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AV-GBM-1 showed early promise in an interim overall survival analysis of an ongoing phase II trial in patients with newly diagnosed glioblastoma.
AV-GBM-1 showed early promise in an interim overall survival (OS) analysis of an ongoing phase II trial in patients with newly diagnosed glioblastoma, according to Aivita Biomedical, Inc., the company developing the immunotherapy.
At both 12 and 15 months, the OS rate among 50 evaluable patients receiving AV-GBM-1 was 76%. Although the study is a single-arm, open-label trial, as described on ClinicalTrials.gov (NCT03400917), Aivita included data in a press release from a 287-patient control arm of individuals receiving standard of care. The OS data for the AV-GBM-1 cohort compared favorably to this control arm, which showed OS rates of 61% and 48% at 12 and 15 months, respectively.
"Although treatment and monitoring of patients is ongoing, we are very encouraged by these interim results," Robert O. Dillman, MD, chief medical officer, Aivita, said in the press release. "We completed accrual to the trial ahead of schedule, thanks to the engagement of our clinical site principal investigators and a truly outstanding manufacturing success rate at Aivita.”
The company explained the mechanism of action of AV-GBM-1 in its press release. “AV-GBM-1 is a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor antigens derived from self-renewing tumor-initiating cells. The treatment is administered in a series of subcutaneous injections as an adjunctive therapy. The treatment is uniquely panantigenic, targeting multiple antigens on autologous tumor-initiating cells responsible for the rapid growth of the disease and resistance to standard therapy.”
Overall, the phase II trial has met its target recruitment of 55 patients. Treatment is occurring at 8 clinical sites, including 6 in California and 1 each in Kentucky and New Jersey. Patients are receiving AV-GBM-1 as an adjunctive therapy following primary surgery plus concurrent chemoradiation. OS is the primary endpoint.
Beyond glioblastoma, Aivita is also conducting 2 other clinical trials of AV-GBM-1 in other tumor types. An open-label, single-arm phase Ib trial is evaluating the safety and efficacy of AV-GBM-1 combined with PD-1 inhibitors in patients with metastatic melanoma. Recruitment has not yet started for this trial (NCT03743298).
The other trial, which is accruing patients with ovarian cancer, is a double-blind phase II study with a target enrollment of 99 patients (NCT02033616). The trial is randomizing patients in a 2:1 ratio to AV-GBM-1 or autologous monocytes as a comparator.
The AV-GBM-1 results are the second piece of promising news reported this week from the glioblastoma pipeline. On Tuesday, Kazia Therapeutics Limited reported that treatment with paxalisib (formerly GDC-0084), the company’s investigational small molecule inhibitor of the PI3K/AKT/mTOR pathway, was associated with a positive OS signal in patients with glioblastoma, according to interim data from an ongoing phase II study.
In a small 9-patient subgroup, the median OS was 17.7 months with paxalisib, which compares favorably with the 12.7-month OS demonstrated in this setting with the approved standard of care, temozolomide. Among a slightly larger subgroup of 30 patients, the median progression-free survival (PFS) was 8.5 months, which again compares favorably with the demonstrated median PFS with temozolomide of 5.3 months in this setting.
Kazia anticipates reporting additional data later this year and final results in the first half of next year. Beyond this phase II study 4 other ongoing studies are exploring paxalisib in patients with different types of brain cancer.