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.