The HNSCC armamentarium is rapidly evolving. Where will IO move next?
BMS’ Opdivo and Merck & Co.’s Keytruda have transformed the second-line therapy of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and expectations are high that further approvals will continue to improve treatment outcomes. Could locoregional disease become the next frontier in the battle of the immune checkpoint inhibitors in HNSCC? BMS (Opdivo), Merck & Co. (Keytruda), AstraZeneca (durvalumab) and Merck Group/Pfizer (avelumab) are all invested in curative-intent settings which represent a significant commercial opportunity. Will the much touted IO-based combinations live up to their promise, particularly in the first-line recurrent/metastatic setting? Could PD-L1 axis inhibition be successfully partnered with Incyte’s epacadostat, AstraZeneca’s tremelimumab, BMS’ ipilimumab or chemotherapy? Meanwhile, how will Eli Lilly/Merck Group’s Erbitux secure its market presence and where could Tessa Therapeutics’ TT10 fit in?
Twelve US and EU KOLs offer candid insights on three marketed therapies and seven Phase III drugs, as well as early development programmes.
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- Could locally-advanced disease become the next battleground for the immune checkpoint inhibitors? With BMS, Merck & Co., AstraZeneca, Merck Group/Pfizer and Incyte all investing in this area, who could emerge victorious?
- Competition is set to intensify in the first-line recurrent/metastatic setting. How do KOLs rate the prospects for Keytruda, Opdivo and durvalumab in this setting and what factors could heighten their chance of success?
- IO-based combinations are seen as high-risk, but potentially high-reward. KOLs rate the feasibility of such treatment strategies against a backdrop of scarce data and high expectations.
- Immunotherapy has transformed the second-line treatment of recurrent/metastatic HNSCC. But how do Opdivo and Keytruda compare clinically and how do oncologists choose between them?
- 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?
- Incyte’s IDO inhibitor epacadostat is being trialled in a multitude of combinations and settings. How do KOLs rate the potential promise of each of these scenarios?B7
- The EXTREME regimen is firmly entrenched as the first-line standard of care for recurrent/metastatic HNSCC. But what opportunities and threats lie ahead for Erbitux?
- How do KOLs rate the potential for DNA repair inhibitors to constitute effective HNSCC therapies? Could AstraZeneca’s olaparib or Amgen’s AMG 319 play a role?
- The use of molecular biomarkers has not previously been instrumental in guiding treatment choices in HNSCC. Is this expected to change in the face of the rapid evolution of therapeutic options?
“This is going to be the next frontier in the battle between the immune checkpoint inhibitors. Whether one drug is better than the other in the locally advanced setting is really critical for HNSCC, even more than lung cancer, because the vast majority of patients are diagnosed in the locally advanced setting.” US Key Opinion Leader
“In the next five years I'm expecting the EXTREME regime not to be the first-line therapy anymore. I'm expecting it to be replaced by an immunotherapy of some sort, the race is on as to which one that will be.”US Key Opinion Leader
“There's pretty good evidence that any one checkpoint plus an IDO inhibitor has activity, probably with less toxicity than the CTLA-4 inhibitors like ipilimumab or tremelimumab. I think the IDO inhibitors, like epacadostat, are among the top immune therapies coming behind the PD-1/L1 checkpoint drugs.”US Key Opinion Leader
Sample of therapies covered
- Erbitux (cetuximab; Eli Lilly/Merck Group)
- Opdivo (nivolumab; Bristol-Myers Squibb)
- Keytruda (pembrolizumab; Merck & Co.)
- Durvalumab (Imfinzi; AstraZeneca)
- Avelumab (Bavencio; Merck Group/Pfizer)
- Epacadostat (INCB-24360; Incyte)
- TT10 (EBV-specific T-cells; Tessa Therapeutics)
- Multikine (Leukocyte interleukin, CEL-SCI)
- Afatinib (Gilotrif/Giotrif; Boehringer Ingelheim)
- Vinflunine(Javlor; Pierre Fabre)
- DNA damage repair inhibitors (e.g. Amgen’s AMG 319 and AstraZeneca’s olaparib [Lynparza])
- STAT3 transcription factor inhibitors (e.g. AstraZeneca/Ionis’ AZD9150) -
- HER3 receptor inhibitors (e.g. Amgen/Daiichi Sankyo’s patritumab)
KOLs from North America
- Bruce E. Brockstein, Division Head, Hematology/Oncology, Department of Medicine, Medical Director, Kellogg Cancer Center, Highland Park, IL.
- Saad Khan, Assistant Professor, Medical Oncologist, Southwestern Medical Center, University of Texas, Dallas, TX.
- Neal E. Ready, Professor of Medicine, Member of the Duke Cancer Institute, Duke University School of Medicine, Durham, NC.
- Rafael Santana-Davila, Medical Oncologist, The Seattle Cancer Center/Assistant Professor, University of Washington School of Medicine, Seattle, WA.
- Tanguy Seiwert, Assistant Professor of Medicine, University of Chicago Medicine, Chicago, IL.
- Jared Weiss, Associate Professor, University of North Carolina at Chapel Hill, Chapel Hill, NC.
- Caroline Brammer, Consultant in Clinical Oncology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
- Daris Ferrari, Director of medical oncology, University of Milan Hospital, Milan, 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.
- Stephane Temam, Head of Department of Head & Neck Cancer, Gustave Roussy Institute, Villejuif, France.
- Anonymous German KOL, Professor and chairman of the ENT department, a major university hospital, Germany.
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5.1 Marketed drugs
5.1.1 Erbitux (cetuximab; Eli Lilly/Merck Group)
5.2 Pipeline drugs
5.2.1 Afatinib (Gilotrif/Giotrif; Boehringer Ingelheim)
6.1 Marketed drugs
6.1.1 Key insights summary
6.1.2 Opdivo (nivolumab; Bristol-Myers Squibb)
6.1.3 Keytruda (pembrolizumab; Merck & Co.)
6.2 Pipeline drugs
6.2.1 Durvalumab (Imfinzi; AstraZeneca)
6.2.2 Avelumab (Bavencio; Merck Group/Pfizer)
6.2.3 Epacadostat (INCB-24360; Incyte)
6.2.4 TT10 (EBV-specific T-cells; Tessa Therapeutics)
6.2.5 Multikine (leukocyte interleukin; CEL-SCI)
7. Other 116
7.1 Pipeline drugs 116
7.1.1 Vinflunine (Javlor; Pierre Fabre)
8. Early-stage clinical programmes
8.1 Immunotherapy combinations
8.2 DNA damage repair inhibition
8.3 STAT transcription factor inhibition
8.4 HER3 receptor inhibition
10.1 KOL details
10.1.1 KOLs from North America
10.1.2 KOLs from Europe