KEYTRUDA® (pembrolizumab) in first-line head & neck squamous cell carcinoma (HNSCC)
Prescribing Information (Great Britain) &
Prescribing Information (Northern Ireland) [External links]
KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic or unresectable recurrent (M/uR) HNSCC in adults whose tumours express PD-L1 with a CPS ≥ 1.1
KEYTRUDA monotherapy for your M/uR HNSCC patients with PD-L1 expression of CPS ≥ 1
With KEYTRUDA monotherapy in the KEYNOTE-048 trial…
More than 1 in 4 patients were alive at 2 years1,2
PFS was not significantly different vs EXTREME3
There was a sustained response, with a median duration of 2 years2
The overall safety profile was favourable vs EXTREME, with the exception of hypothyroidism and pneumonitis1,2
Click on each tab below to explore data from the KEYNOTE-048 final analysis and 4-year post-hoc analysis:
Multi-centre, randomised, open-label, active-controlled Phase III study
A further 28% of patients in the KEYTRUDA monotherapy arm and 33% of patients in the EXTREME arm had stable disease.2
Post-hoc analyses were not powered for statistical comparison
Post-hoc analyses were not powered for statistical comparison
Post-hoc analyses were not powered for statistical comparison
*As-treated population = all patients who received at least one dose of allocated treatment.5
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Discover all the data for KEYTRUDA monotherapy in M/uR HNSCC
KEYTRUDA alone or in combination with chemotherapy
Both doses are administered as IV infusions over 30 minutes
CPS ≥ 1 in the KEYNOTE-048 study1
85%
(n=754/882) of treatment-naïve patients with M/uR HNSCC had tumours that expressed PD-L1 (CPS ≥ 1)3,6
KEYNOTE-048 trial was a multi-centre, randomised, open-label, active-controlled Phase III study.
KEYTRUDA monotherapy; EXTREME n=255.
Abbreviations
5-FU, 5-fluorouracil; AE, adverse event; AEOSI, adverse events of special interest; AUC 5, desired carboplatin exposure of 5 mg/ml; CI, confidence interval; CPS, combined positive score; CR, complete response; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; ESMO, European Society for Medical Oncology; EXTREME, cetuximab + 5-fluorouracil + platinum-based chemotherapy; HNSCC, head and neck squamous cell carcinoma; HR, hazard ratio; IHC, immunohistochemistry; ITT, intention to treat; IV, intravenous; mo, month; M/uR, metastatic or unresectable recurrent; No., number; NR, not reported; ORR, objective response rate; OS, overall survival; P16, cyclin-dependent kinase inhibitor 2A; PD, progressive disease; PD-1, programmed cell death-1; PD-L1, programmed death ligand-1; PFS, progression-free survival; PFS2, time from randomisation to objective tumour progression on next-line treatment or death from any cause; PR, partial response; Q1W, every week; Q3W, every 3 weeks; Q6W, every 6 weeks; QoL, quality of life; R, randomised; RECIST, Response Evaluation Criteria in Solid Tumours; SCC, squamous cell carcinoma; TPS, tumour proportion score; TRAE, treatment-related adverse events.
References
- KEYTRUDA (pembrolizumab) Summary of Product Characteristics.
- Burtness B et al. Lancet 2019:394;1915–28 (suppl. appx.).
- Burtness B et al. Lancet 2019:394;1915–28.
- Harrington K et al. Presented at American Society of Clinical Oncology (ASCO) Annual Meeting 2020. 29 May–2 June 2020.
- Greil R et al. Presented at ESMO Virtual Congress 2020; 19–21 September 2020.
- Agilent. PD-L1 IHC 22C3 pharmDx Interpretation Manual – HNSCC
GB-OHN-00357 | Date of Preparation: November 2021