NEW YORK – Commercial lab company OmniSeq on Thursday announced that it is collaborating with the University of Pittsburgh Medical Center (UPMC) on a Phase II clinical trial of immunotherapy in head and neck cancer.
The trial will use OmniSeq's immune profiling RNA-seq gene expression assay to determine whether roughly 40 patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) should be treated with either nivolumab (Bristol Myers Squibb's Opdivo) plus ipilimumab (BMS' Yervoy) or nivolumab plus relatlimab, BMS' investigational anti-LAG3 monoclonal antibody.
The trial will assess whether patients respond to the immunotherapy combination when the specific drugs are selected based on immune gene expression, as characterized by OmniSeq's assay. To evaluate this, the trial is designed with probability of objective response as its primary outcome. Secondary outcomes include disease control rate, progression-free survival, overall survival, and adverse events.
All patients with HNSCC enrolled on the trial will have experienced disease progression after treatment with an anti-PD-1 or anti-PD-L1 monoclonal antibody. Upon trial enrollment, tumor tissue samples will be collected from these patients for immune gene expression profiling.
"OmniSeq is pleased that our RNA-seq gene expression assay will be leveraged in [principal investigator Daniel Zandberg's] Phase II trial for patient stratification," Jeffrey Conroy, OmniSeq's chief scientific officer, said in a statement. "Our RNA-seq platform allows data-driven matching of HNSCC patients to the appropriate investigational combination therapy based on the immunological tumor landscape."