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NICE Rejects Treatments for Head and Neck Cancer and AML

Kristi Rosa
Published: Wednesday, Jan 15, 2020

The United Kingdom’s National Institute for Health and Care Excellence (NICE) has issued guidelines recommending against pembrolizumab (Keytruda) for use in treatment-naïve patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 with a combined positive score (CPS) of ≥1.1 The agency also recommended against gilteritinib (Xospata) for patients with relapsed/refractory acute myeloid leukemia (AML) who harbor a FLT3 mutation.2

With regard to pembrolizumab as monotherapy and in combination with platinum-based chemotherapy and 5-fluorouracil (5-FU), the committee recommended that the agency request further clarification and analyses from Merck, the developer of the PD-1 inhibitor. The company should provide the following information, according to NICE:
  • A full comparison of baseline patient characteristics for 2 subgroups: those whose cancer started inside or outside of the oral cavity;
  • Overall survival (OS) data for the 2 subgroups and a formal statistical analysis to adjust for imbalances in baseline patient characteristics in the subgroups;
  • OS extrapolation curves, after adjusting for imbalances in baseline patient characteristics for the 2 subgroups;
  • An alternative utility value for progressive disease, based on published literature;
  • Examination of techniques to provide full incremental analyses for the 2 subgroups
    • Execute alternative analyses using data from the phase III KEYNOTE-048 trial to compare pembrolizumab with platinum chemotherapy and 5-FU. This information should be made available to NICE for the next appraisal meeting, according to the appraisal consultation document.
Data from the protocol-specified final analysis of the KEYNOTE-048 trial showed that the combination of pembrolizumab and chemotherapy resulted in a significant improvement in OS compared with the standard EXTREME regimen, comprised of cetuximab (Erbitux) plus either carboplatin or cisplatin and 5-FU in patients with a CPS of ≥20 (HR, 0.60; 95% CI, 0.45-0.82; P =.0004) and those with a CPS of ≥1 (HR, 0.65; 95% CI, 0.53-0.80; P <.0001).3
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