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Northwest drug helps glioblastoma patients live longer in phase 3 trial

Northwest Biotherapeutics Inc. said its immunotherapy-based medicine DCVax-L helped patients with a type of brain cancer live longer in an ongoing phase 3 trial.

The Bethesda, Md.-based developer of immunotherapies said the phase 3 trial designed with two-thirds of patients with newly diagnosed glioblastoma receiving the vaccine DCVax-L, along with standard treatment that included chemotherapy with temozolomide, while the remaining one-third received placebo plus temozolomide.

When the patients' tumor recurred, patients in both arms of the study were given DCVax-L but without being unblinded as to what they had received before tumor recurrence. Northwest said that due to the crossover design, about 90% of the 331 patients received DCVax-L.

According to interim data from the trial, all patients lived for a median of almost 2 years, or 23.1 months. The company said the median survival period for patients with newly diagnosed glioblastoma receiving the current standard of care is 15 to 17 months.

Top 100, or about 30% of the total patients, lived for a median of almost 3.5 years, or 40.5 months, from the time of their surgery to remove the tumor.

Northwest said that 131 patients with a specific gene alteration, the methylated MGMT gene status, showed a median survival of almost 3 years, or 34.7 months, after their surgery. With the current standard of care treatment, median survival for these patients has been reported in the literature as 21.7 months.

In 162 patients who had the unmethylated MGMT gene status, the median period of survival was 19.8 months from surgery. The median survival for these patients has been reported in the literature as 12.7 months with the standard of care treatment.