A trial looking at IMA950 vaccine and GM-CSF for glioblastoma

The trial team found that in many people taking part, the immune system responded to the IMA950 vaccine.

The trial recruited 45 people in 2 groups. Everybody taking part had standard treatment as well as the vaccine and GM-CSF. The standard treatment after surgery to remove glioblastoma was a combination of chemotherapy and radiotherapy (chemoradiotherapy), then a break before having the chemotherapy drug temozolomide on its own.

• People in group 1 started having IMA950 and GM-CSF injections after their surgery and a week or 2 before starting chemoradiotherapy
• People in group 2 started the injections at least a week after finishing chemoradiotherapy, and 4 weeks before starting temozolomide alone

Everybody taking part had up to 11 injections over a period of nearly 6 months.

More than 2 out of 10 people (20%) had the following side effects during treatment

• Feeling or being sick
• A reaction where they had the injections
• Tiredness (fatigue)
• Headache
• Hair loss
• Dizziness
• Fits (seizures)
• Constipation
• Cough
• Skin rash

But as people were also having standard treatment, these were not necessarily caused by the IMA950 or GM-CSF injections. Only a small number of people had severe side effects. These side effects included a drop in white blood cells, tiredness and weakness (fatigue) and 1 person had an allergic reaction (anaphylaxis).

The researchers were able to look at the effect of the vaccine in 40 of the people who took part. When planning the trial, they had decided that if more than 3 out of 10 people taking part (30%) had a good immune response to the vaccine, they would recommend developing it further. They found that in group 1, there were good immune responses in 9 out of 19 people (47%). And in group 2, there were good immune responses in 11 out of 21 people (52%).

They also looked at the number of people who were living without any sign of their tumour getting worse after treatment. Researchers call this progression free survival. They found that after 6 months tumours had not become worse in more than 7 out of 10 people taking part (74%), and after 9 months it was just over 3 out of 10 people (31%).

The latest research from the trial team has found that 6 people were alive 2 years after they first had treatment with IMA950 and GM-CSF. The average time people lived after having the trial treatment was just over 15 months.

The researchers concluded that having IMA950 and GM-CSF injections alongside standard treatment for glioblastoma multiforme is safe and doesn’t cause too many severe side effects. Because of the number of people who had good immune responses, the researchers think the IMA950 vaccine should be developed further.

We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (peer reviewed ) but may not have been published in a medical journal.  The figures we quote above were provided by the trial team. We have not analysed the data ourselves.