Latest News

• MimiVax and Roswell Park Announce Results from Phase 2b SURVIVE Trial of SurVaxM in Newly Diagnosed Glioblastoma        

  Initial results from the SURVIVE randomized, placebo-controlled trial of SurVaxM added to standard of care treatment for newly diagnosed glioblastoma (GBM) showed that, among 233 evaluable patients, median overall survival was 22.8  months with SurVaxM versus 20.3 months with placebo. This survival difference did not reach statistical significance. However, in the prespecified subgroup of patients aged 65 and under, the median survival difference of 24.2 months versus 20.2 months was statistically significant (p = 0.019). Further, the 30-month overall survival rate was 42% with SurVaxM versus 18% with placebo in this younger subgroup. The trial enrolled adults with newly diagnosed GBM, good functional status (Karnofsky score of at least 70), minimal residual tumor after surgery (no more than 1 cm³ of enhancement on MRI within 72 hours), and no progression after standard radiation and temozolomide. 

  SurVaxM was generally well tolerated. Common side effects included injection-site reactions (48%), pain (41%), redness (39%), itching (38%), swelling (29%) and flu-like symptoms (13%). While the trial did not meet its primary endpoint, the results are particularly encouraging for patients 65 and under. It is worth noting that the placebo group lived longer than the 16-month historical benchmark, making the study's comparison more challenging. SurVaxM remains investigational, but MimiVax plans to discuss the results and potential expedited approval pathways with the FDA.

  
  
• Alpheus Medical Opens Enrollment in New Clinical Trial for Butterfly Glioblastoma        

  'Butterfly glioblastoma' is when a GBM tumor crosses the brain's midline through the corpus callosum. These tumors account for an estimated 2-6% of GBM cases and are particularly challenging to treat. Because treatment options are limited and clinical trials specifically for these patients are limited, this new trial evaluating the investigational combination of 5-ALA with low-intensity diffuse ultrasound offers an important opportunity for a group with significant unmet need. 

  
  
• Neoadjuvant PD1 plus CTLA-4 immune checkpoint blockade in surgically resectable recurrent glioblastoma        

  A window-of-opportunity trial in recurrent GBM found that neoadjuvant (pre-surgery) dual immunotherapy with nivolumab (Opdivo) and ipilimumab (Yervoy) significantly increased the number of immune cells infiltrating the tumor compared with placebo. Median overall survival was 402 days among patients who received the dual immunotherapy (including patients who received the combo both before and after surgery and those who received it only after surgery), compared with 273 days for those who got nivolumab alone. Exploratory analyses also found increased activity in blood markers associated with immune system activation for patients receiving the dual treatment. Higher levels of tumor-infiltrating immune cells and early signs of immune activation were associated with improved survival, while tumor mutational burden was not. These results show that dual checkpoint blockade can activate immune responses in GBM, and we hope to see further studies to validate whether this strategy can help improve survival outcomes. 

  
  
• Adjuvant Radiotherapy Reduced Recurrence in Resected Atypical Meningioma        

  A phase 3 randomized trial of 157 patients found that radiation after complete surgical removal of a grade 2 atypical meningioma significantly reduced recurrence compared with observation. At five years, 80% of patients who received radiation remained disease free, compared with 64% of those who were just observed. The trial supports radiation after complete resection, but treatment decisions should still depend on individualized clinical circumstances and the balance of benefits and risks.  

  
  
• Scientists uncover two-pronged strategy to overcome glioblastoma's resistance to immunotherapy        

  In a preclinical study, researchers at The Wistar Institute in Pennsylvania found a combination that improved immunotherapy results in glioblastoma mouse models. They used low-dose axitinib to reduce oxygen deprivation (hypoxia) in tumors, which can cause immune cells called myeloid cells to suppress cancer-fighting T cells. They then added a treatment that activates a certain receptor on T cells to strengthen their ability to attack the tumor. The combination extended median survival in mice from 17 days in untreated controls to 42 days, and 40% of the mice survived long term. The surviving mice also showed evidence of lasting immune memory against the tumor. The findings suggest a potential new approach to overcoming immune suppression in GBM, but clinical trials are needed to determine whether the combination is safe and effective in humans.

  
  
• New glioblastoma patient podcast        

  Struck by Lightning: A GBM is a new podcast that follows H. Gulick, a longtime paramedic and senior FBI agent diagnosed with GBM, as he navigates treatment and life with brain cancer. Through candid conversations with his friend Tim Mayer, H shares his experiences with treatment, family, uncertainty and the realities of living with GBM, offering support and connection to other patients and caregivers.