![]() Of note, the cumulative cisplatin exposure of ≥200 mg/m 2 was comparable in both arms (>87 %).Įvent-free survival (EFS) – the primary endpoint – included death from any cause, progression according to RECIST v1.1 and pathologic proven relapse. In total, 210 patients (60 %) in the pembrolizumab arm and 223 (63 %) in the placebo arm completed the maintenance therapy at data cut-off. After a median follow-up of 47.7 months, 86 % of patients in the pembrolizumab plus CRT arm and 88 % in the placebo plus CRT arm completed concurrent CRT and had ongoing maintenance therapy. Human papillomavirus (HPV) was found in 27 % of patients in the pembrolizumab arm versus 26 % in the placebo arm. In both arms, most patients (around 85 %) showed a PD-L1 combined positive score (CPS) ≥ 1 and 36 % of them had CPS ≥ 20. Patients baseline characteristics were well balanced between both investigational groups. Stratification factors included radiotherapy regimen (accelerated fractionation versus standard fractionation ), tumor site/p16 status (oropharynx or larynx/hypopharynx/oral cavity) and disease stage (III versus IV). Pembrolizumab or placebo priming was given one week before CRT. Overall, 804 patients (ECOG PS 0-1) were randomized 1:1 to receive either pembrolizumab (200 mg, IV) + cisplatin 100 mg/m 2 every three weeks (Q3W) + CRT (70Gy/35F)) or placebo (Q3W) + CRT, followed by maintenance therapy with pembrolizumab or placebo for 14 cycles. ![]() At ESMO 2022, primary results of the KEYNOTE-412 trial were presented. The randomized, double-blind, phase III KEYNOTE-412 (NCT03040999) study investigated the efficacy and safety of pembrolizumab versus placebo given concomitantly with CRT, followed by maintenance therapy with pembrolizumab or placebo in treatment-naïve patients with unresected locally advanced HNSCC (defined as T3-T4 or any N2a-3 larynx/hypopharynx/oral cavity/p16 negative oropharynx cancers and T4 or N3 p16 positive oropharynx cancer). Food and Drug Administration (FDA) in June 2019 and by the European Medicines Agency (EMA) in November 2019 as first-line treatment for patients with metastatic or unresectable recurrent HNSCC either as monotherapy or in combination with platinum based chemotherapy. Pembrolizumab – a PD-1 immune checkpoint inhibitor – has been approved by the U.S. ![]() The current standard of care (SOC) for locally advanced unresectable HNSCC is concurrent chemoradiotherapy (CRT) with high-dose cisplatin. Around 90 % of head and neck cancers are HNSCC, with oral cavity, oropharynx, hypopharynx, and larynx being the most commonly affected areas. Head and neck squamous cell carcinoma (HNSCC) was the sixth most common cancer in 2018, with more than 700,000 newly diagnosed cases per year and 350,000 cancer deaths worldwide.
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