Imvax, Inc., a clinical-stage biotechnology company focused on the development of novel patient-specific vaccines and immunotherapy strategies, announced positive results from an ongoing Phase 1b clinical trial that demonstrate treatment with IGV-001, the company’s autologous tumor cell vaccine, outperformed standard of care (SOC) with prolonged overall survival (OS) and progression-free survival (PFS) in patients with newly diagnosed glioblastoma multiforme (GBM). The results, which were presented in an oral presentation during the Advances in Novel Immunotherapeutics session at the American Association for Cancer Research (AACR) Annual Meeting 2019, support the continued development of a new immunotherapy paradigm for the treatment of GBM.
The Phase 1b 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 (i.e., 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 percent) experienced no tumor growth as of March 1, 2019. 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 Stupp1) 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 Hegi2). This finding is under further investigation for its benefit.