Significance of the All-Comer PD-L1 CPS Design

Paul L. Swiecicki, MD, of the University of Michigan Rogel Cancer Center, explains the significance of OrigAMI-5's all-comer design, which enrolls patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) regardless of PD-L1 combined positive score (CPS), using local CPS testing only for stratification rather than eligibility. He contrasts this with other EGFR bispecific-plus-pembrolizumab trials in HPV-negative HNSCC, which are restricted to patients with a CPS of 1 or higher, reflecting pembrolizumab's approved indication. Dr Swiecicki notes that CPS will still be evaluated post hoc as part of the statistical design, but that the all-comer approach captures the roughly 20% of community patients with a CPS of 0, a subgroup he describes as an unmet need since current chemoimmunotherapy options are suboptimal for them and other phase 3 trial designs are not targeting this population.