Axalimogene filolisbac is Advaxis’s investigational Lm Technology immunotherapy, while durvalumab is MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor.
Around 66 patients will be included in the two-part, open-label Phase I/II trial, which will evaluate the safety and efficacy of axalimogene filolisbac as a monotherapy and in combination with durvalumab.
The Phase I is a dose-confirmation combination study with axalimogene filolisbac and durvalumab, which is expected to establish the maximum tolerated dose.
The trial’s Phase II portion will randomize patients to receive axalimogene filolisbac monotherapy, durvalumab monotherapy, or the combination.
The primary efficacy endpoints of the Phase I/II trial include objective response rate and progression-free survival.
Advaxis president and chief executive officer Daniel O’Connor said: "We are pleased to have initiated patient enrollment for this combination immunotherapy study and look forward to evaluating this immunotherapy combination in the clinic, with the hopes of confirming the preclinical anti-tumor effects.
"The initiation of our combination immunotherapy study with MedImmune adds to what has become a rapidly expanding clinical development pipeline for Advaxis involving our Lm Technology immunotherapy platform alone and in combination with potentially synergistic technologies."
Both axalimogene filolisbac and durvalumab are members of a new class of immunotherapies, which are designed to improve the body’s own defenses in fighting cancer.