Maintenance with gemogenovatucel-T provides a durable survival benefit in patients with homologous recombination proficient (HRP) ovarian cancer, according to results published in Gynecologic Oncology. 1
The results are from the phase 2b VITAL study (ClinicalTrials.gov Identifier: NCT02346747) in which researchers compared gemogenovatucel-T and placebo maintenance.
The study enrolled 45 patients with stage IIIb-IV, resectable, HRP ovarian cancer who had achieved a complete response with adjuvant chemotherapy. The patients’ median age at baseline was 64 years (range, 46-84 years).
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Patients received 1 x 107 cells per injection of gemogenovatucel-T (n=25) or placebo (n=20) once a month for 4-12 doses. Patients continued to receive treatment until product exhaustion or disease progression.
Prior results from this study showed that gemogenovatucel-T improved recurrence-free survival (RFS) and overall survival (OS).2
The current analysis provides 3-year follow-up data. The median follow-up was 38.6 months from the first dose of gemogenovatucel-T and 38.4 months from the first placebo dose.
From randomization to follow-up, the median RFS was 10.6 months with gemogenovatucel-T and 5.7 months with placebo (hazard ratio [HR], 0.405, P =.011).
The median OS was not reached in the gemogenovatucel-T arm and was 26.9 months in the placebo arm (HR, 0.417; P =.020). The 3-year OS rate was 70% and 40%, respectively (P =.019).
According to the researchers, there was no difference in long-term post-relapse disease management that could potentially bias the OS or RFS results.
There were no grade 3-5 treatment-related adverse events and no cases of treatment-related myelodysplastic syndrome or acute myeloid leukemia reported.
The researchers concluded that these results “further support evidence of safety and durable benefit” with gemogenovatucel-T.
Disclosures: This research was supported by Gradalis, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
- Walter A, Rocconi RP, Monk BJ, et al. Gemogenovatucel-T (Vigil) maintenance immunotherapy: 3-year survival benefit in homologous recombination proficient (HRP) ovarian cancer. Gynecol Oncol. Published online October 23, 2021. doi:10.1016/j.ygyno.2021.10.004
- Rocconi RP, Monk B, Walter, A et al. Gemogenovatucel-T (Vigil) immunotherapy demonstrates clinical benefit in homologous recombination proficient (HRP) ovarian cancer. Gynecol Oncol. 2021;161(3):676-680. doi:10.1016/j.ygyno.2021.03.009
