Imvax Inc. announced positive results from an ongoing phase Ib clinical trial that demonstrate treatment with IGV-001, the company’s novel autologous tumor cell vaccine, outperformed standard of care with prolonged overall survival and progression-free survival in patients with newly diagnosed glioblastoma multiforme.
The results, which were presented today in an oral presentation during the Advances in Novel Immunotherapeutics session at the American Association for Cancer Research Annual Meeting 2019, support the continued development of a new immunotherapy paradigm for the treatment of GBM.
The phase Ib trial evaluated the safety and efficacy of IGV-001, an autologous vaccine made from patients’ tumor cells and an antisense formulation, in adults with newly diagnosed GBM. Thirty-three patients received one of four vaccine exposures.
SOC treatment (radiotherapy and temozolomide) was initiated four to six weeks after vaccine administration. The primary endpoint was safety and the secondary endpoint was tumor response. Exploratory objectives included assessment of PFS, OS and immune markers. A historical comparator group comprised of 35 newly diagnosed GBM patients treated at the same center evaluated SOC alone.
Treatment with IGV-001 was well tolerated, and 15 of 33 patients (45.5%) experienced no tumor growth as of March 1. Moreover, the cohort treated with the highest vaccine dose demonstrated an improvement of 7.3 months in OS (21.9 months vs. 14.6 months per Stupp) and 3.5 months in PFS (10.4 months vs. 6.9 months when compared against the historical comparator group; p=0.031) against SOC treatment alone.
The most prominent survival statistics included those patients with DNA methylation of the MGMT promoter which favors temozolomide treatment. However, PFS for methylated patients was three-fold longer (30.9 months vs. 10.3 months for historic SOC patients per Hegi). This finding is under further investigation for its benefit.
IGV-001 has been developed over the past 20 years at Thomas Jefferson University Hospital in Philadelphia, where three phase I trials directed by Andrews and Hooper have now demonstrated efficacy and safety.
IGV-001 is a first-in-class autologous vaccine in development for the treatment of newly diagnosed glioblastoma multiforme, a lethal and common type of brain tumor. Based on early clinical research, one treatment with IGV-001 has the potential to trigger a multi-pronged immune response, including a short-term innate immune response followed by longer-term powerful adaptive immune activity, that is selectively directed at the patients’ tumor cells.
IGV-001 has been granted orphan drug designation for the treatment of malignant glioma by FDA and the European Medicines Agency.
