Dr Ahluwalia on the SURVIVE Trial of SurVaxM Plus Chemoradiation in Newly-Diagnosed Glioblastoma

"We're really excited about this trial that has been fully enrolled now. Hopefully in the next several months, we will have the first interim analysis, which will give us the first evaluation of how well the vaccine is tolerated and what the efficacy results are."

Manmeet Singh Ahluwalia, MD, MBA, FASCO, chief, Medical Oncology, chief scientific officer, deputy director, Fernandez Family Endowed Chair, Cancer Research, Baptist Health Miami Cancer Institute; neuro-oncologist, Miami Neuroscience Institute, discusses the ongoing phase 2b SURVIVE trial (NCT05163080) evaluating a 15-amino-acid-peptide-conjugate survivin vaccine (SurVaxM) plus chemotherapy and radiation in patients with newly-diagnosed glioblastoma.

The randomized, placebo-controlled study builds on encouraging results from a prior phase 2a study (NCT02455557), which demonstrated a median OS of approximately 25.9 months in patients receiving SurVaxM, Ahluwalia begins. This exceeds the 16-month survival rate typically seen in newly diagnosed glioblastoma, he notes. SurVaxM also stimulated survivin-directed antibodies and anti-tumor cytotoxic T lymphocytes and was well tolerated, with primarily mild injection site reactions, he states, adding that several patients remained progression-free for over 5 years.

SURVIVE is enrolling eligible patients across 15 sites in the United States to assess the efficacy and safety of SurVaxM, Ahluwalia continues. Patients included in the study must be 18 years or older, have normal organ function, a Karnofsky Performance Status of at least 70, and undergo surgical resection with 1 or less cm³ residual MRI contrast enhancement within 72 hours post-resection. They must also receive temozolomide. Exclusion criteria include recurrent, multicentric, brainstem- or cerebellar-origin glioblastoma, as well as use of TTFields or other immunotherapies. Patients will be randomly assigned in a 3:2 ratio to the SurVaxM arm or saline control arm, respectively, he details.

The trial involves 3 phases: the vaccine priming phase, where SurVaxM or placebo is administered every 2 weeks for 4 doses beginning within 4 weeks after completing chemoradiation; the temozolomide phase, which starts after at least one vaccine dose; and the vaccine maintenance phase, where SurVaxM or placebo is given every 8 weeks starting 8 weeks after priming, Ahluwalia says. Temozolomide administration overlaps with both the priming and maintenance phases.

The trial’s primary end point is median overall survival (OS). Secondary end points include OS and progression-free survival (PFS) at 15, 18, and 24 months, median PFS, and toxicity. The study is designed to detect a 1-year OS of 75% in the SurVaxM arm compared with 60% in the control arm, he explains. With an anticipated sample size of 228 patients (137 in the SurVaxM arm, 91 in the control arm), an interim analysis will occur after 50% of deaths.

The SURVIVE trial has fully enrolled ahead of schedule, and upcoming interim results are expected to provide insight into the vaccine’s safety and efficacy, Ahluwalia states. These findings may confirm SurVaxM’s potential as a novel immunotherapy option for newly diagnosed glioblastoma, he concludes.