Prior data from KEYNOTE-048 showed that pembrolizumab alone significantly improved OS compared with cetuximab plus chemotherapy in the subsets of patients with a PD-L1 CPS of 20 or higher and a CPS of 1 or higher, and noninferior OS in the total population. 008) in those with as PD-L1 CPS of 1 or higher vs a CPS of less than 1. 023) and a longer median OS (10 months vs 5 months P =. Results from the phase 1b KEYNOTE-012 trial (NCT01848834) demonstrated that pembrolizumab alone produced a higher overall response rate (21% vs 6% P =. PD-L1 is commonly expressed in HNSCC, although some tumors have low or undetectable levels. “These results suggest that PD-L1 expression may be useful in informing treatment decisions for some subgroups however, additional biomarkers are needed to further select patients who will benefit from PD-1 inhibition.” “Although these results should be interpreted cautiously given the post-hoc nature of the analysis and the small PD-L1 CPS <1 subgroup, they remain consistent with the FDA approval of pembrolizumab as monotherapy for first-line treatment of patients with relapsed or metastatic HNSCC with PD-L1 CPS ≥ 1 and of pembrolizumab plus chemotherapy for first-line treatment irrespective of PD-L1 status,” lead study Barbara Burtness, MD, professor of medicine (Medical Oncology) at Yale School of Medicine, and colleagues, wrote. In this subgroup, pembrolizumab plus chemotherapy (n = 39) resulted in a median OS of 11.3 months vs 10.7 months with cetuximab/chemotherapy (n = 43 HR, 1.21 95% CI, 0.76-1.94 P =. 00726).Ĭonversely, in patients with a PD-L1 CPS of less than 1, pembrolizumab monotherapy (n = 44) resulted in a median OS of 7.9 months (95% CI, 4.7-13.6) vs 11.3 months (95% CI, 9.1-15.9) with cetuximab plus chemotherapy (n = 45 HR, 1.51 95% CI, 0.96-2.37 P =. The addition of pembrolizumab to chemotherapy (n = 116) produced a median OS of 12.7 months (95% CI, 9.4-15.3) vs 9.9 months (95% CI, 8.6-11.5) with cetuximab plus chemotherapy (n = 125) in this subgroup (HR, 0.71 95% CI, 0.54-0.94 P =. Results, which were published in the Journal of Clinical Oncology, showed that in the PD-L1 CPS 1-19 subset, pembrolizumab monotherapy (n = 124) resulted in a median OS of 10.8 months (95% CI, 9.0-12.6) compared with 10.1 months (95% CI, 8.7-12.1) with cetuximab plus chemotherapy (n = 133 HR, 0.86 95% CI, 0.66-1.12 P =. Pembrolizumab (Keytruda) with or without chemotherapy resulted in a numerically longer overall survival (OS) benefit vs cetuximab (Erbitux) plus chemotherapy in patients with head and neck squamous cell carcinoma (HNSCC) and a PD-L1 combined positive score (CPS) between 1 and 19, but did not improve survival in the subset with a PD-L1 CPS of less than 1, according to data from a subgroup analysis of the phase 3 KEYNOTE-048 trial (NCT02358031).
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