Results of phase 2A single-arm trial assessing SurVaxM plus standard therapy highlighted in poster at ASCO 2022
Roswell Park Comprehensive Cancer Center Professor of Neurosurgery Michael Ciesielski, PhD, presented the most recent findings from the completed phase 2A study of the immunotherapy SurVaxM at a poster session in June at the American Society of Clinical Oncology (ASCO) 2022 annual meeting. The largest clinical cancer meeting in the world.
SurVaxM is an immunotherapy that targets survivin, a protein present in many cancer types that helps cancer cells stay alive. It was first developed at Roswell Park by Dr. Ciesielski and Chair of Neurosurgery Robert Fenstermaker, MD.
The five-center, single-arm phase 2A clinical trial (NCT02455557) enrolled 63 patients with newly diagnosed glioblastoma (nGBM), median age 60, who had completed initial chemoradiation. Outcomes assessed include progression-free survival, safety and immune response. Each patient completed standard treatment of craniotomy, radiation and treatment with temozolomide before receiving the priming doses of SurVaxM. Maintenance doses were administered every 12 weeks alongside temozolomide.
Dr. Michael Ciesielski
The authors report that 51% of patients on the study survived at least two years beyond diagnosis with glioblastoma, and 41% survived at least three years beyond diagnosis. Median survival for patients with standard therapy is 16 months.
Glioblastoma, while a rare disease, is the most common primary brain cancer. Fast-growing and aggressive, the cancer is typically treated with surgery, chemotherapy and radiation, but frequently recurs within a year of initial treatment.
“It is highly encouraging to see that many patients saw their tumors respond to the combination of SurVaxM and temozolomide,” says Dr. Ciesielski. “For such a rare but also deadly cancer, giving those with glioblastoma greater survival is always a step in the right direction. We’re excited to see this promising immunotherapy moving forward to larger studies and studies investigating other potential applications or disease settings.”
The Phase 2B randomized multicenter SURVIVE trial is ongoing at Roswell Park (NCT05163080), and a multicenter pilot study in patients with several pediatric brain tumor types has just opened (NCT04978727).
The research team gratefully acknowledges donations to Roswell Park, directly and through events like the Ride for Roswell, as critical support of their work to understand and advance this immunotherapy through all phases of study.
Dr. Ciesielski is CEO of MimiVax LLC, a company spun off from Roswell Park that is now developing SurVaxM.
Presenting author: Michael Ciesielski, PhD, Roswell Park Comprehensive Cancer Center
Time/date: Sunday, June 5, 8 a.m. CST
Session: Central Nervous System Tumors
Abstract number 2037, poster board 375