On March 1, 2022 ISA reported the publication of extension data from a key study using lead product ISA101b in the Journal of ImmunoTherapy of Cancer (Press release, ISA Pharmaceuticals, MAR 1, 2022, View Source [SID1234609264]). The study, ISA101 and nivolumab for HPV-16+ cancer: updated clinical efficacy and immune correlates of response, is performed by Guimaraes Sousa, Michael Curran, Bonnie Glisson et al. in collaboration with the MD Anderson Cancer Center in Houston, Texas .
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The initial study by Massarelli et al. was published in 2018*. It investigated ISA101b in combination with anti-PD1 checkpoint inhibitor nivolumab (OPDIVO) in head-and-neck cancer. In this open-label study, 22 patients with recurrent/metastatic Human Papilloma Virus type 16-positive (HPV16+) OroPharyngeal Cancer (OPC) were treated. The Objective Response Rate (ORR) in this difficult to treat patient population was 36%, with a median Overall Survival (mOS) of 17.,5 months.
Two patients in the first study displayed a Complete Response to treatment. This follow-up study shows they survived disease-free for more than 44 months.
Prof. Dr. Cornelis Melief, Chief Scientific Officer of ISA Pharmaceuticals, said: "We are delighted to see the results of this key study published as we continue to develop an exciting pipeline of cancer vaccines. Our work shows that a combination of ISA101b and anti-PD-1 remains a promising treatment vastly improving patient prognosis and long-term responses."
ISA’s product portfolio consists of multiple synthetic long peptide (SLP) therapeutics for cancer and infectious diseases. The SLP approach is designed to unleash a durable and broad T cell immune response to specific diseases. It enables a patient’s own immune system to attack and destroy tumour cells or viruses for significant clinical benefit. ISA101b is based on this technology and is currently being studied in HPV16+ cancers in combination with Libtayo (cemiplimab) in three phase 2 clinical trials under a strategic collaboration with Regeneron. Libtayo is an anti-PD-1 antibody that is being jointly developed by Regeneron and Sanofi.
*Massarelli et al, JAMA Oncology 2018