Data from the GOG-0265 study were presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
GOG-0265 is a single arm, phase 2 trial evaluating Axalimogene filolisbac for the treatment of persistent or recurrent metastatic ( squamous or non-squamous cell ) carcinoma of the cervix ( PRmCC ).
The primary endpoints of the study were to assess the safety and efficacy of Axalimogene filolisbac in women with persistent or recurrent metastatic carcinoma of the cervix. The primary efficacy endpoint was overall survival at 12 months from initial treatment with Axalimogene filolisbac.
The primary safety endpoints were to evaluate the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.
The final efficacy results of GOG-0265 demonstrated that 38% of patients ( n = 19/50 ) with heavily pretreated persistent or recurrent metastatic carcinoma of the cervix were alive 12 months following treatment with Axalimogene filolisbac.
The GOG-0265 study protocol used a logistic model-based calculation to establish the expected 12-month survival rate. The model identified the key prognostic factors of age, race and performance status significantly related to survival from a database of approximately 500 patients with persistent or recurrent metastatic carcinoma of the cervix who participated in 17 previous phase 2 studies conducted by the Gynecologic Oncology Group ( GOG ), now part of NRG Oncology.
Using this model, the expected 12-month survival rate of patients enrolled in the study was calculated to be 24.5%.
As a result, the 38% 12-month survival rate of patients treated with Axalimogene filolisbac represents a 52% improvement over the expected survival rate and is the highest 12-month survival rate achieved to date in this setting.
The probability of this survival improvement being detected by chance versus a true treatment effect was calculated to be 0.02. A compelling and ongoing complete response of 18.5 months was observed and the longest ongoing survival is 40.6 months.
The safety profile was consistent with previous clinical experience. The most common grade 1 or grade 2 treatment-related adverse events ( TRAEs ) were hypotension and symptoms related to cytokine release ( e.g., nausea, chills, fever ).
Eighteen out of 50 patients experienced a grade 3 TRAE and two out of 50 patients experienced a grade 4 TRAE, which were hypotension and symptoms related to cytokine release.
Cervical cancer is the fourth most common cancer in women worldwide. An estimated 13,000 new cases will be diagnosed in the United States in 2016, and 4,100 people will die of the disease, according to the National Cancer Institute ( NCI ).
Persistent HPV infection is the most important factor in the development of cervical cancer.
According to the ICO Information Centre on HPV and Cervical Cancer, about 4.4% of women in the United States are estimated to harbor high-risk cervical HPV infection at a given time, and about 72% of cervical cancers are attributed to high-risk HPV strains.
Persistent or recurrent metastatic carcinoma of the cervix is a fatal disease, and the prognosis for women with advanced and recurrent cervical cancer remains poor, with survival of only 4 to 7 months following failure of first-line treatment, research has shown.
There is no therapy following failure of first-line treatment.
According to the American Cancer Society ( ACS ), the five-year mortality rate for metastatic disease is at just 17%, with the area continuing to be a high unmet medical need. ( Xagena )
Source: Advaxis, 2017