Sponsored by
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.