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2019 ASCO: Combination Therapy With SurVaxM in Newly Diagnosed Glioblastoma

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Key Points

  • SurVaxM generated encouraging efficacy and immunogenicity in patients with newly diagnosed glioblastoma, with minimal toxicity or side effects.
  • The majority of patients (96.8%) did not experience disease progression within 6 months of treatment, and 93.5% were alive 1 year after diagnosis, compared to an expected 65% survival rate based on historical comparisons.

Ahluwalia et al shared research results on SurVaxM at the 2019 ASCO Annual Meeting, reporting that combination therapy with the immunotherapy vaccine was more effective than standard therapy for nearly all patients with newly diagnosed glioblastoma in a phase II trial (Abstract 2016).

SurVaxM (SVN53-67/M57-KLH) was developed at Roswell Park Comprehensive Cancer Center in Buffalo, New York, by Robert Fenstermaker, MD, Chair of Neurosurgery, and Michael Ciesielski, PhD, Assistant Professor of Neurosurgery. The vaccine is a new and unique cancer immunotherapy designed to stimulate a multifaceted immune response targeting survivin, a tumor-survival antigen not generally present in nonmalignant cells.

Results were reported from a five-center, single-arm phase II clinical trial, in which 63 patients with newly diagnosed glioblastoma with a median age of 60 years were followed for safety, 6-month progression-free survival, 12-month overall survival, and immunologic response. All patients underwent standard treatment involving craniotomy, radiation, and treatment with temozolomide both before and after surgery. Immune response was assessed by detection of a survivin-specific antibody and CD8-positive T-cell levels.

Study Results

The team reported that, compared to a historical analysis of patients receiving standard therapy alone, combination therapy with SurVaxM generated encouraging efficacy and immunogenicity in patients with newly diagnosed glioblastoma, with minimal toxicity or side effects. The majority of patients (96.8%) did not experience disease progression within 6 months of treatment, and 93.5% were alive 1 year after diagnosis, compared to an expected 65% survival rate based on historical comparisons.

“We essentially saw significant increase[s] in both progression-free and overall survival, which [are] noteworthy in patients with such a notoriously aggressive and treatment-resistant disease,” said Dr. Fenstermaker, senior author on the study.

“We were especially pleased to see that even patients with poor prognostic factors like high levels of survivin responded well to this combination of standard therapy plus SurVaxM,” added study coauthor Dr. Ciesielski.

SurVaxM was awarded Orphan Drug designation by the U.S. Food and Drug Administration in 2017. New studies incorporating SurVaxM are expected to open at both the Cleveland Clinic and Roswell Park in the coming months.

Disclosure: For full disclosures of the study authors, visit coi.ascopubs.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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