US regulators have placed on hold a clinical trial testing a combination of Advaxis’ axalimogene filolisbac and AstraZeneca’s Imfinzi after a patient died from respiratory failure.
The Phase I/II study is assessing the combination in patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.
The regulator suspended the trial on the back of a safety report on the death, which is referred to as a Grade 5 Serious Adverse Event and occurred following the sixth combination cycle in the trial.
As such, enrollment and further dosing are on hold in this trial while the company, its partner and the FDA work closely with the site investigator to review this event in detail and to resolve this clinical hold.
However, Anthony Lombardo, Advaxis’ interim chief executive, said the firm remains “confident in the safety and efficacy profile of axalimogene filolisbac, to date, based on our experience in over 250 patients and over 700 doses across multiple trials in HPV-associated cancers.”
Advaxis and AZ signed a deal in 2014 to their respective cancer immunotherapies in combination.
Imfinzi (durvalumab) is a PD-L1 checkpoint inhibitor that blocks a signal that helps tumours avoid detection, while axalimogene filolisba enhances the ability of immune cells to combat the tumour.
