• Dr. Caroline Even (Institut Gustave Roussy, Paris), Principal Investigator, will present results from OpcemISA, a randomized, placebo controlled clinical trial in advanced head-and-neck cancer
• Data from a state of the art double blind placebo controlled phase 2 trial in 199 patients with advanced HPV16 induced head and neck cancer give direction as to which patients are true candidates for ISA101b, to be confirmed in phase 3

Oegstgeest, 28 May 2024 – ISA today announces that Dr Caroline Even, oncologist at Institut Gustave Roussy, will present the results of the double blind OpcemISA clinical trial with 199 patients at the ASCO annual conference. The study evaluates the addition of the Human Papilloma Virus type 16 (HPV16) directed cancer vaccine ISA101b to an anti-PD-1 checkpoint inhibitor (CPI) in patients with recurrent metastatic HPV16 induced head and neck cancers.

This trial is the first to have generated randomized, placebo-controlled data of the contribution of a cancer vaccine in this indication. The results of this study offer unique biomarker-defined insights as regards patient selection, thereby substantially derisking future clinical development of ISA101b.

Patients with 1^st or 2^nd line recurrent and/or metastatic HPV16 positive oropharyngeal cancer (OPC) were treated with CPI plus ISA101b or placebo until disease progression or withdrawal. Further information about the study design can be found on clinicaltrials.gov (NCT03669718).

Head-and-neck cancer is one of the most aggressive and life-threatening malignancies. HPV16 is fast becoming the predominant cause of head-and-neck cancer. Recurrent and metastatic HPV16 positive OPC is a form of head-and-neck cancer with a high unmet medical need that may be susceptible to this form of combined immunotherapy. In September 2021 ISA101b was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent and metastatic HPV16 positive OPC.

For more information, please contact us at info@isa-pharma.com.