On June 26, 2017 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company developing cancer immunotherapies, reported that the European Society of Gynaecologic Oncology (ESGO) has accepted an abstract for a poster presentation at its 2017 congress on the identification of potential baseline biomarkers indicative of survival benefit from treatment with the company’s lead immunotherapy candidate, axalimogene filolisbac (Press release, Advaxis, JUN 26, 2017, View Source [SID1234519687]). ESGO is Europe’s landmark gynecologic oncology meeting. Held biennially, ESGO congress brings together professionals to learn and discuss the latest medical and scientific developments in gynecologic cancers research, treatment and care.
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Advaxis researchers identified certain pre-treatment baseline levels of serum proteins that were strongly associated with overall survival (OS) benefit in patients with persistent or recurrent metastatic carcinoma of the cervix (PRmCC) that were treated with axalimogene filolisbac in the Phase 2 GOG/NRG-0265 study. The 12-month survival rate in this study was 38 percent (19/50), and these results were presented at a medical meeting earlier this year.
This analysis of pre-treatment baseline serum proteins of 45 patients from the study showed that levels of a group of four closely-aligned proteins were strongly correlated with OS. One cluster of patients (n=25), had relatively lower levels of all four proteins and exhibited an OS of 56 percent, while the second cluster (n=20), with relatively higher levels, exhibited an OS of 15 percent. These data are statistically significant (HR=0.23; 95% CI: 0.10-0.48; P<.001) and suggest that the baseline levels of these analytes have prognostic value for OS, and high levels of these individual proteins were negatively associated with clinical outcomes in the trial.
Importantly, it was found that much of this effect was due to levels of one particular protein, which was found to be most highly correlated with OS in the study. This particular protein was previously not known to be associated with survival in cervical cancer. Advaxis will continue to evaluate this particular protein as a potential biomarker to help identify patients most likely to benefit from treatment with axalimogene filolisbac.
"In the field of cancer immunotherapy, biomarkers have been playing an increasing role in guiding patient selection and identifying early indicators of treatment response," said Robert Petit, Chief Scientific Officer of Advaxis. "The discovery of this potential biomarker, which previously has not been known to be associated with survival in cervical cancer, is significant and could be a biomarker to predict efficacy, similar to how PD-L1 expression is used as a biomarker for checkpoint inhibitors. PD-L1 testing has become an important and routine strategy to guide treatment, and this biomarker has the promise to do the same for axalimogene filolisbac."
Sandy Hayes, PhD, Associate Director of Research and Biomarker Lead at Advaxis, is the first author and presenter of "Baseline Serum Protein Levels Associated with Survival in Axalimogene Filolisbac (Axal)-Treated Metastatic Cervical Cancer Patients: The GOG/NRG-0265 Trial." The poster will be presented at ESGO 2017, held Nov. 4 to 7 in Vienna, Austria, and will also be published in a supplement to the International Journal of Gynecological Cancer.
About Cervical Cancer
Cervical cancer is the fourth most common cancer affecting women worldwide. An estimated 13,000 cases were diagnosed in the United States in 2016, and 4,100 women will have this disease as their cause of death each year, according to the National Cancer Institute. Decades of research have shown that persistent HPV infection, particularly with high-risk virus types such as HPV-16 and HPV-18, is the most important factor in the development of cervical cancer. The prognosis for women with advanced and recurrent cervical cancer remains poor, with median survival of only six to seven months following initiation of palliative treatment with chemotherapy. According to the American Cancer Society, the five-year survival rate for stage IV disease is at 15 to 16 percent. There is no approved therapy following failure of first-line treatment, and there has been limited advancement in developing new therapeutics for advanced cervical cancer over the last 30 years.
About Axalimogene Filolisbac
Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack.
Axalimogene filolisbac has received Fast Track designation as an adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) patients and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. Axalimogene filolisbac is the only active product candidate to have received the U.S. FDA orphan drug designation in cervical cancer.
Advaxis, in collaboration with Bristol-Myers Squibb, is evaluating ADXS-DUAL, the next generation immunotherapy candidate targeting HPV-associated cancers, with the PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), as a potential combination treatment option for women with metastatic cervical cancer. Expected to start by the end of 2017, the study will evaluate this combination regimen in women with PRmCC who have failed at least one prior line of systemic chemotherapy.