OmniSeq is partnering with the University of Pittsburgh Medical Center to employ a gene expression assay investigating the potential for personalized immunotherapy combinations for patients with head and neck squamous cell carcinoma.
OmniSeq and the University of Pittsburgh Medical Center (UPMC) are partnering ahead of a phase 2 clinical trial (NCT04326257) examining patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), according to a press release.
OmniSeq will employ its RNA sequencing gene expression profile assay for the selection of immunotherapy combinations for patients with this disease type enrolled in the trial’s population.
By employing a more personalized approach for the selection of novel immunotherapeutic combinations moving forward, response rates should improve and better predictive biomarkers of efficacy should develop further.
“We are excited for this collaboration and to be able to offer the gene expression profile technology to [patients with recurrent/metastatic HNSCC] who have failed prior immunotherapy,” principal investigator and co-leader of the Head & Neck Program at UPMC Hillman Cancer Center, Dan Zandberg, MD, explained in a press release. “This trial represents an important first step towards taking a personalized approach to each patient to determine the best combination immunotherapy regimen to use.”
To be eligible, patients will have tumor tissue by core or excisional/incisional biopsy for gene expression of LAG3 and CTLA4 via RNA sequencing to determine the best course of treatment between relatlimab or ipilimumab to add to nivolumab.
As long as minimum difference requirements for the patient are met, the drug selection to add to nivolumab will be based on the highest expression of relevant genes. If minimum difference requirements are not met, the patients will be randomized to either relatlimab or ipilimumab (Yervoy) plus nivolumab (Opdivo). Patients will undergo their particular therapy for up to 24 cycles.
The primary end point of the phase 2 study is the probability of objective response to therapy, with secondary end points of disease control rate, progression-free survival, overall survival, and adverse events.
The open-label, parallel arm trial is expected to enroll 40 patients for randomization in the 2 treatment types, with an estimated primary completion date of March 2022 and estimated study completion date of March 2023.
“OmniSeq is pleased that our [RNA sequencing] gene expression assay will be leveraged in Dr. Zandberg’s Phase 2 trial for patient stratification,” Jeffrey Conroy, OmniSeq's chief scientific officer, said in a press release. “Our [RNA sequencing] platform allows data-driven matching of HNSCC patients to the appropriate investigational combination therapy based on the immunological tumor landscape.”
OmniSeq’s comprehensive immune profiling assay is designed to measure both known and novel immune biomarkers in solid tumor tissue at the same time to inform correlative studies, drug development, and combination immunotherapy trials.
OmniSeq and UPMC Collaborate to Launch Novel Phase II Prospective Head and Neck Cancer Clinical Study [news release]. Buffalo, New York. Published January 28, 2021. https://www.prnewswire.com/news-releases/omniseq-and-upmc-collaborate-to-launch-novel-phase-ii-prospective-head-and-neck-cancer-clinical-study-301217239.html. Accessed January 29, 2021.