![]() ![]() ![]() Patients were randomized 1:1:1 to receive 200 mg of pembrolizumab alone every 3 weeks for 2 years (n = 301), pembrolizumab plus platinum-based chemotherapy and 5-fluorouracil (5-FU n = 281), or the EXTREME regimen comprised of cetuximab at a loading dose of 400 mg/m 2 followed by a weekly dose of 250 mg/m 2, plus cisplatin at 100 mg/m 2 or carboplatin at area under the curve 5 given every 3 weeks, plus 5-FU at a daily dose of 1000 mg/m 2 on days 1 through 4 of each 3-week cycle for a maximum of 6 cycles (n = 300). ![]() Patients were stratified by PD-L1 expression, p16 status, and performance status. Patients enrolled to KEYNOTE-048 had recurrent and/or metastatic squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx who had a good ECOG performance status with tissue available for PD-L1 testing, and who had not received prior chemotherapy or systemic therapy for their recurrent or metastatic disease. Pembrolizumab plus chemotherapy also improved OS vs the control arm in patients with a PD-L1 CPS of 1 or higher, 20 or higher, and all patients.īased on these results, in June 2019, the FDA approved pembrolizumab alone or pembrolizumab plus chemotherapy for the frontline treatment of patients with HNSCC. 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 =. 10.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). Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part). Vermorken JB, Peyrade F, Krauss J, et al. Management of recurrent and metastatic oral cavity cancer: Raising the bar a step higher. Platinum-based chemotherapy plus cetuximab in head and neck cancer. 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. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. Ferris RL, Blumenschein G, Jr, Fayette J, et al. ![]()
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