Patient Death Forces FDA to Put Hold on AstraZeneca Cancer Drug Trial
The Federal regulator agency has now imposed a hold upon a clinical trial testing a combination of Advaxis’ axalimogene filolisbac and AstraZeneca’s Imfinzi after a patient died from respiratory failure.
The company says it, along with its partner, will work closely with the FDA to investigate the event and resolve the clinical hold.
The Listeria-based immunotherapy was being trialled as a treatment for advanced, recurrent or refractory human papillomavirus (HPV) associated cervical cancer and HPV-associated head and neck cancer. The respiratory failure occurred following the sixth combination cycle in the trial. It is now being investigated as a Grade 5 Serious Adverse Event.
The drug uses live attenuated Listeria monocytogenes (Lm) bioengineered to produce and deliver tumor antigen/adjuvant fusion proteins within antigen presenting cells with the goal of generating strong, T-cell-mediated immunity. It is being combined with AstraZeneca’s approved PD-1 inhibitor Imfinzi. The AstraZeneca drug has been approved by the FDA for non-small cell lung cancer patients who cannot have their tumors surgically removed, as well as some bladder cancers.
“It should be noted that over 250 patients have received axal and approximately 700 doses have been delivered across multiple trials in HPV-associated cancers to-date, and that this is the first time we have seen this type of event,
” said Advaxis interim CEO Tony Lombardo.AstraZeneca‘s Imfinzi (durvalumab) “has seen some other problems as well, but this is an atypical presentation for what they are used to seeing as well,” added Advaxis CSO Robert Petit. “We are still trying to get to the bottom.”
The clinical hold has no effect on enrollment and dosing in any of Advaxis’ other clinical programs, the company added.
“We are confident in the safety and efficacy profile of axalimogene filolisbac to date,” Lombardo said in a company statement. “We care deeply for our patients and for their safety as we work to research and develop new treatment options for advanced cancers. We believe in the potential of our Lm technology to provide new advancements in the area of cancer care.”
