Brain cancer vaccine misses main goal but helps younger patients
A vaccine for glioblastoma, a deadly brain cancer, missed the main goal of its trial. It did not help patients live significantly longer overall. But patients 65 and younger who got the vaccine lived about four months longer on average than those who got a placebo.
A vaccine for glioblastoma, the most common and aggressive brain tumor in adults, missed the main goal of a mid-stage trial, Fierce Biotech and CancerNetwork reported.
The vaccine, called SurVaxM, was tested against a placebo in 233 patients with newly diagnosed glioblastoma. Patients who got the vaccine lived a median of 22.8 months, compared with 20.3 months on placebo, both outlets reported.
That difference did not meet the usual test for statistical significance, CancerNetwork said. The developer, MimiVax, said the result missed the study's primary goal, Fierce Biotech reported.
The results were better in a group of patients 65 and younger, which was chosen before the trial began. In that group, median survival was 24.2 months with the vaccine versus 20.2 months on placebo, both outlets said.
About 42% of younger patients who got the vaccine lived 30 months or longer, compared with 18% on placebo, CancerNetwork reported.
"For patients 65 and under, this is one of the strongest signals we have seen in newly diagnosed glioblastoma in a long time," said Dr. Robert Fenstermaker, a leader of the trial and co-founder of MimiVax, according to CancerNetwork.
MimiVax CEO Michael Ciesielski told Fierce Biotech there has not been a new drug for glioblastoma in more than 20 years. "There's nothing else to offer them, so any improvement is significant," he said.
The vaccine targets survivin, a protein found in about 95% of these tumors, both outlets reported. The most common side effects were mild reactions where the shot was given, CancerNetwork said. Grade 3 or higher side effects occurred in 48% of vaccine patients and 46% of placebo patients.
MimiVax was spun out of Roswell Park Comprehensive Cancer Center in Buffalo, New York, Fierce Biotech said. The developers plan to ask the FDA for a meeting to discuss the data and faster paths to approval, CancerNetwork reported.
What we know: The vaccine missed its main goal but helped patients 65 and younger.
What we don't: Whether the FDA will consider it for approval.
Where outlets agree Fierce Biotech and CancerNetwork both report median survival of 22.8 versus 20.3 months overall and 24.2 versus 20.2 months in patients 65 and younger.
Where they differ The outlets cited here report the same key facts so far.