Dr. Ahluwalia on the Evaluation of SurVaxM With Temozolomide in Newly Diagnosed Glioblastoma

Manmeet Singh Ahluwalia, MD, chief, Tumor Medical Oncology, chief scientific officer, deputy director, Miami Cancer Institute, discusses the evaluation of SurVaxM in combination with oral temozolomide (Temodar) in patients with newly diagnosed glioblastoma.

SurVaxM is a peptide mimic immunotherapeutic vaccine that targets survivin, a cell-survival protein present in 95% of glioblastomas and many other cancers. Survivin is associated with negative prognostic value, and patients with high survivin expression in glioblastoma tend to have worse outcomes than those with a lower expression, Ahluwalia emphasizes. Despite advances in radiation, chemotherapy, and surgery, outcomes for patients with glioblastoma remain poor, with average survival ranging from 15 to 18 months, Ahluwalia says.

A phase 2 trial (NCT02455557) evaluated the safety and efficacy of SurVaxM in combination with temozolomide in patients with newly diagnosed glioblastoma. The trial 64 patients with resected newly diagnosed glioblastoma, including 38 men and 26 women ranging from 20 to 82 years of age. 

Patients underwent maximal safe resection, followed by 6 weeks of chemotherapy and radiation prior to enrolling on the study. Patients received standard-of-care adjuvant temozolomide plus SurVaxM every 2 weeks in the induction phase for a total of 4 doses, followed by the vaccine given every 12 weeks in the maintenance phase in the absence of disease progression or unacceptable toxicity.

Data from the trial showed patients experienced a median overall survival of 25.9 months. Investigators noted that efficacy was observed in both the methylated and unmethylated patient population. Regarding safety, SurVaxM was well tolerated, and the vaccine represents a promising therapy for patients with newly diagnosed glioblastoma, Ahluwalia says.

The phase 2b SURVIVE trial (NCT05163080) will continue to evaluate SurVaxM plus temozolomide in patients with newly diagnosed glioblastoma. Patients will be randomly assigned to receive SurVaxM plus temozolomide or temozolomide alone. The trial is open at more than 10 centers in the United States, and investigators plan to open the trial at a total of 20 sites, Ahluwalia concludes.