Study overview
Niktimvo was studied in 79 people who had received a stem cell transplant, received at least 2 prior treatments for chronic graft-versus-host disease (GVHD), and weighed at least 88.2 pounds (40 kg).
Most people achieved a response with Niktimvo
A response to treatment with Niktimvo was defined as:
- A resolution of all signs and symptoms of chronic GVHD (complete response), or
- Improvement in at least one affected area without worsening signs or symptoms in other areas (partial response)
75% of people (59 out of 79)
experienced a response
Some people saw a fast response
Of the people who responded to treatment, half saw their first response in
6 weeks or less
The time to first response ranged from 4 weeks to 22 weeks.
Niktimvo provided lasting responses
More than half (60%) of the people who showed a response to Niktimvo continued to respond
for at least 1 year
People achieved responses in multiple affected organs
A complete or partial response in each organ was evaluated by recording changes in chronic GVHD severity from the beginning of the study to the end.
Click on the tiles below for more information about organ(s).
Eyes
30%
17 out of 59 people
whose eyes were affected saw a response
Mouth
52%
21 out of 40 people
whose mouth was affected saw a response
Esophagus
78%
18 out of 23 people
whose esophagus was affected saw a response
Lungs
47%
15 out of 32 people
whose lungs were affected saw a response
Liver
40%
4 out of 10 people
whose liver was affected saw a response
Digestive tract
85%
17 out of 20 people
whose digestive tract was affected saw a response
Joints/muscles
76%
42 out of 55 people
whose joints/muscles were affected saw a response
Skin
26%
16 out of 64 people
whose skin was affected saw a response
Niktimvo offered symptom improvement
44 out of 79 people who received Niktimvo (56%) reported improvement in the specific chronic GVHD symptoms assessed in the study.
Symptom improvement was defined as a reduction in chronic GVHD symptoms compared to the start of the study.
