Personalized vaccine improves PFS in newly diagnosed glioblastoma
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A personalized cancer vaccine improved PFS compared with historical outcomes with standard-of-care treatment for patients with newly diagnosed glioblastoma, according to phase 2 study results.
The findings — presented at the virtual Society for Immunotherapy of Cancer Annual Meeting — also showed the vaccine was well-tolerated.
Survival outcomes typically are poor for patients with primary glioblastoma, but adjunctive vaccines offer the potential to improve survival by enhancing or inducing immune responses, according to study background.
AV-GBM-1 (AIVITA Biomedical) consists of autologous dendritic cells loaded with autologous tumor antigens derived from self-renewing tumor-initiating cells. The treatment — administered in a series of subcutaneous injections — targets multiple antigens from autologous tumor-initiating cells that contribute to rapid disease growth.
Daniela A. Bota, MD, PhD, associate professor of neurology and medical director of the neuro-oncology program at University of California, Irvine, and colleagues conducted a multicenter trial to assess AV-GBM-1 for patients with primary glioblastoma.
Achieving 75% survival at 15 months after intent-to-treat enrollment served as the primary objective.
Eligibility criteria included age less than 70 years at the time of tumor resection, successful glioblastoma cell culture, successful monocyte collection by leukapheresis, and Karnofsky Performance Status of at least 70 after surgical recovery.
Researchers enrolled patients after surgery but prior to initiation of standard concurrent temozolomide and radiation therapy.
Investigators differentiated dendritic cells from autologous monocytes, then incubated dendritic cells with autologous tumor antigens from the glioblastoma cell line-lysate to create each patient-specific vaccine.
Patients received subcutaneous injections at weeks 1, 2, 3, 8, 12, 16, 20 and 24, with doses suspended in 500 mcg granulocyte-macrophage colony-stimulating factor.
The intention-to-treat analysis included 60 patients (median age, 59 years; range, 27-70; 70% men; 71.6% white). Mean Karnofsky Performance Status was 83.2 (range, 70-100).
Bota and colleagues presented data on 57 patients who had received a combined 380 doses. Thirty-two patients had completed all eight doses. Sixteen patients received fewer than the scheduled eight doses when they discontinued treatment, and nine patients remained on treatment at data cutoff.
Follow-up for surviving patients ranged from 7.2 months to 24.2 months.
Researchers reported median PFS of 10 months (95% CI, 8.5-11.5), compared with median PFS of 6.9 months (95% CI, 5.8-8.2) observed in the landmark study that established the standard treatment for patients with newly diagnosed disease.
Researchers also reported a 38% reduction in risk for progression or death at 6.9 months compared with historical rates.
No patient discontinued treatment due to toxicity. However, 28 had been hospitalized for a combined 53 treatment-emergent central nervous system-related adverse events. These included seizures (15 episodes), increased focal weakness and/or falls (13 episodes), and severe headaches or visual changes (three episodes).
“The improvement [among patients with glioblastoma] who were treated with AV-GBM-1, compared to studies with the standard of care, is a very promising indication that our therapy confers benefit to patients in need,” Robert O. Dillman, MD, chief medical officer of AIVITA, said in a company-issued press release.
Reference: Bota D, et al. Abstract 319. Presented at: Society for Immunotherapy of Cancer Annual Meeting (virtual); Nov. 9-14, 2020.
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