4:33 PM
Mar 12, 2018
 |  BC Extra  |  Clinical News

FDA places hold on Advaxis' combo trial

Advaxis Inc. (NASDAQ:ADXS) fell $0.49 (22%) to $1.72 in after-hours trading Monday after it said FDA placed a clinical hold on a Phase I/II trial of axalimogene filolisbac (ADXS11-001) in combination with PD-L1 inhibitor Imfinzi durvalumab to treat HPV-related cancers.

According to the company, the hold is related to a patient death reported on Feb. 27 involving respiratory failure following the sixth cycle of combination treatment in the trial. Advaxis said it will work with the site investigator and FDA to review the death and determine a path forward.

The trial is enrolling patients with advanced, recurrent or refractory HPV-associated cervical cancer or HPV-associated squamous cell carcinoma of the head and neck (SCCHN).

In February, Advaxis submitted a conditional MAA to EMA for axalimogene filolisbac as second-line treatment of persistent, recurrent or metastatic cervical cancer. The product is also in Phase II testing to treat anal cancer.

Axalimogene filolisbac is a live Listeria monocytogenes-based immunotherapy expressing E7 transforming protein (Human papillomavirus-16; HpV16gp2).

AstraZeneca plc (LSE:AZN; NYSE:AZN) markets Imfinzi in the U.S. to treat stage III unresectable non-small cell lung cancer (NSCLC) that has not progressed following chemoradiation. Imfinzi also has accelerated approval for the second-line treatment of locally advanced or metastatic urothelial carcinoma.

Advaxis, which announced the news after market close on Monday, was off $0.01 to $2.21.

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Extra

Article Purchase

Purchase this article for limited one-time distribution and website posting

$750 USD