A trial comparing blinatumomab with chemotherapy for acute lymphoblastic leukaemia (TOWER)

Cancer type:

Acute leukaemia

Acute lymphoblastic leukaemia (ALL)

Blood cancers

Leukaemia

Status:

Results

Phase:

Phase 3

This trial compared blinatumomab with chemotherapy for people who have acute lymphoblastic leukaemia (ALL).

It was for people with ALL that hadn’t responded to treatment or had come back after treatment.

This trial was open for people to join between January 2014 and September 2015. These results were published in 2017 and 2018.

More about this trial

Doctors usually treat ALL with different chemotherapy drugs. But sometimes treatment doesn’t work and the ALL gets worse or comes back. Researchers hoped that blinatumomab would help these people.

Blinatumomab is a type of targeted cancer drug called a monoclonal antibody. Monoclonal antibodies can seek out cancer cells by looking for particular proteins on the cells’ surface.

The aim of this trial was to find out how well blinatumomab worked for acute lymphoblastic leukaemia when compared to chemotherapy.

Summary of results

The trial team found that blinatumomab worked better than chemotherapy for people with ALL that hadn’t responded to treatment or came back after.

About this trial

This was a phase 3 trial. 405 people joined the trial.

Everyone was put into 1 of 2 treatment groups. Neither they nor their doctor chose which group they were in. It was a randomised trial.

Of the 405 people who joined the trial.

271 people were to have blinatumomab
134 people were to have chemotherapy

12064_tower.png

Of the 405 people, 376 had at least one cycle of treatment. When the researchers looked at how well treatment worked they included all 405 people. This is an intention to treat analysis Open a glossary item

Results

At 12 weeks after the start of treatment, the team looked at how well their ALL had responded to treatment. This is the remission rate. To do this they looked at bone marrow samples Open a glossary item

and blood cell counts Open a glossary item

The percentage of people who had no sign of their leukaemia and their blood cell counts had completely recovered was:

34 out of every 100 people (34%) in the blinatumomab group
16 out of every 100 people (16%) in the chemotherapy group

12064_tower_-_2.png

The overall total percentage of people who had no sign of leukaemia including people whose blood count had recovered completely, partly or not at all was:

44 out of every 100 people (44%) in the blinatumomab group
25 out of every 100 people (25%) in the chemotherapy group

The average length of time there was no sign of their leukaemia was:

just over 7 months (7.3) for people in the blinatumomab group
just over 4½ months (4.6) for people in the chemotherapy group

The team looked at how many people were alive and had no sign of their leukaemia 6 months after treatment. They found it was:

31 out of every 100 people (31%) in the blinatumomab group
12 out of every 100 people (12%) in the chemotherapy group

12064_tower_-_3.png

The researchers looked at how long people lived after treatment. On average this was:

just over 7½ months (7.7) for people in the blinatumomab group
4 months for people in the chemotherapy group

In both groups, 24 out of every 100 people (24%) had a stem cell transplant with someone else’s cells (allogeneic transplant Open a glossary item

)

Side effects

Nearly everyone in each group who had treatment had at least one side effect.

The researchers looked at how many people had serious side effects. They found that it was:

231 people (87%) in the blinatumomab group
100 people (92%) in the chemotherapy group

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

33 people (12%) in the blinatumomab group
9 people (8%) in the chemotherapy group

The most common side effects that caused people to stop treatment were:

infections
headaches, dizziness, difficulty sleeping, tremors and fits (and other such neurological problems)

Quality of life

In general, people in the blinatumomab group reported a better quality of life during and after treatment than those in the chemotherapy group.

There were 3 areas where people in the blinatumomab group reported a worse quality of life. These were:

difficulty sleeping
performing everyday social tasks and maintaining a social life (social functioning)
money related problems (financial difficulties)

Conclusion

The trial team concluded that blinatumomab compared to chemotherapy:

worked well for people with ALL that hadn’t responded to treatment or came back after
was acceptable
gave a better quality of life

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.