Therapy Trends KOL Insight: Head and Neck Squamous Cell Carcinoma [2019]

KEYNOTE-048 has broken new ground. What comes next in HNSCC?

KEYNOTE-048 has made headlines in HNSCC. Could these data for Keytruda transform the first-line treatment of recurrent/metastatic disease? KOLs delve into the details of these findings, including potential implications for Opdivo/Yervoy and the CheckMate-651 trial. Curative settings are also fast becoming a key focus for clinical development of immune checkpoint inhibitors; but how promising is this opportunity and how do the experts rate the prospects for Merck & Co., BMS, Roche, AstraZeneca and Merck Group/Pfizer to capture this space? Furthermore, with multiple therapies demonstrating novel mechanisms of action in the pipeline, such as TT10, danvatirsen, M7824 and olaparib, the KOLs provide insight on their potential to succeed in an increasing complex landscape.  In this report, twelve KOLs offer candid insights on three marketed and nine Phase II/III therapies, as well as early development programmes.

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• The table of contents >
• The key business questions answered >
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• See the therapies covered >
• Find out who the 6 EU & 6 US KOLs are >
• Review an extract from the report - 1 drug profile >

• Positive findings from KEYNOTE-048 have broken new ground in HNSCC. How will the single-agent and combination data impact treatment and what are the potential caveats to the first-line use of Keytruda?
• CheckMate-651 is evaluating Opdivo/Yervoy in the first-line recurrent/metastatic setting. What expectations do KOLs hold for this trial and the potential of Opdivo/Yervoy to compete with Keytruda?
• Could curative settings become the next battleground for the immune checkpoint inhibitors? With Merck & Co., BMS, Roche, AstraZeneca and Merck Group/Pfizer all investing in this area, who could emerge victorious?
• Which settings will provide the most significant opportunities for atezolizumab, durvalumab and avelumab in an increasingly complex treatment algorithm? What factors could heighten their chances of success?
• Could EBV-specific T-cells constitute an effective therapy for nasopharyngeal carcinoma? What potential barriers could curtail the widespread use of Tessa Therapeutics’ TT10 in HNSCC therapy and how could they be mitigated?
• Negative data from RTOG-1016 and De-ESCALaTE and increasing competition pose significant threats to Erbitux. But where could opportunities open up in this increasingly challenging environment?
• How do KOLs view the early clinical data for the anti-STAT3 therapy danvatirsen, in combination with durvalumab, and the bifunctional TGFβ/PD-L1 fusion protein M7824? Could these novel approaches impact treatment practice?
• The use of molecular biomarkers has not previously been instrumental in guiding treatment decisions in HNSCC. How could this change in the face of the rapid evolution of therapeutic options?

“Almost everybody wants to use pembrolizumab upfront and start testing for that ahead of the FDA approval if it was possible. We also think it’s a much better option than EXTREME due to its great tolerability. There’s a tremendous amount of enthusiasm.”
US Key Opinion Leader

“You’re going to see them [PD-1/L1 inhibitors] integrated into attempts to cure. There will be neoadjuvant approaches, combinations with radiation in a definitive setting, combinations in the definitive and adjuvant setting. I think you'll see multiple of those be positive and these agents moving to curative settings and therefore not having play in the metastatic/recurrent setting.”
US Key Opinion Leader

Marketed Therapies

• Keytruda (pembrolizumab; Merck & Co.)
• Opdivo (nivolumab; Bristol-Myers Squibb)
• Erbitux (cetuximab; Eli Lilly/Merck Group)

Pipeline Therapies

• atezolizumab (Tecentriq; Roche)
• durvalumab (Imfinzi; AstraZeneca)
• avelumab (Bavencio; Merck Group/Pfizer)
• TT10 (EBV-specific T-cells; Tessa Therapeutics)
• ASP-1929 (Rakuten Medical)

Phase II Therapies

• olaparib (Lynparza; AstraZeneca/Merck & Co.)
• danvatirsen (AZD9150; AstraZeneca/Ionis)
• M7824 (bintrafusp alfa; Merck Group/GSK)
• LN-145 (TIL therapy; Iovance)

KOLs from North America

• Catherine Azar, Medical Oncologist, Clinical Associate Professor of Medicine at the University of Arizona, Tucson, AZ
• Laura Chow, Professor and Associate Director of Phase I Clinical Trials Program, Fred Hutchinson Cancer Research Center, University of Washington School of Medicine, Seattle, WA
• Krzysztof Misiukiewicz, Associate Professor of Medicine, Hematology and Medical Oncology and Assistant Professor in Otolaryngology, Icahn School of Medicine at Mount Sinai, New York, NY
• Rafael Santana-Davila, Associate Professor and Assistant Member of Clinical Research Division at the Fred Hutchinson Cancer Research Center, University of Washington School of Medicine, Seattle, WA
• Tanguy Seiwert, Assistant Professor of Medicine, University of Chicago Medicine, Chicago, IL
• Jared Weiss, Associate Professor of Medicine, University of North Carolina, Chapel Hill, NC

KOLs from Europe

• Shreerang Bhide, Consultant Clinical Oncologist, The Royal Marsden Hospital and The Institute of Cancer Research, London, UK
• Paolo Bossi, Medical Oncologist in Head and Neck Cancer Department, University of Brescia, ASST-Spedali Civili, Brescia, Italy
• Bernadette Foran, ‎Consultant Clinical Oncologist and Honorary Senior Lecturer, ‎Weston Park Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
• Ricard Mesia, Medical Oncologist and Clinical and Research Program Leader in Head and Neck Cancer, Catalan Institute of Oncology, Hospital Llobregat, Barcelona, Spain
• Robert Metcalf, Honorary Consultant in Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK
• Anonymous KOL, Professor at a major university hospital, Germany

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