FDA lifts hold on Advaxis study of axalimogene filolisbac with durvalumab
Advaxis announced that the U.S. Food and Drug Administration,FDA has lifted the clinical hold on the company's Investigational New Drug application for its Phase 1/2 study of axalimogene filolisbac in combination with durvalumab for the treatment of patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer. The clinical hold for this study was issued on March 9, 2018 following submission by the Company of a safety report to the FDA regarding a patient death that occurred on February 27, 2018, post-dosing, involving acute respiratory failure after nine months of combination therapy. New guidelines for the early detection and treatment of such rare events were agreed to with the FDA and will be implemented for this combination study. Enrollment and dosing in all other Advaxis and durvalumab clinical programs were not affected by the clinical hold. "We are pleased to have resolved this issue with the FDA and will implement these guidelines across Advaxis' portfolio as needed, to ensure patient safety. We remain confident in the safety of axalimogene filolisbac based on our experience in treating approximately 400 patients and more than 1200 doses across multiple trials in HPV-associated cancers," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis.