FDA News

FDA places clinical hold on trial of axalimogene filolisbac and durvalumab after patient death

The FDA placed a clinical hold on a phase 1/phase 2 clinical trial designed to evaluate the combination of axalimogene filolisbac plus durvalumab for the treatment of HPV-associated cervical or head and neck cancers, according to one of the agent’s manufacturers.

The FDA implemented the clinical hold after receiving a safety report that indicated a patient in the trial died after experiencing respiratory failure after the sixth cycle of treatment in the trial.

Researchers were studying axalimogene filolisbac (Axal, Advaxis) — a Listeria monocytogenes-based immunotherapy — in combination with the PD-L1 inhibitor durvalumab (Imfinzi, AstraZeneca), for the treatment of recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.

Patient enrollment and further dosing will remain on hold while the patient’s death is investigated.

“We care deeply for our patients and for their safety as we work to research and develop new treatment options for advanced cancers,” Anthony Lombardo, interim CEO of Advaxis, said in a company-issued press release. “We are 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.”

The FDA placed a clinical hold on a phase 1/phase 2 clinical trial designed to evaluate the combination of axalimogene filolisbac plus durvalumab for the treatment of HPV-associated cervical or head and neck cancers, according to one of the agent’s manufacturers.

The FDA implemented the clinical hold after receiving a safety report that indicated a patient in the trial died after experiencing respiratory failure after the sixth cycle of treatment in the trial.

Researchers were studying axalimogene filolisbac (Axal, Advaxis) — a Listeria monocytogenes-based immunotherapy — in combination with the PD-L1 inhibitor durvalumab (Imfinzi, AstraZeneca), for the treatment of recurrent or refractory HPV-associated cervical cancer and HPV-associated head and neck cancer.

Patient enrollment and further dosing will remain on hold while the patient’s death is investigated.

“We care deeply for our patients and for their safety as we work to research and develop new treatment options for advanced cancers,” Anthony Lombardo, interim CEO of Advaxis, said in a company-issued press release. “We are 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.”