The Keynote-412 trial displays statistically insignificant results for Pembrolizumab plus CRT in locally advanced head and neck squamous cell carcinoma

Keynote-412 trial failure a setback for locally advanced patients in HNSCC

Sep 12, 2022 | DelveInsight

KEYTRUDA (Pembrolizumab) is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. With very limited treatment options available to treat HNC, recently, the first-line therapy for recurrent/metastatic (R/M)-HNSCC has been revolutionized by introducing Pembrolizumab. The drug was being investigated in a trial where newly diagnosed, pathologically proven, treatment-naive LA-HNSCC (T3–T4 [N0–N3] or any N2a–3 [T1–T4] larynx/hypopharynx/oral cavity/p16-negative oropharynx cancers and T4 or N3 p16-positive oropharynx cancer) who were eligible for definitive CRT were randomized.

For CPS ≥1, the 24-month EFS rate was 63.7% for pembro + CRT vs 56.3% for the placebo arm and the 36-month OS rate was observed as 71.4% vs 70.2%. For CPS ≥20, the 24-month EFS rate was 71.2% vs 62.6% and the 36-month OS rate was found to be 79.1% vs 73% the for pembro + CRT arm and the placebo arm respectively.

Pembrolizumab plus CRT was associated with a favorable trend towards improved EFS vs placebo plus CRT in patients with LA HNSCC. Although, the difference in the EFS of the two arms was not statistically significant. No new safety signals were seen. The results from the study indicate that PD-L1 expression may be an informative predictive biomarker.

KOL insights

“There have been limited advances for patients with locally advanced HNSCC and unfortunately, these results suggest that this disease remains very challenging to treat,” “It seems that the drug could benefit the PD-L1 expressing tumors and it was able to reduce the risk of progression or death by 20% over chemoradiation alone.”-Expert Opinion

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