Treatment with the investigational oral vaccine VXM01 in combination with Bavencio (avelumab) demonstrated both safety and tolerability in patients with recurrent glioblastoma, according to data from an open-label phase 2a clinical trial that was reported in a news release from Vaximm AG, a subsidiary of OSR Holdings, Inc.
These final results from the clinical trial concluded the phase 2a study which assessed the safety and tolerability of VXM01 in combination with the PD-L1 inhibitor. The combination was generally well tolerated, with most side effects being mild to moderate. Notably, the safety profile was consistent with previous data on Bavencio alone, with no new safety concerns observed for the combination. Moreover, no serious side effects were linked to VXM01, while 81.8% (nine of 11) of serious side effects were related to the underlying disease.
Glossary:
Oral vaccine: a form of delivery distinct from injection.
Objective response rate: the percentage of patients who have a partial response or complete response to the treatment within a certain period of time.
Overall survival: length of time from either the date of diagnosis or the start of treatment that a patient is still alive.
Time to progression: the length of time from the date of diagnosis or the start of treatment for a disease until the disease starts to get worse or spread to other parts of the body.
Progression-free survival: length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Among patients with non-resected disease, the objective response rate was 12%; of these patients, 12% experienced partial remission and 4% had stable disease. According to the release, these data suggest further research on VXM01 combined with PD-L1 inhibitors like Bavencio in this difficult-to-treat population. In patients with resected disease, overall survival ranged from 2.2 to 46.5 months.
Despite the small sample size (25 patients), the median time to progression of 2.7 months and median overall survival of 11.1 months prompt further research when looking to the typical prognosis for recurrent glioblastoma, where reported median progression-free survival is 1.5 to six months and median overall survival ranges from two to nine months. Additionally, the release noted that tumor shrinkage was observed in responding patients, regardless of baseline tumor size. A preliminary biomarker analysis also identified potential predictive and pharmacodynamic markers associated with VXM01-induced tumor response.
The reported safety and tolerability data, together with early indications for the potential relevance of a VXM01 dependent, VEGFR-2 specific immune response in GBM therapy warrant further study.
“The completion of this Phase 2a study is a significant milestone for Vaximm AG, as it provides strong evidence that VXM01, in combination with avelumab is generally well-tolerated in patients with recurrent glioblastoma,” Dr. Constance Hoefer, chief executive officer of Vaximm AG, said in the news release. “We are encouraged by these early results and the potential to improve outcomes for patients with this aggressive cancer. We remain committed to advancing VXM01 as a key therapeutic candidate for the treatment of glioblastoma, other cancers and other diseases where VXM01 may have positive impact on treatment outcomes”
Based on these safety and tolerability data, as well as early indications that VEGFR-2 specific immune response may be relevant for glioblastoma therapy, VXM01 warrants further study according to the news release.
More Information on the Investigative Agent
VXM01 is an oral immunotherapy designed to help the body’s own immune system fight cancer. It works by training immune cells, called T cells, to attack the blood vessels that supply tumors with nutrients. In some cancers, including brain tumors, it may also help the immune system target cancer cells directly.
This treatment is based on a weakened, safe bacterial vaccine that has been modified to carry a specific cancer-related target called VEGFR2. When taken orally, VXM01 stimulates the immune system to produce “killer” T cells that attack tumor blood vessels. By doing so, it allows more immune cells to enter the tumor, potentially making the treatment more effective.
Moreover, preclinical studies in animals have shown that VXM01 can slow tumor growth in several types of cancer. Based on this research, investigators evaluated the therapy in a double-blind, randomized, placebo-controlled phase 1 study in patients with advanced pancreatic cancer. The trial evaluated 71 patients, and in this population, VXM01 appeared to be safe and well tolerated, as well as significantly improved patient survival through the activation of VEGFR2-specific cytotoxic T cells.
Evidence of clinical activity, including measurable tumor responses and improved survival, has been observed with VXM01 treatment in recurrent glioblastoma.
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