A trial of depatuxizumab mafodotin for glioblastoma that has come back (INTELLANCE 2)

Cancer type:

Brain (and spinal cord) tumours

Status:

Results

Phase:

Phase 2

This trial looked at depatuxizumab mafodotin (Depatux-M, ABT-414) with or without temozolomide. It was for people with glioblastoma that came back after their first treatment (surgery and or radiotherapy). 

It was open to people whose glioblastoma had a larger number of receptors for the protein called epidermal growth factor (EGF).

This trial was open for people to join between 2015 and 2016. The trial team published the results in 2020.

More about this trial

Doctors can use temozolomide and lomustine to treat glioblastoma that has come back. The researchers are always looking to improve treatments.

Depatuxizumab mafodotin (Deptux-M) is a type of drug called an antibody drug conjugate (ADC). There are 2 parts to an ADC. The first part targets cancer cells by attaching to a particular receptor on the surface of the cancer cell. The second part is a toxin that goes into the cancer cell and kills it.

Depatux-M attaches to the epidermal growth factor receptors (EGFR) on cancer cells. An earlier study suggested that people whose glioblastoma has a large number of EGF receptors may benefit from Depatux-M.

In this trial the researchers compared:

  • Depatux-M
  • Depatux-M and temozolomide
  • standard treatment (temozolomide or lomustine)

The aims of this trial were to find out:

  • which is the best treatment 
  • how safe is Depatux-M by itself and in combination with temozolomide compared to standard treatment

Summary of results

The trial team found that there might be a possible role for Depatux-M with temozolomide in treating glioblastoma that has EGFR. And when their tumour has come back after the first treatment.  

About this trial
This was a phase 2 trial. 260 people took part in the trial. 

It was a randomised Open a glossary item trial. A computer put everyone into 1 of 3 treatment groups. 

  • 88 people had Depatux-M with temozolomide.
  • 86 people had Depatux-M.
  • 86 people had standard treatment (25 had temozolomide and 61 had lomustine).

Results
The team looked at how many people were still alive 1 year and 2 years after treatment. At 1 year it was:

  • 35 people (39.7%) in the Depatux-M and temozolomide group
  • 23 people (26.7%) in the Depatux-M group
  • 24 people (28.2%) in the standard treatment group

At 2 years it was:

  • 17 people (19.8%) in the Depatux-M and temozolomide group
  • 9 people (10%) in the Depatux-M group
  • 4 people (5.2%) in the standard treatment group


 

They also looked at the median Open a glossary item length of time people had no sign of their tumour getting worse. It was:

  • just under 3 months (2.7) for people in the Depatux-M and temozolomide group
  • just under 2 months (1.9) for people in the Depatux-M group
  • just under 2 months (1.9) for people in the standard treatment group

The team looked at the median amount of time people were alive after treatment. They found it was:

  • just over 9½ months (9.6) for people in the Depatux-M and temozolomide group
  • just under 8 months (7.9) for people in the Depatux-M group
  • just over 8 months (8.2) for people in the standard treatment group

Side effects
The most common worst side effect reported by people having Depatux-M by itself or with temozolomide were eye problems. This included such things as:

  • pain on the outside of the eye or pain when blinking or moving the eye
  • feeling that something is in the eye
  • tearing
  • blurred vision 
  • redness
  • sensitivity to light 

Other side effects reported by people having Depatux-M included:

  • feeling sick
  • diarrhoea
  • an increase of a liver enzyme, bilirubin and glucose in the blood
  • tiredness (fatigue)
  • a drop in the numbers of blood cells
  • sore muscles and bones
  • problems with the nerves such as fingertips and toes being painful and or very sensitive to touching 
  • skin rash

The number of people in each group who stopped treatment because of side effects was:

  • 5 people in the Depatux-M and temozolomide group
  • 7 people in the Depatux- group
  • 9 people in the standard treatment group 

 
Conclusion
The trial team concluded that Depatux-M with temozolomide might be a possible treatment for people with glioblastoma. When it has an increased amounts of EGFR receptors. And when the tumour has come back after their first treatment with surgery and or radiotherapy. 

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Paul Mulholland

Supported by

AbbVie
Experimental Cancer Medicine Centre (ECMC)
European Organisation for Research and Treatment of Cancer (EORTC)

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13514

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Rhys was only four years old when he was diagnosed with a brain tumour

A picture of Rhys

"He went through six operations and was placed on a clinical trial so he could try new treatments.”

Last reviewed:

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