Advaxis’ axalimogene filolisbac shows mettle against metastatic cervical cancer
PRINCETON, N.J.—Advaxis Inc., a clinical-stage biotechnology company developing cancer immunotherapies, and the Gynecologic Oncology Group (GOG, now part of NRG Oncology), recently announced clinical data from stage 1 of an ongoing two-stage Phase 2 study (GOG-0265) of Advaxis’s lead Lm Technology immunotherapy, axalimogene filolisbac (ADXS-HPV), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) who have progressed on at least one prior line of systemic therapy. The stage 1 data showed that treatment with axalimogene filolisbac resulted in a 38.5 percent 12-month overall survival rate in 26 patients.
Evaluation of safety data showed that grade 1 or 2 adverse events occurred in 19 out of 26 patients (73 percent), with fatigue, chills and fever being the most common. Four patients (15 percent) experienced a grade 3 adverse event (hypotension and cytokine release syndrome) and one patient (4 percent) experienced a grade 4 adverse event (lung infection and sepsis).
“Patients with PRmCC who have failed at least one line of therapy face a life-threatening condition with an estimated survival of four to seven months and no available treatment options,” said Dr. Tom Herzog, clinical director at the University of Cincinnati Cancer Institute. “The stage 1 results for axalimogene filolisbac, which show 12-month survival, are a meaningful step forward in meeting the needs of women who require second-line treatment for PRmCC.”
The GOG has conducted over 17 studies of a diverse set of investigational agents and regimens, but never has the 12-month overall survival rate exceeded 30 percent in people with PRmCC. Stage 2 of the GOG-0265 study is currently enrolling and the protocol has been amended by GOG to allow for continuous cycles of treatment until disease recurrence (the stage 1 protocol provided for three doses of axalimogene filolisbac over 3 months).
“The axalimogene filolisbac data presented at AGOS by the GOG and Dr. Herzog represent some of the most encouraging Phase 2 data to date in metastatic cervical cancer and support the results previously observed in Advaxis’ own Phase 2 study,” said Daniel J. O'Connor, president and CEO of Advaxis. “Advaxis is grateful to NRG Oncology and the GOG for having the foresight several years ago to design, sponsor and conduct this study.”