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

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Publication Date:
June 2014
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Immuno-oncology is set to bring disruptive innovation to the field of cancer treatment. There is talk of late stage cancers such as melanoma and NSCLC being managed as chronic conditions with significant increases in life expectancy. And there is even talk of a cure.

But with high expectations for new immuno-oncology drugs,  there is a need to understand what the true potential each new drug has to transform the market.

The Future of Cancer Immunotherapy: KOL Views Bring Opportunities into Sharp Focus report cuts through the hype to deliver authoritative, original insight into the drugs and companies that are poised to revolutionise the oncology therapy landscape.

Includes Latest ASCO Data

Key benefits, features and insights

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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
  • 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

Key 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

Key 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?

KOL Panel

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Incisive questions. Expert answers. Critical insights

This report examines the key developments in cancer immunotherapy and examines the research and products that are the focus of attention. It includes from the most prominent cancer KOL’s in Europe and the US whose knowledge and practical clinical experience and involvement means their insights and opinions need to be considered carefully by drug developers.

  • Dirk Schadendorf, MD, Director for the Dermatology Clinic, University of Essen, Essen, Germany
  • Hossein Borghaei, DO, Chief, Thoracic Medical Oncology, Director, Lung Cancer Risk Assessment, Fox Chase Cancer Center, Philadelphia, PA, USA
  • Julie R. Brahmer, MD, MSc Associate Professor of Oncology Sidney Kimmel Comprehensive Cancer Center Johns Hopkins University, Baltimore, MD, USA
  • Michael B. Atkins, MD, Deputy Director, Georgetown-Lombardi Comprehensive Cancer Center, Washington DC, USA
  • Michael Postow MD. Assistant Attending Physician, Melanoma-Sarcoma Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY, USA
  • Paolo A. Ascierto, MD, Cancer Immunotherapy and Innovative Therapy Unit Istituto Nazionale Tumori Fondazione ‘G. Pascale,' Naples, Italy
  • Anonymous, Lung cancer specialist, Los Angeles, CA, USA
  • Anonymous, Melanoma specialist, Pittsburgh, PA, USA

Table of Contents

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        • 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 trial
        • 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?
        • 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