KEYNOTE-048: Pembrolizumab Monotherapy in Head and Neck Squamous Cell Carcinoma

The phase III KEYNOTE-048 trial, which is investigating pembrolizumab (Keytruda) for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), met a primary endpoint of overall survival (OS) as monotherapy in patients whose tumors expressed programmed cell death ligand 1 (PD-L1, combined proportion score [CPS] ≥ 20). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), treatment with pembrolizumab monotherapy in these patients resulted in significantly longer OS compared to cetuximab (Erbitux) in combination with platinum chemotherapy (cisplatin or carboplatin) plus fluorouracil (5-FU), the current standard of care for HNSCC in the first-line treatment setting. At the time of the interim analysis, the dual-primary endpoint of progression-free-survival (PFS) for patients whose tumors expressed PD-L1 (CPS ≥ 20) had not been reached. The safety profile of pembrolizumab in this trial was consistent with that observed in previously reported studies involving patients with HNSCC. These results will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide.

Based on the recommendation of the DMC, the trial will continue with no changes to evaluate pembrolizumab monotherapy and pembrolizumab in combination with platinum chemotherapy plus 5-FU.

More About KEYNOTE-048

KEYNOTE-048 is a phase III, randomized, open-label trial designed to investigate pembrolizumab in the first-line setting as monotherapy or in combination with a platinum chemotherapy plus 5-FU compared to cetuximab with platinum chemotherapy plus 5-FU. The dual primary endpoints were OS and progression-free survival (PFS). The secondary endpoints of the study were PFS (at 6 months and 12 months), objective response rate (ORR), and time to deterioration in Quality of Life Global Health Status/Quality of Life Scales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire.

The estimated study enrollment is 825 patients who were randomly assigned to receive pembrolizumab as monotherapy (200 mg intravenously [IV] on day 1 of each week in 3-week cycles for up to 24 months), or:

  • Pembrolizumab 200 mg IV on day 1 of each week in 3-week cycles for up to 24 months, plus cisplatin 100 mg/m2 IV or carboplatin AUC 5 IV (investigator's choice) on day 1 of each week in 3-week cycles (six cycle maximum); plus 5-FU 1,000 mg/m2/d IV continuous from day 1–4 of each 3-week cycle (six cycle maximum); or
  • Cetuximab on day 1 at a dose of 400 mg/m2 IV, and then 250 mg/m2 IV on day 1 of each week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m2 IV or carboplatin AUC 5 IV (investigator's choice) on day 1 of each week in 3-week cycles (six cycle maximum for platinum-based therapy); plus 5-FU 1,000 mg/m2/d IV continuous from day 1–4 of each 3-week cycle (six cycle maximum).

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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