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 challengesImmediate 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.

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The Future of Cancer Immunotherapy: KOL Views Bring
Opportunities into Sharp Focus
Published on June 2014
Report Summary
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.
Table of Content
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
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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- ')
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
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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
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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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