KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC.
From Lancet, Burtness B, Harrington KJ, Greil R, et al; for the KEYNOTE-048 investigators. 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. Lancet. 2019;394(10212):1915–1928.
aPatients with M/uR HNSCC had not previously received systemic therapy for metastatic disease or had recurrent disease and were considered incurable by local therapies.
bEXTREME = cetuximab + platinum + fluorouracil.
- MEDIAN OS WAS 12.3 MONTHS WITH KEYTRUDA vs 10.3 months with EXTREME.
- 22% reduction in the risk of death with KEYTRUDA vs EXTREME (HR=0.78; 95% CI, 0.64–0.96; P=0.0171).
- Number of events: 177 (69%) with KEYTRUDA vs 206 (81%) with EXTREME
- Median PFS was 3.2 months (95% CI, 2.2–3.4) with KEYTRUDA vs 5.0 months (95% CI, 4.8–5.8) with EXTREME (HR=1.15; 95% CI, 0.95–1.38).
1L = first line; CI = confidence interval; HR = hazard ratio; PD-L1 = programmed death ligand 1; PFS = progression-free survival; plat/FU = platinum + fluorouracil.
From Lancet, Burtness B, Harrington KJ, Greil R, et al; for the KEYNOTE-048 investigators. 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. Lancet. 2019;394(10212):1915–1928.
- 2-YEAR OS RATE WAS 29% WITH KEYTRUDA vs 17% with EXTREME.2
- The protocol-specified final analysis occurred after the interim analysis, which demonstrated the superiority of KEYTRUDA monotherapy (CPS ≥1) in overall survival compared to EXTREME. The interim analysis was the definitive study finding for overall survival with KEYTRUDA monotherapy (CPS ≥1).1
cMedian follow-up time of 11.5 months at the protocol-specified final analysis.1
ORR = objective response rate; CR = complete response; PR = partial response; DOR = duration of response.
- Three-arm trial compared KEYTRUDA as monotherapy or in combination with plat/FU vs EXTREME in the first-line setting for metastatic or unresectable, recurrent HNSCC.
- Main efficacy outcome measures were OS and PFS (assessed by BICR according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ).
- Efficacy was evaluated sequentially in the CPS ≥20 study population, CPS ≥1 study population, and the overall population.
AUC = area under the curve; BICR = blinded independent central review; ECOG PS = Eastern Cooperative Oncology Group performance status; Q1W = every week; Q3W = every 3 weeks; RECIST v1.1 = Response Evaluation Criteria In Solid Tumors v1.1; R/M = recurrent or metastatic; TPS = tumor proportion score.