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:
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
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.
Table of Contents
for The Future of Cancer Immunotherapy: KOL Views Bring Opportunities into Sharp Focus [Published by FirstWord Pharma]
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 R&D
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- α)
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)
5.2.3.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 & Co.)
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
6.1.2.Potential role of immunotherapy in the protocol for melanoma
6.1.3.Checkpoint inhibitors in BRAF mutation tumours
6.2.Protocol for other cancers
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
7.4.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
8.6.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
9.7.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
11.4.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?
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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This report is published by FirstWord Pharma
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