市場調査レポート

将来の癌の免疫療法:キーオピニオンリーダーの見解が絞り込んだ焦点に機会をもたらす

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

発行 FirstWord 商品コード 306159
出版日 ページ情報 英文 122 Pages
納期: 即日から翌営業日
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将来の癌の免疫療法:キーオピニオンリーダーの見解が絞り込んだ焦点に機会をもたらす The Future of Cancer Immunotherapy: KOL Views Bring Opportunities into Sharp Focus
出版日: 2014年07月01日 ページ情報: 英文 122 Pages
概要

近年、癌の免疫療法はメディアに大々的に取り上げられ、臨床的に関心が寄せられています。実際にメラノーマや非小細胞肺癌などの末期癌の慢性疾患管理において寿命を大きく伸ばす効果があります。癌の免疫療法市場は急速に発展しています。

当レポートでは、癌の免疫療法に関する現状と将来的見通し、治療法と関連薬剤、市場の競合動向、同分野におけるキーオピニオンリーダーの見解などをまとめています。

ハイライト

調査目的と方法

現状:癌の免疫療法とは

  • 定義と歴史
    • 現在までの歴史
    • 近年の発展が癌の免疫療法を大きく進化させた
    • Yervoyの上市が癌の免疫療法の新たな時代に
    • 癌の免疫療法への注目は正当性があるか
    • 肺癌は癌の免疫療法の重要な注目分野
    • 癌の免疫療法の開発と商業化における今日の発展は"氷山の一角"に過ぎない

癌の免疫療法:腫瘍と免疫系との相互作用、重要な免疫療法技術、作用機序

  • 腫瘍、免疫系、および免疫療法によるそれらの相互作用
  • 主な免疫療法技術
  • 主な癌の免疫療法の作用機序
    • インターロイキン2およびインターフェロンα
    • チェックポイント阻害剤
    • CTLA-4阻害剤
    • 治療用癌ワクチン
    • キメラ抗原受容体治療

癌の免疫療法に関する臨床データサマリー

  • Yervoyに関する重要データ
    • メラノーマ
    • 肺癌におけるYervoy
  • nivolumabに関する重要データ
    • 転移性メラノーマ
    • 非小細胞肺癌
    • 腎細胞癌
  • MPDL3280Aに関する重要データ
    • 局所的に進行した、または転移性の固形腫瘍を患う患者におけるMPDL3280Aの第1相治験
    • 転移性尿路上皮癌における第1相治験
  • Pembrolizumab
    • 進行性メラノーマ
    • 非小細胞肺癌
    • 非小細胞肺癌におけるpembrolizumabの第1相治験結果
    • pembrolizumabに反応する予測因子マーカーとしてのPD-L1

癌の免疫療法は現在の治療パラダイムにどのように合致する可能性があるか

  • 進行性メラノーマ
    • 現在のプロトコル
    • メラノーマのプロトコルにおける免疫療法の潜在的役割
    • BRAF変異腫瘍におけるチェックポイント阻害剤
  • 他の癌に関するプロトコル
    • 肺癌

癌の免疫療法の臨床開発およびデザイン、その治験における課題

  • 免疫療法治験に特有の臨床開発エンドポイント
  • 免疫反応基準
  • ランドマークエンドポイント
  • 適応:単発か多重腫瘍型か
  • 免疫療法を組み込んだ癌治療の併合
  • バイオマーカー

癌の免疫療法を商業化するための重要成功因子

  • 教育とマーケティング
    • 患者への教育
    • 医師への教育
  • 豊富なかつ多様なパイプラインをもつこと
  • コストと償還
  • 治療の期間
  • 有効性と生存率の関数としてのコスト
  • 市場拡大
  • 癌コミュニティの影響

後期チェックポイント阻害剤の分析と比較

  • CTLA-4、PD-1、PD-L1
  • 有効性、毒性、適応に関する重要データのサマリーを含む薬剤プロファイル
  • 他のチェックポイント阻害剤および他の癌治療法とのデータ比較

将来の癌免疫療法:2020年までの見通しとそれ以降

  • 注目すべきデータ
  • 様々な癌の種類、様々な内容と結合
  • 免疫反応性腫瘍
  • チェックポイントの標的
  • 肺癌における将来的免疫療法
  • 今後5年間のエンドポイント
  • 最終的に専門家は癌の免疫療法を導入したいと考えるか

結論

キーオピニオンリーダー委員会

付録

目次

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

Features

  • 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

Insights

  • 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

Highlights

  • 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
  • NSCLC
    • 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?

Conclusion

KOL panel

Appendix

  • 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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