On May 28, 2024 ISA reported 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 (Free ASCO Whitepaper) annual conference (Press release, ISA Pharmaceuticals, MAY 28, 2024, View Source [SID1234643736]). 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.
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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 1st or 2nd 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).
Presentation Title: Results of a randomized, double-blind, placebo-controlled, phase 2 study (OpcemISA) of the combination of ISA101b and cemiplimab versus cemiplimab for recurrent/metastatic (R/M) HPV16-positive oropharyngeal cancer (OPC)
Presentation Time: Tuesday June 4th, 2024, 09:45 CDT
Presenting Author: Dr. Caroline Even, Principal Investigator
Session (oral): Head and Neck Cancer
Abstract #: 6003
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.
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