After Patient Dies, FDA Imposes Clinical Hold on Trial of Advaxis/AstraZeneca Combination

Advaxis has acknowledged that the FDA has placed on clinical hold its Phase I/II cancer combination treatment study assessing its axalimogene filolisbac (ADXS11-001) with AstraZeneca’s Imfinzi ® (durvalumab), following the death of a patient last month.

The combination study is designed to assess the axalimogene filolisbac/Imfinzi combo in patients with advanced, recurrent, or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. Following the trial’s sixth combination cycle, a patient developed respiratory failure and died, Advaxis disclosed yesterday.

“Over the course of the treatment cycle, this patient received 11 doses of AXAL and 21 doses of durvalumab. 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,” Advaxis interim CEO Anthony Lombardo told analysts yesterday on ...