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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 game 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.

Key benefits, features 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

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

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

The Future of Cancer Immunotherapy: KOL Views Bring Opportunities into Sharp Focus
1.2.There are several types of cancer immunotherapy, but checkpoint inhibitors are 1.3.showing the most promise
1.4.There is a focus on melanoma and lung cancer for immunotherapy RandD
1.5.Clinical trial design will have to be adapted in order for cancer immunotherapies to fully demonstrate their potential in this setting
1.6.Combinations of immunotherapies are the most promising and appealing approach for oncologists
1.7.Cancer immunotherapies: hype or reality?
2.Research objectives and methodology
3.Setting the scene: what is cancer immunotherapy?
3.1.Definitions and history
3.1.2.History to the present day
3.1.3.Recent developments have seen cancer immunotherapy advance significantly
3.1.4.The launch of Yervoy signalled a new era for cancer immunotherapy
3.1.5.Is the excitement around cancer immunotherapy justified?
3.1.6.Lung cancer is a key area of focus for immunotherapeutic development
3.1.7.Today's advances in the development and commercialisation of cancer immunotherapies are just the "tip of the iceberg"
4.Cancer immunotherapy: tumour-immune system interaction, key immunotherapy 4.1.technologies and mechanisms of action
4.2.Tumours, the immune system and their interaction with immunotherapy
4.3.Key immunotherapy technologies
4.4.Mechanisms of action of leading cancer immunotherapies
4.4.1.Interleukin-2 (IL-2) and interferon-alpha (IFN- ?)
4.4.2.Checkpoint inhibitors
4.4.3.CTLA-4 inhibitors
4.4.4.Therapeutic cancer vaccines
4.4.5.Chimeric antigen receptor (CAR) therapy
5. Clinical data summary for key cancer immunotherapies
5.1.Key data for Yervoy (ipilimumab; Bristol-Myers Squibb)
5.1.2.Yervoy in lung cancer
5.2.Key data for nivolumab (BMS-936558; BMS)
5.2.1.Metastatic melanoma
5.2.3.Renal cell carcinoma
5.3.Key data for MPDL3280A (Roche)
5.3.1.Phase I Study of MPDL3280A (Roche) in patients with Locally Advanced or Metastatic Solid Tumours (NCT01375842)
5.3.2.A Phase I study in metastatic urothelial bladder cancer
5.4.Pembrolizumab (MK-3575, Merck and Co.)
5.4.1.Advanced melanoma
5.6.1.Phase I study results of pembrolizumab (MK-3475) in NSCLC
5.6.2.PD-L1 as a predictor or marker of response to pembrolizumab
5.7.Key data for MEDI4736 (AstraZeneca)
6.How cancer immunotherapies potentially fit into current treatment paradigms
6.1.Advanced melanoma
6.1.1.Current protocol
6.1.2.Potential role of immunotherapy in the protocol for melanoma
6.1.3.Checkpoint inhibitors in BRAF mutation tumours
6.2.Protocol for other cancers
6.2.1.Lung cancer

7.Key issues in the clinical development and design of cancer immunotherapies and their trial
7.1.Clinical development endpoints specific to immunotherapy trials
7.2.Immune response criteria
7.3.Landmark Endpoints
7.4.Indications: single or multiple tumour types?
7.5.Combinations of cancer therapies incorporating immunotherapies
7.5.1.Combining different mechanisms of action
7.5.2.Chemotherapy plus immunotherapy
7.5.3.Big opportunities with combinations
7.5.4.Practical issues with combination trials
7.5.5.Which patients will benefit and from which combinations?
7.5.6.Combinations: administer in parallel or sequentially?
8.1.biomarkers in relation to immunotherapy
8.2.Defining the population for immunotherapy: PD-L1
8.3.How reliable are investigational biomarkers?
8.4.Biomarkers in NSCLC
8.5.Other biomarkers
8.6.Payer attitudes toward biomarkers
9.Critical success factors for commercial uptake of cancer immunotherapies
9.1.Education and marketing
9.1.1.Educating the patient
9.1.2.Educating the clinician
9.2.Having a rich and diverse pipeline
9.3.Cost and reimbursement
9.4.Duration of treatment
9.5.Cost as a function of efficacy and survival
9.6.Market expansion
9.7.Influence of the oncology community
10.Analysis and comparison of key late-stage checkpoint inhibitors
10.1.CTLA-4, PD-1 or PD-L1?
10.2.Drug profiles including summary of key data on efficacy, toxicity, and indications
10.3.Comparison of checkpoint inhibitor data both with other checkpoint inhibitors and other forms of cancer therapy
11.Future for cancer immunotherapies: looking ahead to 2020 and beyond
11.1.Data to watch
11.2.Different cancer types, different contexts and combinations
11.3.Immuno-responsive tumours
11.4.Up and coming checkpoint targets
11.5.Future of cancer immunotherapy in lung cancer
11.6.Endpoints over the next 5 years
11.7.Ultimately, what do the experts want and expect to see cancer immunotherapies deliver?
13.KOL panel
14.1.Table 8: Summary of clinical trials with ipilimumab in melanoma, June 2014
14.2.Table 9: Summary of ongoing clinical trials with ipilimumab in NSCLC, June 2014
14.3.Table 10: Summary of ongoing clinical trials with nivolumab, June 2014
14.4.Table 11: Summary of ongoing clinical trials with MPDL3280A, June 2014
14.5.Table 12: Summary of key ongoing clinical trials with pembrolizumab (MK-3475), June 2014

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