Phase 2B Study Explores I/O Vaccine for Treatment of Newly Diagnosed Glioblastoma Patients

After treatment with SurVaxM in patients with newly diagnosed glioblastoma significantly improved survival, investigators are continuing the evaluation of the agent in a phase 2b clinical trial.

SurVaxM, a peptide mimic immunotherapy is being investigated for the treatment of patients with newly diagnosed glioblastoma in the phase 2b SURVIVE clinical trial (NCT05163080), according to a press release issued by Roswell Park Comprehensive Cancer Center.1

In a prior study, treatment with SurVaxM in patients with newly diagnosed glioblastoma significantly improved survival. During the study (NCT024455557), 63 patients were evaluated for 6-month progression-free survival (PFS), 12-month overall survival (OS), and immunologic response. Results showed that 96.8% of patients did not experience disease progression within 6 months of treatment, and the 12-month OS rate was 93.5% compared with 65% observed with historical controls. The median OS was 14.7 months.2

Further, the immunogenicity of the vaccine was promising, and the toxicities were limited.

In the prospective, randomized, placebo-controlled, multi-center SURVIVE trial, investigators will assess 265 patients with newly diagnosed glioblastoma on treatment with SurVaxM with sargramostim plus adjuvant oral temozolomide (Temodar) in the experimental arm or saline-montanide emulsion plus adjuvant oral temozolomide in the comparator arm. The primary end point of the study is OS, and the secondary end points include the number of grade 3/4 toxicities, PFS, OS at specified time points, and PFS at specified time points. Exploratory end points to be assessed in the study include predictive value of perfusion-weighted imaging, objective image-based tumor response rate, and evaluate molecular predictors of response to SurVaxM.3

“For years, we’ve struggled to move the needle as far as good treatment options for glioblastoma. Our hope is that SurVaxM will offer patients both longer survival and better quality of life,” said, principal investigator Ajay Abad, MD, a neurologic oncologist and faculty member in the Department of Neuro-Oncology, and assistant professor at Roswell Park Comprehensive Cancer Center, in the press release.1 “To hopefully be on the precipice of meaningful progress against glioblastoma and to be able to possibly see my patients outside of the hospital—years after their diagnosis—would be incredible.”

To be included in the study, patients must be 18 years of age or older with a Karnofsky performance status ≥ 70, pathologically confirmed diagnosis of glioblastoma of the cerebrum, adequate laboratory values, and available results from a tumor MGMT methylation and a tumor IDH1 mutation test.3

In terms of prior treatment, patients must have completed initial radiation therapy and be 16 weeks post-surgery. Patients must not show evidence of progressive disease post chemoradiation and those on dexamethasone at enrollment must be receiving less than 4 mg daily.

The study includes patients with previously treated glioblastoma and other brain cancers. Patients who previously received prior immunotherapy, tumor treating fields, or bevacizumab (Avastin) are ineligible to enroll as are patients with certain infections or disorders that may interfere with the investigational study treatment.

Currently, patients who meet the inclusion criteria are being recruited at the Roswell Park Comprehensive Cancer Center in Buffalo, New York as well as Atlantic Health in Summit, New Jersey, and the Dana-Farber Cancer Institute in Boston, Massachusetts.

References:

1. Roswell Park opens phase 2B randomized clinical trial of promising brain cancer immunotherapy. News release. Roswell Park Comprehensive Cancer Center. February 4, 2022. Accessed February 7, 2022. https://bit.ly/3rA9A0M

2. Phase II trial shows favorable response for patients receiving combination therapy with SurVaxM. News release. Roswell Park Comprehensive Cancer Center. June 1, 2019. Accessed February 7, 2022. https://bit.ly/3gwN16x

3. SurVaxM plus adjuvant temozolomide for newly diagnosed glioblastoma (SURVIVE). Clinicaltrials.gov. Accessed February 7, 2022. https://bit.ly/34mgT3b