FDA gives ISA101b fast track designation for HPV 16+ oropharyngeal cancer
Source: www.cancernetwork.com Author: Hayley Virgil The first patients with human papillomavirus 16–positive oropharyngeal cancer have been dosed with ISA101b, which was given a fast track designation by the FDA, as part of a phase 2 study. ISA101b has received a fast track designation from the FDA for the treatment of patients with recurrent and metastatic human papillomavirus (HPV) 16–positive oropharyngeal cancer, according to a press release from drug developer ISA Pharmaceuticals.1 The fast track designation is intended to facilitate the development of investigational therapies that may help to address unmet medical needs for serious or life threatening diseases. An ongoing randomized, double-blind phase 2 trial is examining cemiplimab (Libtayo) with or without ISA101b and has an estimated enrollment of 194 patients (NCT03669718). “Recurrent and metastatic HPV16-positive OPC is a form of head and neck cancer with a high unmet medical need. The Fast Track designation for ISA101b underlines the potential benefit of this immunotherapy for patients suffering from this disease,” Leon Hooftman, chief medical officer at ISA Pharmaceuticals, said in a press release. ISA101b elicits strong and specific immune responses to HPV16 virus proteins and creates a robust T-cell immune response against cancerous cells or tissues. In the ongoing trial, patients in the experimental arm will receive ISA101b 3 times over 3 weeks plus cemiplimab every 3 weeks for up to 24 months, and the control arm will receive a matched placebo plus cemiplimab at the same dose. The primary outcome measures are overall response rate and safety, with a [...]