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The Future of Cancer Immunotherapy: KOL Views Bring Opportunities into Sharp Focus

出版商 FirstWord 商品編碼 306159
出版日期 內容資訊 英文 122 Pages
商品交期: 最快1-2個工作天內
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未來的癌症免疫療法:關鍵意見領袖的聚焦見解可開創機會 The Future of Cancer Immunotherapy: KOL Views Bring Opportunities into Sharp Focus
出版日期: 2014年07月01日 內容資訊: 英文 122 Pages






  • 定義與歷史
    • 到現在為止的歷史
    • 近年發展讓癌症免疫療法進化
    • Yervoy的上市讓癌症免疫療法邁入新時代
    • 對癌症免疫療法的關切是否具有正當性
    • 肺癌是癌症免疫療法中重要的分類
    • 癌症免疫療法的開發與商業化只是今日發展的"冰山一角"


  • 腫瘤、免疫系統、免疫療法相互作用
  • 主要免疫療法技術
  • 主要癌症免疫療法作用機制
    • 白細胞介素-2與干擾素α
    • 檢查點抑制劑
    • CTLA-4抑制劑
    • 治療用癌症疫苗
    • 嵌入性抗原接受器治療


  • Yervoy相關重要資料
    • 黑色素瘤
    • 肺癌用Yervoy
  • nivolumab相關重要資料
    • 轉移性黑色素瘤
    • 非小細胞肺癌
    • 腎細胞癌
  • MPDL3280Aズ相關重要資料
    • 局部或轉移性固態腫瘤患者的MPDL3280A第1期治療
    • 轉移性尿道皮癌第1期治療
  • Pembrolizumab
    • 進行性黑色素瘤
    • 非小細胞肺癌
    • 非小細胞肺癌pembrolizumab的第1期治療結果
    • PD-L1是對pembrolizumab產生反應的預測因素標記物


  • 進行性黑色素瘤
    • 現在的資料
    • 黑色素瘤資料免疫療法潛在角色
    • BRAF變異腫瘤檢查點抑制劑
  • 其他癌症相關初步資料
    • 肺癌


  • 免疫療法治療特有的臨床開發測試終點
  • 免疫反應基準
  • 里程碑測試終點
  • 適應:單發與多重腫瘤型
  • 免疫療法與癌症治療合併
  • 生物標記物


  • 教育與行銷
    • 對患者的教育
    • 對醫生的教育
  • 具有豐富多樣的臨床測試
  • 成本與償還
  • 治療期間
  • 有效性與生存率相關成本
  • 市場擴大
  • 癌症對社會的影響


  • CTLA-4、PD-1、PD-L1
  • 有效性、毒性、適應相關重要資料摘要包括的藥劑檔案
  • 其他檢查點抑制劑與其他癌症治療法資料比較


  • 需注目資料
  • 各種癌症種類、各種內容與結合
  • 免疫反應性腫瘤
  • 檢查點目標
  • 肺癌未來的免疫療法
  • 今後5年的測試終點
  • 最終專家希望引進怎樣的癌症免疫療法





There has been considerable media hype and clinical interest in cancer immunotherapy in recent years. Indeed, there is talk of late stage cancers such as melanoma and NSCLC being managed as chronic conditions with significant increases in life expectancy. There is even speak of a cure.

But what is the true state of cancer immunotherapy research? Can we really be sure that the promise of early-stage success will be seen in late-stage clinical trials? Importantly, what do leading clinicians think about the products and research and how do they see things playing out in the clinical setting?

Undoubtedly, few research developments in recent years have held such promise to provide a game changing shift in the treatment of cancer. Ever since the launch of Dendreon's Provenge (sipuleucel-T) and, more recently BMS' checkpoint inhibitor Yervoy (ipilimumab), there has been growing knowledge and anticipation that we are on the cusp of a radical new era of cancer management. As one leading KOL puts it "this is nothing less than an explosion in the options for our patients"

Opportunities and challenges

Immediate research interest is focussed on the CTLA-4L, PD1 and PD-L1 classes, with many expected to market in the medium term in a battle between BMS, Merck, Roche and AZ among others. The PD-1 products have shown high-levels of efficacy in trials leading to hitherto unseen therapeutic outcomes in melanoma and NSCLC with the prospect of wider indications to follow as research advances.

But there are challenges too. The expected high costs of therapy will need to be mitigated by the development and use of accurate diagnostic biomarkers - an area still lagging in significant progress. Moreover, current clinical trial protocols are felt to be inappropriate for assessing immunotherapeutics. The disappointing results from Dendreon's Provenge have brought into question the value and role cancer vaccines might play in the treatment mix, though research is ongoing.

It is still early days. How immunotherapeutics will be best utilised is still open to question, though application in combination with other agents and treatment regimes seems to yield the best results.

The bottom line here is that cancer immunotherapies will revolutionise cancer treatment and the fortunes of the companies who bring effective and safe products to the market.

With this report you will:

  • Know the status and prospects of the cancer immunotherapeutics sector
  • Understand the therapeutic approaches and their related drugs
  • Be able to assess the competitive race to market
  • Appreciate the market environment issues which are impacting development of the sector
  • Understand the latest research as reported at ASCO 2014
  • Gain valuable real world insights from leading KOL's active in the cancer immunotherapy field

Key Benefits and Insights

The cancer immunotherapy market is evolving rapidly. In this report, key stakeholders from the pharmaceutical industry, diagnostic biomarker developers, regulatory authorities and health payers will:

  • Gain access to the latest research developments and KOL expert views on current and future products and how they will fit into cancer treatment regimes with trends across a range of topics, from competitive strategy, clinical development, IP, and pricing
  • Appreciate the practical insights of practicing clinicians
  • Understand the regulatory issues which could negatively affect progress and why new clinical trial protocols are required
  • Be aware of the very latest clinical research results from ASCO 2014
  • Learn about the clinical benefits and challenges for CTLA-4L, PD1 and PD-L1 therapeutic approaches including efficacy and toxicity assessments
  • Identify which companies and products are leading the race to be first-to-market
  • Understand how cancer vaccines may fit into the future market
  • Gain insight to the different types of combination therapies which are being examined to secure maximum therapeutic benefit


  • Extensive examination of the therapeutic approaches and products in research
  • Detailed assessment of launched products
  • Current and extensive clinical trial status and results
  • Critical appraisal of research environment related to issues such intellectual property, pricing and biomarkers
  • Insightful commentary and opinions from leading KOLs


  • Which companies are leading the race to be first to market and with what products?
  • How might toxicity affect take up?
  • What type of patients will benefit most?
  • What challenges need to be overcome in the education of clinicians and patients?
  • How regulators need to develop their product review systems when assessing cancer immunotherapies
  • When will the price be too high: balancing the cost/benefit equation?

Table of Contents


  • There are several types of cancer immunotherapy, but checkpoint inhibitors are showing the most promise
  • There is a focus on melanoma and lung cancer for immunotherapy R&D
  • Clinical trial design will have to be adapted in order for cancer immunotherapies to fully demonstrate their potential in this setting
  • Combinations of immunotherapies are the most promising and appealing approach for oncologists
  • Cancer immunotherapies: hype or reality?

Research objectives and methodology

Setting the scene: what is cancer immunotherapy?

  • Definitions and history
    • History to the present day
    • Recent developments have seen cancer immunotherapy advance significantly
    • The launch of Yervoy signalled a new era for cancer immunotherapy
    • Is the excitement around cancer immunotherapy justified?
    • Lung cancer is a key area of focus for immunotherapeutic development
    • Today's advances in the development and commercialisation of cancer immunotherapies are just the "tip of the iceberg"

Cancer immunotherapy: tumour-immune system interaction, key immunotherapy technologies and mechanisms of action

  • Tumours, the immune system and their interaction with immunotherapy
  • Key immunotherapy technologies
  • Mechanisms of action of leading cancer immunotherapies
    • Interleukin-2 (IL-2) and interferon-alpha (IFN- α)
    • Checkpoint inhibitors
    • CTLA-4 inhibitors
    • Therapeutic cancer vaccines
    • Chimeric antigen receptor (CAR) therapy

Clinical data summary for key cancer immunotherapies

  • Key data for Yervoy (ipilimumab; Bristol-Myers Squibb)
    • Melanoma
    • Yervoy in lung cancer
  • Key data for nivolumab (BMS-936558; BMS)
    • Metastatic melanoma
    • NSCLC
    • Renal cell carcinoma
  • Key data for MPDL3280A (Roche)
    • Phase I Study of MPDL3280A (Roche) in patients with Locally Advanced or Metastatic Solid Tumours (NCT01375842)
    • A Phase I study in metastatic urothelial bladder cancer
  • Pembrolizumab (MK-3575, Merck & Co.)
    • Advanced melanoma
    • Phase I study results of pembrolizumab (MK-3475) in NSCLC
    • PD-L1 as a predictor or marker of response to pembrolizumab
  • Key data for MEDI4736 (AstraZeneca)

How cancer immunotherapies potentially fit into current treatment paradigms

  • Advanced melanoma
    • Current protocol
    • Potential role of immunotherapy in the protocol for melanoma
    • Checkpoint inhibitors in BRAF mutation tumours
  • Protocol for other cancers
    • Lung cancer

Key issues in the clinical development and design of cancer immunotherapies and their trials

  • Clinical development endpoints specific to immunotherapy trials
  • Immune response criteria
  • Landmark Endpoints
  • Indications: single or multiple tumour types?
  • Combinations of cancer therapies incorporating immunotherapies
    • Combining different mechanisms of action
    • Chemotherapy plus immunotherapy
    • Big opportunities with combinations
    • Practical issues with combination trials
    • Which patients will benefit and from which combinations?
    • Combinations: administer in parallel or sequentially?
  • Biomarkers
    • Key biomarkers in relation to immunotherapy
    • Defining the population for immunotherapy: PD-L1
    • How reliable are investigational biomarkers?
    • Biomarkers in NSCLC
    • Other biomarkers
    • Payer attitudes toward biomarkers

Critical success factors for commercial uptake of cancer immunotherapies

  • Education and marketing
    • Educating the patient
    • Educating the clinician
  • Having a rich and diverse pipeline
  • Cost and reimbursement
  • Duration of treatment
  • Cost as a function of efficacy and survival
  • Market expansion
  • Influence of the oncology community

Analysis and comparison of key late-stage checkpoint inhibitors

  • CTLA-4, PD-1 or PD-L1?
  • Drug profiles including summary of key data on efficacy, toxicity, and indications
  • Comparison of checkpoint inhibitor data both with other checkpoint inhibitors and other forms of cancer therapy

Future for cancer immunotherapies: looking ahead to 2020 and beyond

  • Data to watch
  • Different cancer types, different contexts and combinations
  • Immuno-responsive tumours
  • Up and coming checkpoint targets
  • Future of cancer immunotherapy in lung cancer
  • Endpoints over the next 5 years
  • Ultimately, what do the experts want and expect to see cancer immunotherapies deliver?


KOL panel


  • Table 8: Summary of clinical trials with ipilimumab in melanoma, June 2014
  • Table 9: Summary of ongoing clinical trials with ipilimumab in NSCLC, June 2014
  • Table 10: Summary of ongoing clinical trials with nivolumab, June 2014
  • Table 11: Summary of ongoing clinical trials with MPDL3280A, June 2014
  • Table 12: Summary of key ongoing clinical trials with pembrolizumab (MK-3475), June 2014
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