Snub,
Yes agree may have been small trial, but probably helped in deciding to conduct AIM2CERV much more as a preventive therapy, to prevent reoccurrence.
FAWCETT trial is in a patient population that is much sicker having failed prior therapies, including PD1, so results are pretty good so far.
Axalimogene filolisbac: Anal Cancer Program
Cathy Eng, MD, FACP, of the University of Texas MD Anderson Cancer Center, provided an update on the phase 2 FAWCETT study of axalimogene filolisbac as a monotherapy for metastatic anal cancer. The FAWCETT study is a multi-center, open-label, two-stage study designed to evaluate the efficacy and safety of axalimogene filolisbac as a monotherapy in patients with HPV-associated metastatic anal cancer who have received at least one prior treatment regimen for advanced disease. Dr. Eng, the principal investigator of the study, reported that data from 29 of the planned 31 evaluable patients enrolled in Stage 1 met the predefined 6-month progression free survival rate, paving the way for stage 2 of the study. Dr. Eng also noted that one patient experienced a durable partial response lasting greater than 6 months (after progression on prior anti-PD-1 therapy). Stable disease was reported in 7 patients (24%) and a disease control rate of 28% was also reported. Treatment was well tolerated with mostly grade 1-2 infusion related AEs that resolved successfully with standard care; common (≥ 30%) treatment related AEs (TRAEs) included grade 1-2 chills/rigors, fever, hypotension and vomiting.
Advaxis is evaluating whether to continue to the second stage of the monotherapy trial, or initiate a registrational-quality study in combination with a checkpoint inhibitor in the same patient population later this year.
