Gemogenovatucel-T Immunotherapy for Ovarian Cancer Maintenance
Posted: Thursday, February 11, 2021
The VITAL study, published in The Lancet Oncology, tested whether gemogenovatucel-T, an autologous tumor cell vaccine manufactured from harvested tumor tissue, was safe and effective as maintenance therapy for women with stage III or IV ovarian cancer. Although recurrence-free survival, the study’s primary endpoint, was not reached, the treatment was found to be well tolerated. The results suggested that gemogenovatucel-T may benefit some patients with a BRCA wild-type mutation, though further investigation is necessary.
“Gemogenovatucel-T is…easily administered and shows promising efficacy, potentially making it an ideal maintenance therapy for patients with ovarian cancer,” Rodney P. Rocconi, MD, of the University of South Alabama, Mobile, and colleagues stated.
The research team randomly assigned 91 women to receive gemogenovatucel-T (n = 47) or placebo (n = 44). Eligible patients had stage III or IV high-grade serous, endometrioid, or clear cell ovarian cancer.
The median follow-up after the first dose of gemogenovatucel-T and placebo was 40.0 months and 39.8 months, respectively. Patients assigned to receive gemogenovatucel-T had a recurrence-free survival of 11.5 months (7.5 months to not reached). By contrast, patients who received the placebo had a recurrence-free survival of 8.4 months (7.9–15.5 months)
The research team reported no grade 3 or 4 toxic events among the gemogenovatucel-T arm. In the placebo group, two patients reported five grade 3 toxicities, including arthralgia, bone pain, generalized muscle weakness, syncope, and dyspnea. Serious adverse events were reported in four patients in the placebo arm and three patients in the gemogenovatucel-T arm. No treatment-related deaths occurred in either group.
“Future studies of gemogenovatucel-T are justified in combination with checkpoint inhibitors, PARP inhibitors, and angiogenesis inhibitors,” the research team concluded.
Disclosure: For full disclosures of the study authors, visit thelancet.com.
