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  4. > Non-small cell lung cancer: Game changing immunotherapies to revolutionise treatment - KOL Insight

Change is coming to the NSCLC treatment algorithm—and it’s coming soon. Revolutionary new immunotherapies, more personalised treatment choices and further drug developments are all set to roll out in the near future. What are the potential blockbusters, who will gain approvals first and what are the future challenges?

Drivers of change

- Revolutionary immunotherapies. From cancer vaccines to checkpoint inhibitors, several therapies in late-stage development are due to launch very soon. According to KOLs interviewed, the most promising are programmed cell death protein 1 (PD-1) pathway inhibitors. The race is on between Bristol-Myers Squibb’s nivolumab, Merck & Co.’s MK-3475 and Roche’s RG7446 to become the first to be approved.
- Mutation analysis. Personalised targeted therapy has been a paradigm shift towards assessing patients’ treatment based on mutation status. Leading the way is Xalkori (crizotinib; Pfizer) with its associated Anaplastic Lymphoma Kinase (ALK)-testing diagnostic—yet it faces pending competition from several other therapies in early- to late-stage development.
- Key opportunities in EGFR resistance. Since patients all develop resistance to currently marketed EGFR inhibitors, significant opportunities exist in developing a therapy to tackle the T790 mutation responsible for approximately half of acquired resistance cases. While pipeline therapies have not yet proven they have the answer, KOLs believe early phase 1 results from Clovis’s CO-1686 position it well.

Unique insider clinical opinion

Comprehensive, concise and offering rare access to the most forward-thinking KOL analysis of NSCLC treatments, development and competition, KOL Insight: Non-small cell lung cancer is an essential tool for keeping abreast of events that will shape the future.

Based on in-depth interviews with 12 experienced and highly-regarded KOLs across North America and Europe, the report provides the latest insights into the current and future treatment landscapes. Chosen for their unique abilities, clinical experience, publications and treatment guideline development as well as presence on the international stage, the KOLs bring incisive, real-world analysis of NSCLC treatment.

Pressing issues and questions:

- Which drug attributes create a first- and subsequent-line treatment preference for patients who are EGFR mutation positive, EML4-ALK translocation positive and EGFR mutation/ EML4-ALK translocation negative?
- How are current targeted NSCLC therapies perceived by clinicians in terms of efficacy, tolerability, ease of administration, and other product attributes?
- Which recently completed or ongoing clinical trials have the greatest potential to impact the future treatment of NSCLC, e.g. the REVEL, SELECT-1, MAGRIT, LUME LUNG 1, ARCHER 1050 and CheckMate 057 trials?
- What do pipeline NSCLC targeted therapies need to show in order to become the treatment of choice in a specific patient segment and line of therapy?
- How will the use of each current and pipeline NSCLC product change in the future in terms of patient segment, line of therapy and preference?

Key benefits

Developments in the treatment of NSCLC are progressing rapidly. In KOL Insight: Non-small cell lung cancer, you will:

- Gain an invaluable overview into the most dynamic areas of the NSCLC market

- Understand the role of Pfizer’s Xalkori in mutation analysis and personalised treatment therapy

- Obtain insight into why KOLs view EGFR resistance as the largest opportunity for developers—and why Clovis’s CO-1686 may be well-positioned
- Understand why competition will grow in first- and second-line settings for Avastin and Alimta

This report will allow you to:

- View the spectrum of NSCLC treatments and KOL opinion of emerging clinical data

- Analyse current and future treatment algorithms

- Identify promising late-stage drug developments

- Track KOL opinion continuously over the next 12 months

- Understand which drugs are most vulnerable to competition and which upcoming therapies will address unmet needs

KOL Panel

KOLs from North America:

- Dr Paul Bunn, Distinguished Professor, Division of Medical Oncology/University of Colorado, USA.

- Dr Giuseppe Giaccone, Associate Director for Clinical Research, Lombardi Comprehensive Cancer Center (LCCC) at Georgetown University, Washington, DC, USA.

- Dr Leora Horn, Assistant Professor of Medicine (Haematology/Oncology) and Clinical Director of the Thoracic Oncology Program at Vanderbilt-Ingram Cancer Center, Tennessee. USA.

- Dr Patrick Ma, Translational Hematology and Oncology Research and Director of the Aerodigestive Oncology Translational Research THOR Cleveland Clinic Taussig Cancer Center, Ohio, USA.

- Dr Joan Shiller, deputy director of the Simmons Comprehensive Cancer Center and division director of Hematology/Oncology at the University of Texas-Southwestern Medical Center, Texas, USA.

- Prof Mark Socinski, professor of medicine and thoracic surgery at the University of Pittsburgh School of Medicine, Pennsylvania, USA.

KOLs from Europe:

- Dr Ahmed Awada, Professor and Head of the Medical Oncology Clinic, Jules Bordet Institute, Brussels & Free Universities, Brussels, Belgium.

- Dr Cesare Gridelli, Chief of Division of Medical Oncology and Director of Department of Oncology/Hematology at the “S.G. Moscati” Hospital, Avellino, Italy.

- Dr Silvia Novello, Assistant Professor of Respiratory Medicine at the Department of Clinical and Biological Sciences of the University of Turin, Orbassano, Italy.

- Dr Solange Peters, head of thoracic malignancies program in the Department of Oncology of the University of Lausanne, Switzerland.

- Dr Egbert Smit, VU University Medical Center, Amsterdam, The Netherlands.

- Dr Nick Thatcher, previously held the post of Professor of Medical Oncology at the Christie Hospital NHS Trust in Manchester, England.

Key Quotes from the Report

“Crizotinib [Xalkori] was actually originally developed with the intent to be a c-Met inhibitor and now the rest is history. It’s an excellent ALK inhibitor.” US Key Opinion Leader

“The Novartis drug [LDK378] looks quite good; it’s got some different toxicities but has demonstrated it does work in crizotinib resistant patients. We don’t yet know if it is better than crizotinib on the brain metastases, which seems to be a relapse problem for crizotinib-treated patients – but there could be some benefits there.” EU Key Opinion Leader

“I think based on the selumetinib phase II data, I think there will be a benefit in terms of outcome. I don’t know about survival but I’m sure that the response to the chemo, the docetaxel will be better when you combine it with a MEK inhibitor in KRAS mutated patients. So I consider SELECT-1 will be a positive trial in terms of outcome. ” EU Key Opinion Leader

“Bristol-Myers Squibb has the most advanced immunotherapy. It will probably be placed in most lines of treatment if it works. A first-line treatment in combination with chemo, combined with targeted agents for patients with mutations and they will also be used as single agents when everything else has failed. Nivolumab will be the first to really change the panorama of non-small cell lung cancer treatment.” US Key Opinion Leader

“I think that the best companies with the best knowledge in oncology can make huge mistakes. So I really don’t think Merck’s lesser grounding in the oncology area will put it at a disadvantage. They just have to equip themselves with a good advisory board and to be intelligent in the way they formulate their clinical trials.” EU Key Opinion Leader

Always up to date

The world of pharma is ever changing and executives must always be up-to-date with the latest developments that could affect their own products, position and research. That is why FirstWord’s guarantee to keep Therapy Trends clients up to date with the latest insight offers a real commercial advantage.

Consider the benefits:

- Significant market events such as new product approvals or pivotal research results will always be followed by a new wave of Therapy Trends primary market research with preeminent KOLs
- Each wave of research provides Therapy Trends clients with fresh expert insights on the likely impact of the latest market developments
- Therapy Trends clients get access to the results of each wave of event-driven primary research through Research Update Bulletins – brief report that bring the impact of the latest events into sharp focus
- There is no limit to the number of events Therapy Trends will cover in a 12 month period
- All updates are included in the price.

Whatever happens in the market you’ll always be able to assess the impact with FirstWord Therapy Trends

Table Of Contents

Non-small cell lung cancer: Game changing immunotherapies to revolutionise treatment - KOL Insight
1.Executive summary
2.Research Objectives
3.Research Focus
4.EGFR mutation positive
4.1.2.Pivotal trial data
4.1.3.Key trials to watch
4.2.Marketed drugs
4.2.1.Tarceva (erlotinib; Roche/Astellas)
4.2.2.Iressa (gefitinib; AstraZeneca)
4.2.3.Gilotrif (afatinib; Boehringer Ingelheim)
4.3.Pipeline drugs
4.3.1.PF-00299804 (dacomitinib; Pfizer/SFJ Pharmaceuticals)
4.3.2.Necitumumab (Eli Lilly)
4.3.3.CO-1686 (Clovis Oncology, Inc)
4.4.EGFR mutation positive current and future treatment algorithm
5.EML4-ALK positive
5.1.1.Pivotal trial data
5.1.2.Key trials to watch
5.2.Marketed drugs
5.2.1.Xalkori (crizotinib; Pfizer)
5.3.Pipeline drugs
5.3.1.LDK378 (Novartis)
5.4.EML4-ALK positive current and future treatment algorithm
6.EML4-ALK and EGFR mutation negative
6.1.1.Pivotal trial data
6.1.2.Key trials to watch
6.2.Marketed drugs
6.2.1.Avastin (bevacizumab; Roche/Genentech/Chugai)
6.2.2.Alimta (pemetrexed; Eli Lilly)
6.3.Pipeline drugs
6.3.1.Nintedanib (BIBF 1120; Boehringer Ingelheim)
6.3.2.Cyramza (ramucirumab/IMC-1121B; Eli Lilly)
6.3.3.Votrient (pazopanib; GlaxoSmithKline)
6.3.4.Halaven (eribulin; Eisai)
6.3.5.AZD6244 (selumetinib; AstraZeneca)
6.3.6.ARQ 197 (tivantinib; ArQule/Daiichi Sankyo/Kyowa Hakko Kirin)
6.4.EML4-ALK and EGFR mutation negative current and future treatment algorithm
7.1.1.Key trials to watch
7.2.Pipeline drugs
7.2.1.Nivolumab (BMS-936558; Bristol-Myers Squibb/Ono Pharmaceuticals)
7.2.2.MK-3475 (Merck and Co.)
7.2.3.RG7446 (Roche)
7.2.4.GSK1572932A (MAGE-A3 ASCI; GlaxoSmithKline/Agenus)
7.2.5.Yervoy (ipilimumab; Bristol-Myers Squibb)
7.2.6.L-BLP25 (tecemotide; Merck KGaA)
7.3.Immunotherapy future treatment algorithm
8.1.KOL biographies
8.1.1.KOLS from North America
8.1.2.KOLs from Europe

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