Pembrolizumab versus methotrexate, docetaxel, or cetuximab in recurrent or metastatic head and neck squamous cell carcinoma (KEYNOTE-040): Subgroup analysis by pattern of disease recurrence.
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Embargo End Date
ICR Authors
Authors
Harrington, KJ
Cohen, EEW
Soulières, D
Dinis, J
Licitra, L
Ahn, M-J
Soria, A
Machiels, J-P
Mach, N
Mehra, R
Burtness, B
Swaby, RF
Lin, J
Ge, J
Lerman, N
Tourneau, CL
Cohen, EEW
Soulières, D
Dinis, J
Licitra, L
Ahn, M-J
Soria, A
Machiels, J-P
Mach, N
Mehra, R
Burtness, B
Swaby, RF
Lin, J
Ge, J
Lerman, N
Tourneau, CL
Document Type
Journal Article
Date
2023-12-01
Date Accepted
2023-10-06
Abstract
BACKGROUND: In the phase 3 KEYNOTE-040 study, pembrolizumab prolonged OS versus chemotherapy in previously treated recurrent or metastatic (R/M) HNSCC. We present a post hoc subgroup analysis by disease recurrence pattern: recurrent-only, recurrent and metastatic (recurrent-metastatic), and metastatic-only HNSCC. MATERIALS AND METHODS: Patients had HNSCC that progressed during or after platinum-containing treatment for R/M disease or had recurrence or progression within 3-6 months of previous platinum-containing definitive therapy for locally advanced disease. Patients were randomly assigned (1:1) to pembrolizumab 200 mg Q3W or investigator's choice of standards of care (SOC): methotrexate, docetaxel, or cetuximab. Outcomes included OS, PFS, ORR, and DOR. The data cutoff was May 15, 2017. RESULTS: There were 125 patients (pembrolizumab, 53; SOC, 72) in the recurrent-only subgroup, 204 in the recurrent-metastatic subgroup (pembrolizumab, 108; SOC, 96), and 166 in the metastatic-only subgroup (pembrolizumab, 86; SOC, 80). The hazard ratio (95% CI) for death for pembrolizumab versus SOC was 0.83 (0.55-1.25) in the recurrent-only, 0.78 (0.58-1.06) in the recurrent-metastatic, and 0.74 (0.52-1.05) in the metastatic-only subgroups. PFS was similar between treatment arms in all subgroups. ORR was 22.6% for pembrolizumab versus 16.7% for SOC in the recurrent-only, 10.2% versus 6.3% in the recurrent-metastatic, and 15.1% versus 8.8% in the metastatic-only subgroups. DOR was numerically longer with pembrolizumab in all subgroups. CONCLUSION: Pembrolizumab provided numerically longer OS and durable responses in all subgroups compared with SOC, suggesting that patients with previously treated R/M HNSCC benefit from pembrolizumab regardless of recurrence pattern.
Citation
Oral Oncology, 2023, 147 pp. 106587 -
Source Title
Oral Oncology
Publisher
ELSEVIER
ISSN
1368-8375
eISSN
1879-0593
1879-0593
1879-0593
Collections
Research Team
Targeted Therapy