ARTICLE | Clinical News

Axalimogene filolisbac: Phase II data

September 21, 2015 7:00 AM UTC

Data from 26 evaluable patients in stage 1 of the 2-stage, open-label, U.S. Phase II GOG-0265 trial showed that 1x10 9 colony forming units (CFUs) of axalimogene filolisbac every 28 days for 3 doses led to a 1-year OS rate, the primary efficacy endpoint, of 38.5%. Median OS was 7.7 months and median PFS was 3.1 months. In 19 evaluable patients, axalimogene filolisbac led to a clinical benefit rate (CBR) of 38.5%, including 1 partial response. Axalimogene filolisbac was well tolerated with fatigue, chills and fever reported as the most common adverse events. Four patients had a grade 3 adverse event of hypotension and cytokine release syndrome (CRS) and 1 patient had a grade 4 adverse event of lung infection and sepsis. The trial enrolled patients with persistent or recurrent metastatic squamous or non-squamous cell carcinoma of the cervix who have progressed on >=1 prior line of systemic therapy. The trial, which is sponsored by the Gynecologic Oncology Group (GOG), is enrolling about 38 patients in stage 2 to receive continuous cycles of axalimogene filolisbac until disease recurrence. Data were presented at the American Gynecological & Obstetrical Society meeting in Half Moon Bay. ...