cancer?
• Pipeline Therapies
• Apalutamide (JNJ-927/ARN-509; Johnson & Johnson). Can this drug differentiate itself in an increasingly competitive market? Will its potential side-effect advantages increase its long-term potential?
• Galeterone (TOK-001; Tokai). Will biomarker-led selection help it find its place, particularly for patients with resistance to other treatments? Or will it lose out to treatments for wider patient populations
• Bone-targeted therapies
• Marketed drugs
• Xgeva (denosumab; Amgen). Will more targeted drug use earlier in the treatment algorithm reduce uptake of Xgeva in the longer term? In the shorter term, is cost slowing adoption?
• Xofigo (radium-223 dichloride; Algeta/Bayer). Is this drug being used too late in the treatment algorithm to maximise its effectiveness?
• Immunotherapies/
• Marketed drugs/
• Provenge (sipuleucel-T; Valeant). Ambivalence toward Provenge remains high amongst US oncologists; is it an under-appreciated option or do logistics and costs preclude wider uptake?
• Pipeline drugs
• DCVAC/PCa (dendritic cell-based vaccine; Sotio). Will the fact that it’s simpler to administer than Provenge offer a chance of success?
• ProstAtak (Advantagene). KOL interest is high, but will concerns about Phase III study design affect how it’s viewed?
• Prostvac (rilimogene galvacirepvec-rilimogene glafolivec; Bavarian Nordic/Bristol-Myers Squibb). With Provenge not living up to expectations, will vaccine treatments suffer by association until trial results are clear?
• Yervoy (ipilimumab; Bristol-Myers Squibb). With two failed trials casting a shadow, will finding a specific patient group that is responsive in early disease be key to success?
• Other new therapies
• Pipeline drugs
• Custirsen (OGX-011; OncoGenex/Teva). Will the failure to reach its primary overall survival endpoint in the SYNERGY trial outweigh the hope of finding an appropriate sub-group for treatment?
• Masitinib (AB-1010; AB Science). Will results from small-scale trials and toxicity worries be too high a hurdle for this treatment to overcome?
• ODM-201 (BAY 1841788; Bayer/Orion). Can this therapy find a foothold in the non-metastatic castration-resistant prostate cancer setting?

Top takeaways

• A new gold standard of care has emerged: Results from the STAMPEDE and CHAARTED trials have already transformed first-line treatment
• Earlier use of targeted treatments will drive treatment paradigm change: KOLs are predicting that some drugs will move up the treatment paradigm
• New indications expected for existing treatments: In an increasingly competitive market, some brands are looking to establish a foothold in undertreated populations
• Tolerability is a key concern for combination treatments: Uncertainty whether the benefits of combination therapies outweigh potential drawbacks
• Further change expected as more targeted treatments are developed: Trial results eagerly anticipated for therapies offering new mechanisms of action, including biomarker-driven therapy
• The future of vaccines remains unclear: KOLs share mixed opinions on the place for vaccines
• Concerns over trial design persist: Calls for more innovative trials to meet current challenges

Key issues explored

• Identifying remaining unmet needs by patient population, and clarifying which treatments are most likely to be able to capitalise on these opportunities
• The impact of the CHAARTED and STAMPEDE trials on the evolving treatment paradigm
• The differences in current and evolving treatment choices for metastatic and non-metastatic disease
• Factors affecting the choice of combination therapies, and how fears of creating very resistant tumours are influencing treatment decisions
• The changing nature of endpoints in prostate cancer clinical trials, and whether these will be acceptable to physicians and payers
• How marketed and pipeline therapies stack up in terms of tolerability, safety and efficacy, and which trials should be monitored

Contributors

KOLs from North America

• Andrew J Armstrong; Associate Professor of Medicine and Surgery and Medical Oncologist at Duke University and the Duke Cancer Institute, Durham, NC.
• David E. Crawford; Professor of Surgery, Urology, and Radiation Oncology, and head of the Section of Urologic Oncology at the University of Colorado, Aurora, CO.
• Michael R. Harrison; Assistant Professor of Medicine and Member of the Duke Cancer Institute, Department of Medicine, Duke University School of Medicine, Durham, NC
• Ashley E. Ross; Assistant Professor of Urology, Oncology and Pathology, Johns Hopkins School of Medicine, Baltimore, MD.
• Neha Vapiwala; Associate Professor and the Vice Chair of Education in the Department of Radiation Oncology at University of Pennsylvania, PA
• Michael J. Zelefsky; Vice Chair, Department of Radiation Oncology, Clinical Research; Chief, Brachytherapy Service, Memorial Sloan Kettering Cancer Center, NY

KOLs from Europe

• Raffaele Ardito; Head of the Day Oncology Unit at Referral Cancer Center of Basilicata, Rionero in Vulture, Italy
• Amit Bahl; Consultant Clinical Oncologist, Clinical Director, Bristol Haematology & Oncology Centre, University Hospitals Bristol, UK
• Nicolas B. Delongchamps; Consultant, Cochin Hospital in Paris and Professor at Paris Descartes’s University, France
• John P. Logue; Consultant Clinical Oncologist, The Christie Clinic, Manchester, UK
• Anonymous German KOL; University Professor and Clinical Head of a Urology Clinic
• Anonymous German KOL; University Professor and Medical Director at a University Clinic of Urology

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Contents

1. EXECUTIVE SUMMARY

2,RESEARCH OBJECTIVES

3,RESEARCH FOCUS 5 REPORT FOCUS

3.1. The impact of the CHAARTED and STAMPEDE trials

4. ANDROGEN INHIBITORS 15 OVERVIEW 15 MARKETED DRUGS

4.1. Xtandi (enzalutamide; Astellas/Medivation)
4.2. Zytiga (abiraterone acetate; Johnson & Johnson)
4.3. Pipeline drugs
4.4. Apalutamide (JNJ-927/ARN-509; Johnson & Johnson)
4.5. ODM-201 (BAY 1841788; Bayer/Orion)
4.6. Galeterone (TOK-001; Tokai)

5. BONE-TARGETED THERAPIES

5.1. Overview
5.2. Marketed drugs
5.3. Xofigo (radium-223 dichloride; Algeta/Bayer)
5.4. Xgeva (denosumab; Amgen)

6. IMMUNOTHERAPIES

6.1. Overview
6.2. Marketed drugs
6.3. Provenge (sipuleucel-T; Valeant)
6.4. Pipeline drugs
6.5. Yervoy (ipilimumab; Bristol-Myers Squibb)
6.6. Prostvac (rilimogene galvacirepvec-rilimogene glafolivec;
Bavarian Nordic/Bristol-Myers Squibb)
6.7. DCVAC/PCa (dendritic cell-based vaccine; Sotio)
6.8. ProstAtak (Advantagene)

7. OTHER NEW THERAPIES

7.1. Pipeline drugs
7.2. Custirsen (OGX-011; OncoGenex/Teva)
7.3. Masitinib (AB-1010; AB Science)

8. CONCLUSION

9. APPENDIX

9.1. KOL biographies
9.2. KOLs from North America
9.3. KOLs from the EU