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Head and Neck Squamous Cell Carcinoma (HNSCC): Update Bulletin #2 [September 2018]

Product Code:
Publication Date:
September 2018

Gain new KOL insights on the latest events happening in head and neck squamous cell carcinoma (HNSCC), including:  the European Medicines Agency's (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommendation that Keytruda (pembrolizumab; Merck & Co.) be approved as a monotherapy to treat recurrent or metastatic HNSCC; Merck & Co.’s announcement that the Phase III KEYNOTE-048 trial of Keytruda for the first-line treatment of recurrent or metastatic HNSCC met its co-primary endpoint of overall survival (OS) in patients whose tumours expressed PD-L1; an interim analysis from the Phase III RTOG-1016 trial of patients with HPV (human papillomavirus)-positive oropharyngeal cancer reporting that treatment with radiation therapy and Erbitux was associated with worse OS and progression-free survival (PFS), compared with radiation and cisplatin.

Business Questions:

• What are the immediate reactions among KOLs to the EU recommendation that Keytruda be approved as a monotherapy in the treatment of recurrent or metastatic HNSCC?
• How do KOLs view the recommended restriction in the use of Keytruda in the EU to patients whose tumours express high levels PD-L1?
• How do KOLs view the efficacy of Keytruda compared with Opdivo, and how do oncologists choose between these PD-1 inhibitors in the treatment of HNSCC?
• How is the positive OS outcome from KEYNOTE-048 perceived and could it form the basis for a successful first-line regulatory approval of Keytruda?
• Are KOLs concerned by the failure of Keytruda to extend PFS at the interim analysis of the KEYNOTE-048 trial?
• If Keytruda gains approval for the first-line treatment of HNSCC, to what extent is it likely to be used in this setting?
• How do KOLs interpret the outcome from the RTOG-1016 trial of Erbitux plus radiotherapy in HPV-positive oropharyngeal cancer, and how could these findings impact treatment practice?


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