Study Supports Promise of Innovative Immunotherapy Vaccine for Aggressive Brain Cancer

August 05, 2022

Researchers from Hackensack Meridian Health’s John Theurer Cancer Center participated in a multicenter study showing that a new cancer vaccine more than doubled the survival of patients with recurrent glioblastoma compared to historical controls. The findings suggest the vaccine has promising efficacy, and support its further evaluation in randomized clinical trials. The data was reported in June 2022 in the online journal Frontiers in Oncology.

Recurrent Glioblastoma (rGBM) is a brain cancer that is notoriously difficult to treat successfully, with an average survival from recurrence of only 8 months. Effective chemotherapy is limited by the blood-brain barrier (BBB), and immunotherapeutic approaches such as immune checkpoint inhibitors (iCI) have been largely ineffective in this disease.

This study treated 21 patients with recurrent glioblastoma with a vaccine called Sitoiganap, made from the patients’ own tumor tissue, along with the standard anticancer drugs cyclophosphamide, bevacizumab, and checkpoint inhibitors (nivolumab or pembrolizumab), plus GM-CSF (a medication which boosts white blood cell counts). The median time it took for a patient's cancer to progress (progression-free survival) was 9 months and the overall survival from study entry was 20 months from the date the patients entered the study. The treatment was very well tolerated, with few side effects.

"The outcomes we observed are excellent for this disease when compared with historical controls, who have an average overall survival of eight months, and progression free survival of only 2.4 months in prior reported clinical trials," said Samuel Singer, MD, a neuro-oncologist who directed John Theurer Cancer Center's participation in the study. "The findings show there may be a synergistic effect between the vaccine and the other treatments, suggesting that combination therapy may be the best way forward for the use of immunotherapy in people with GBM," Dr. Singer added.

About half of the study’s patients were treated at John Theurer Cancer Center.

Sitoiganap is a novel vaccine custom-made from cells from a patient's own tumor as well as certain cells from the brain tumors of other patients participating in the study.

“The vaccine does require the patient to have a surgery to remove tumor tissue from the brain prior to treatment,” explained Dr. George Kaptain, surgical director of the Brain and Spine Institute at John Theurer Cancer Center, who led the team collecting the tumor tissue. “It is gratifying to see tumor tissue that is removed as part of standard care get used as a therapeutic agent for our patients.”

The study offered patients the vaccine on a "Right-to-Try" (RTT) basis. RTT is a new regulatory pathway created in 2018, that allows patients access to investigational medications outside of a traditional clinical trial framework. The advantage to RTT over standard expanded access (EA) protocols - previously the only way for patients to receive non-FDA approved medications - lies in the comparative ease of running such protocols. The RTT framework cuts through much of the regulatory red tape that can delay EA protocols.

"RTT access to medication is offered to patients who are not eligible or cannot be treated on existing studies of the medication” explained Dr. Singer. “When used judiciously, these protocols can provide investigators confidence to move the product forward for more rigorous testing. At John Theurer Cancer Center, we are willing to explore the RTT framework when other institutions may be reluctant to do so, reflecting our commitment to providing our patients with timely access to the most promising therapeutics.”

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