Patients enrolled in the study were given the vaccine alongside Regeneron’s Libtayo (cemiplimab), an anti-PD1 checkpoint inhibitor. Credit: Shutterstock / steph photographies.

Immunotherapy firm ISA Pharmaceuticals has said that a Phase II trial investigating its therapeutic cancer vaccine ISA101b in oropharyngeal cancer (OPC) shows a clear route to market despite not meeting its primary endpoint.

The Netherlands-based biotechnology company has announced topline results from its ongoing Phase II OpcemISA trial examining its vaccine aimed at targeting cancers caused by the human papillomavirus type 16 (HPV16).

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The large-scale, randomised, double-blind study (NCT03669718) did not meet its primary endpoint of a six-month overall response rate (ORR) in the entire trial population. However, a predefined subgroup of patients demonstrated a doubling of ORR, with ISA101b-treated patients achieving an ORR of 51.9% compared to an ORR of 26.7% in the placebo group.

Patients enrolled in the study were given the vaccine alongside Regeneron’s Libtayo (cemiplimab), an anti-PD1 checkpoint inhibitor.

ISA CEO Gerben Moolhuizen said: “Recurrent and metastatic head and neck cancer is notoriously difficult to treat. Patients suffering from this terrible disease need new treatment options. In our OpcemISA study, ISA101b shows compelling results in a large, predefined subset of patients. This provides us with a clear development path to make ISA101b a treatment option for these patients.”

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The trial enrolled 199 first-line and second-line patients with recurrent or metastatic OPC and positive HPV16 status. The secondary endpoints included drug safety, progression-free survival and overall survival.

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Alongside the data announcement, ISA Pharmaceuticals said it is preparing for a confirmatory Phase III trial in the subpopulation of patients who saw an increase in their ORR.

GlobalData’s Pharmaceutical Intelligence Centre details how ISA101b is entering into a disease space that has seen as many as 203 treatments make it to market, with a further 20 in Phase III trials and 252 treatments currently in Phase II. It is estimated that the head and neck cancer market size in the US is worth an estimated $927m in 2023, with that figure expected to grow to $2.34bn by 2030.

GlobalData is the parent company of Clinical Trials Arena.

In September 2021, ISA101b was granted fast track designation by the US Food and Drug Administration for the treatment of recurrent and metastatic HPV16-positive oropharyngeal cancer.