Advaxis said Friday that the FDA lifted a clinical hold on a Phase I/II study investigating axalimogene filolisbac in combination with AstraZeneca's Imfinzi (durvalumab) for the treatment of patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. Shares in Advaxis jumped as much as 68 percent on the news.
The trial had been placed on hold in March after the submission of a safety report to the FDA regarding a patient death involving respiratory failure after nine months of combination therapy. According to Advaxis, new guidelines for the early detection and treatment of similar rare events have been agreed with the agency and will be implemented for the study.
"We are pleased to have resolved this issue…and will implement these guidelines across Advaxis' portfolio as needed," remarked CEO Kenneth Berlin. Axalimogene filolisbac is a targeted Listeria monocytogenes-based immunotherapy designed to treat HPV-associated cancers.
The news comes shortly after Advaxis said that it plans to withdraw its European conditional marketing authorisation application for axalimogene filolisbac to treat metastatic cervical cancer in patients who progress beyond first-line therapy. The company noted that its decision was based on feedback from the European Medicines Agency, with the regulator indicating that additional data are likely to be needed to support a conditional approval.
In 2014, AstraZeneca entered a collaboration to study its anti-PD-L1 immune checkpoint inhibitor Imfinzi, previously known as MEDI4736, in combination with Advaxis' cancer immunotherapy vaccine axalimogene filolisbac, previously dubbed ADXS-HPV. However, Advaxis recently decided to reduce internal investment in axalimogene filolisbac, and will instead seek partnership opportunities for the therapy in most HPV-associated cancers, including cervical cancer. For related analysis, read ViewPoints: Fresh off a clinical hold, it's back to the drawing board for Advaxis.
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