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前立腺癌:KOL (キーオピニオンリーダー) による分析

Prostate Cancer: KOL Insight

発行 FirstWord 商品コード 268897
出版日 ページ情報 英文
納期: 即日から翌営業日
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前立腺癌:KOL (キーオピニオンリーダー) による分析 Prostate Cancer: KOL Insight
出版日: 2015年11月01日 ページ情報: 英文



当レポートでは、前立腺癌の上市済み薬剤および開発中の薬剤について調査し、前立腺癌の治療法の変化、治療の選択肢、STAMPEDEおよびCHAARTED試験とその影響、併用療法と懸念、アンメットニーズなどについて、米国および欧州の12名のキーオピニオンリーダー (KOL) による各種見解をまとめています。


  • アンドロゲン阻害剤
    • 上市済み薬剤
      • Xtandi (enzalutamide; アステラス/Medivation)
      • Zytiga (abiraterone acetate; Johnson & Johnson)
    • パイプライン薬剤
      • Apalutamide (JNJ-927/ARN-509; Johnson & Johnson)
      • Galeterone (TOK-001; Tokai)
  • 骨標的療法
    • 上市済み薬剤
      • Xgeva (denosumab; Amgen)
      • Xofigo (radium-223 dichloride; Algeta/Bayer)
  • 免疫療法
    • 上市済み薬剤
      • Provenge (sipuleucel-T; Valeant)
    • パイプライン薬剤
      • DCVAC/PCa (dendritic cell-based vaccine; Sotio)
      • ProstAtak (Advantagene)
      • Prostvac (rilimogene galvacirepvec-rilimogene glafolivec; Bavarian Nordic/Bristol-Myers Squibb)
      • Yervoy (ipilimumab; Bristol-Myers Squibb)
  • その他の新しい療法
    • パイプライン薬剤
      • Custirsen (OGX-011; OncoGenex/Teva)
      • Masitinib (AB-1010; AB Science)
      • ODM-201 (BAY 1841788; Bayer/Orion)


  • 患者人口によるアンメットニーズの特定とこれらの機会をもっとも収益化できる治療法の特定
  • CHAARTED・STAMPEDE試験の進化する治療パラダイムへの影響
  • 転移性・非転移性疾患の現在・将来の治療の選択肢
  • 併用療法の選択への影響因子・高い薬剤耐性を持つ腫瘍の増殖の恐れと治療の選択への影響
  • 前立腺癌の臨床試験のエンドポイントの性質の変化と医師・医療費支払い者による受容度
  • 上市済み&パイプライン治療薬の耐性、安全性、有効性の強みと注目すべき臨床試験
Product Code: 596200417

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?


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 explorede

  • 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


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

Ongoing Benefits

The world of pharma is ever changing and executives must always be up-to-date with new developments that could affect their own products, position and research. That is why FirstWord's guarantee to keep Therapy Trends clients up to date with Update Bulletins offers a real commercial advantage.

Update Bulletins include expert insight and analysis based on FirstWord analyst re-engagement with the KOLs after major events such as product approvals, key data releases and major conferences to deliver the most valuable insights with each update.

  • Your Therapy Trends Report purchase entitles you to receive three Update Bulletins, which are published approximately every three months for 12 months following the report's publication date, October 2014.
  • You will receive a copy of each Update Bulletin once available, which are issued each quarter after the publication date.
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