ISA Pharmaceuticals has randomised the first patient in a Phase II clinical trial investigating ISA101b in combination with cemiplimab (REGN2810) for the treatment of HPV16-positive oropharyngeal cancer (OPC).
ISA Pharmaceuticals’ lead compound ISA101b is a synthetic long peptide (SLP) immunotherapy targeting HPV16-induced diseases including cervical cancer and head–and-neck cancer, while cemiplimab is an anti-PD-1 antibody developed by Regeneron.
The double blind, placebo-controlled trial is expected to enroll around 164 patients who do not respond to first-line chemotherapy.
Patients will be randomly distributed in 1:1 ratio to receive a combination of either cemiplimab/ISA101b or cemiplimab/placeboin three-week cycles for up to 24 months.
The primary efficacy endpoint of the trial is to find out whether the combination of ISA101b and cemiplimab will obtain a higher overall response rate (ORR) over the combination of cemiplimab and placebo.
Secondary endpoints comprise progression-free survival (PFS), overall survival (OS), and safety and tolerability.
The trial will be carried out at around 50 sites across the US and Europe.
ISA Pharmaceuticals CMO Dr Leon Hooftman said: “ISA101b has already demonstrated very promising results when combined with nivolumab in a previous study in advanced HPV16-positive cancers.
“Particularly in patients with relapsed head-and-neck cancer, the percentage of patients with a meaningful tumour response appeared to be twice as high as achieved with nivolumab alone.
“The objective of the current randomised trial is to confirm such clinical benefit of ISA101b in a controlled setting.”