FDA Grants Fast Track Designation to SurVaxM in Newly Diagnosed Glioblastoma

Michael Ciesielski

The FDA has granted fast track designation to the investigational vaccine SurVaxM for the treatment of patients with newly diagnosed glioblastoma.¹

SurVaxM is a first-of-its-kind immunotherapy that stimulates the immune system to attack survivin, which is present in 95% of glioblastomas. Immune assays have shown that SurVaxM generates survivin-specific CD8-positive T cells, resulting in anti-tumor antibody/immunoglobulin G titers that are associated with survival.^2,3

"The receipt of fast track designation affirms the importance of new clinical developments of novel therapies to improve the treatment and outcomes for patients with newly diagnosed glioblastoma," Michael Ciesielski, chief executive officer of MimiVax, stated in a press release.¹ "This designation is a key component in our journey to help patients with glioblastoma to live longer."

The vaccine is being investigated in the phase 2b SURVIVE trial (NCT05163080), in which patients will be randomly assigned to SurVaxM plus standard-of-care temozolomide or temozolomide monotherapy. Previous data derived from the 2a portion of the randomized, double-blind, placebo-controlled study were published in the Journal of Clinical Oncology in March 2023. Results showed that SurVaxM appeared to be safe and well tolerated when combined with temozolomide in patients with newly diagnosed glioblastoma.⁴ Sixty-four patients with resected glioblastoma were enrolled in the trial, and 63 were evaluable. A total of 60 patients remained progression-free 6 months after diagnosis. Median progression-free and overall survival were 11.4 months and 25.9 months, respectively. Notably, survivin-specific CD8-positive T cells and antibody/immunoglobulin G titers were produced with the vaccine and patients with both methylated and unmethylated disease derived clinical benefit with SurVaxM.

Patients in the trial are treated with 4 doses of SurVaxM at 500 μg once every 2 weeks in Montanide ISA-51 emulsion plus 100 μg of sargramostim subcutaneously following craniotomy and fractionated radiation therapy with concurrent temozolomide.

To enroll, patients must be 18 years of age or older, have a Karnofsky performance status of 70 or higher, and have a confirmed diagnosis of glioblastoma of the cerebrum, with available results from tumor MGMT methylation and IDH1 mutation tests. Furthermore, patients’ clinical laboratory values must meet all pre-specified thresholds within 14 days prior to registration and patients must not have active bleeding or be at high risk of bleeding. Patients who have previously undergone biopsy and definitive surgical resection may still be eligible if randomization occurs within 16 weeks of surgery.⁵

Patients will be excluded from study enrollment if they have recurrent or progressive glioblastoma; gliosarcoma; anaplastic astrocytoma; oligodendroglioma; ependymoma; low-grade glioma; any histology other than glioblastoma; multicentric glioblastoma or glioblastoma involving the brainstem or cerebellum, or leptomeningeal or spinal extension present at diagnosis. Additional exclusion criteria include residual contrast enhancement greater than 1 cm3 on post-operative scan obtained within 72 hours of surgery; previous exposure to non-standard radiation therapy for glioblastoma; and prior or concurrent immunotherapy for a brain tumor.

MimiVax is focused on completing the phase 2b portion of the SURVIVE trial before navigating SurVaxM through the FDA approval process. The SURVIVE trial is now recruiting for the 2b portion of the study across 11 cancer centers in the United States.

References

1. MimiVax granted fast track designation from FDA for SurVaxM for newly diagnosed glioblastoma. News release. MimiVax. October 12, 2023. Accessed October 12, 2023. https://www.mimivax.com/mimivax-granted-fast-track-designation-from-fda-for-survaxm-for-newly-diagnosed-glioblastoma/
2. SurVaxM. MimiVax. Accessed October 12, 2023. https://www.mimivax.com/survaxm/
3. Clinical trial of Roswell Park’s SurVaxM glioblastoma vaccine reveals promising results. News release. Roswell Park. December 16, 2022. Accessed October 12, 2023. https://www.roswellpark.org/newsroom/202212-clinical-trial-roswell-parks-survaxm-glioblastoma-vaccine-reveals-promising-results
4. Ahluwalia MS, Reardon DA, Abad AP, et al. Phase IIa study of SurVaxM plus adjuvant temozolomide for newly diagnosed glioblastoma. J Clin Oncol. 2023;41(suppl 7)1453-1465. doi:10.1200/JCO.22.00996
5. SurVaxM plus adjuvant temozolomide for newly diagnosed glioblastoma (SURVIVE). ClinicalTrials.gov. Updated July 12, 2023. Accessed October 12, 2023. https://clinicaltrials.gov/study/NCT05163080?term=NCT05163080&rank=1