The most common adverse reactions (20) were fatigue (33), constipation (20), and rash (20). Gr 3-5 TRAE rates (P+C vs E): 76% vs 90%. In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12 of 300 patients with HNSCC the most common adverse reactions leading to permanent discontinuation were sepsis (1.7) and pneumonia (1.3). Efficacy was assessed in participants with a programmed death ligand-1 (PD-L1) combined positive score (CPS) 20 and CPS 1 and the total population. KEYNOTE 048 PLUSPFS was longer (P+C vs E) in CPS≥20 (HR, 0.34 95% CI, 0.09-1.19), CPS≥1 (HR, 0.67 95% CI, 0.32-1.41), and total pop (HR, 0.74 95% CI, 0.38-1.42). KEYNOTE-048 investigated pembrolizumab monotherapy and pembrolizumab plus chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma. Gr 3-5 tx-related AE (TRAE) rates (P vs E): 22% vs 90%. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): A randomised, open-label, phase 3 study. Burtness B, Harrington KJ, Greil R, et al. Pembrolizumab alone or with chemotherapy for recurrent/metastatic head and neck squamous cell carcinoma in KEYNOTE-048: Subgroup analysis by programmed death ligand-1 combined positive score. KEYNOTE 048 FULLPlease see the original reference for a full list of disclosures.ġ. KEYNOTE 048 TRIALSome study authors declared affiliations with biotech, pharmaceutical, and/or device companies. The efficacy of KEYTRUDA was investigated in KEYNOTE-048, a randomized, multicenter, open-label, active-controlled trial conducted in 882 patients with metastatic HNSCC who had not previously received systemic therapy for metastatic disease or with recurrent disease who were considered incurable by local therapies. “Although PD-L1 expression is informative, exploration of additional predictive biomarkers is needed for low PD-L1-expressing HNSCC.”ĭisclosures: This research was supported by Merck Sharp & Dohme Corp. “Results from the PD-L1 CPS 1-19 subgroup support previous findings of treatment benefit with pembrolizumab monotherapy and pembrolizumab-chemotherapy in patients with PD-L1 CPS ≥1 tumors,” the researchers wrote. The median OS was 11.3 months in the pembrolizumab-chemotherapy group (n=39) and 10.7 months in the cetuximab-chemotherapy group (n=43 HR, 1.21 95% CI, 0.76-1.94 P =.78932). In the CPS below 1 cohort, the median OS was 7.9 months in the pembrolizumab-alone group (n=44) and 11.3 months in the cetuximab-chemotherapy group (n=45 HR, 1.51 95% CI, 0.96-2.37 P =.96241). In the cohort with CPS below 1, neither pembrolizumab nor pembrolizumab-chemotherapy improved OS compared with cetuximab-chemotherapy. The median OS was 12.7 months in the pembrolizumab-chemotherapy group (n=116) and 9.9 months in the cetuximab-chemotherapy group (n=125 HR, 0.71 95% CI, 0.54-0.94 P =.00726). In the CPS 1-19 cohort, the median OS was 10.8 months in the pembrolizumab group (n=124) and 10.1 months in the cetuximab-chemotherapy group (n=133 hazard ratio, 0.86 95% CI, 0.66-1.12 P =.12827). However, only patients treated with pembrolizumab-chemotherapy had superior OS compared with patients who received cetuximab-chemotherapy. In the CPS 1-19 subgroup, both pembrolizumab alone and pembrolizumab-chemotherapy demonstrated antitumor activity. 2įor the current analysis, researchers evaluated patients with a PD-L1 CPS below 1 (n=128) and those with a CPS of 1-19 (n=373). In a prior analysis, pembrolizumab monotherapy and pembrolizumab-chemotherapy significantly improved OS, compared with cetuximab-chemotherapy, in patients with a PD-L1 CPS of 20 or higher and in those with a CPS of 1 or higher. Patients were randomly assigned to receive pembrolizumab alone (n=301), pembrolizumab plus chemotherapy (platinum and fluorouracil n=281), or cetuximab plus chemotherapy (platinum and fluorouracil n=300). The KEYNOTE-048 trial ( Identifier: NCT02358031) enrolled 882 patients with recurrent or metastatic HNSCC.
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