Association of Low and Intermediate Combined Positive Scores With Outcomes of Treatment With Pembrolizumab in Patients With Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma: Secondary Analysis of Keynote 048
Mené sur des patients atteints d'un carcinome épidermoïde de la tête et du cou récidivant et métastatique, cet essai évalue l'efficacité, du point de vue de la survie globale, du pembrolizumab, dispensé seul ou en combinaison avec une chimiothérapie, en fonction d'un score positif combiné (CPS) mesurant le niveau d'expression du PD-L1
Keynote 048 (NCT02358031) established the benefit of treatment with pembrolizumab monotherapy (pembro-mono) and pembrolizumab plus chemotherapy (pembro-chemo) for recurrent and metastatic head and neck squamous cell carcinoma (RM HNSCC). Patients were randomized (1:1:1) to receive treatment with pembro-mono, pembro-chemo, or cetuximab with chemotherapy (cetux-chemo), and were stratified by the combined positive score (CPS), a measure of programmed cell death–ligand 1 staining. The authors reported overall survival (OS) analyses for the total population, those with a CPS of 20 or greater, and those with a CPS of 1 or greater, but to our knowledge, data on outcomes for patients with an intermediate (1-19) or low (<1) CPS have not been previously published. Because the response to treatment with pembrolizumab is associated with CPS in RM HNSCC, there is concern that the clinical outcomes for those in the pembrolizumab-containing arms may be attenuated or reversed in the intermediate and low CPS groups. Combined, these subsets represented 57% of the Keynote 048 study population.