How ROMVIMZA
can help
How ROMVIMZA
can help
For use in adult patients only.
For use in adult patients only.
ROMVIMZA was studied
in one of the largest
clinical trials for
TGCT, MOTION
MOTION was a randomized, double-blind,
placebo-controlled, phase 3 study that
included 123 patients with TGCT.
How did doctors study ROMVIMZA in MOTION?
At 25 weeks (approximately 6 months), doctors compared the data from patients on ROMVIMZA to patients on placebo (a pill with no active medication)- Doctors evaluated:
- Tumor response through scans, to see if a patient's tumor is shrinking while they take ROMVIMZA. They looked at both and
- Range of motion, to see how far a patient's joint can bend or move while they take ROMVIMZA
- A patient's physical function or how they could move and do everyday activities
- How ROMVIMZA could help more patients experience a reduction in pain
Who took part in MOTION:
- 123 patients with TGCT for whom surgery could have made the symptoms worse or caused severe problems
- 83 patients were randomized to receive ROMVIMZA
- 40 patients were randomized to placebo
- Patients who have and have not had surgery for TGCT
The benefits of
ROMVIMZA may include:
Shrinking tumors, even making tumors disappear in some patients- Improving range of motion and physical function
- Less pain
- Proven safety data studied in real patients
ROMVIMZA: Proven tumor reduction when compared to placebo at ~6 months
(Study endpoints were measured at 25 weeks, which is approximately 6 months)
Tumor Length:
40% (33/83) of patients taking ROMVIMZA saw their tumors get smaller
(compared to 0% of patients taking placebo)
- 35% of patients saw their tumor get at least 30% smaller
- 5% of patients had their tumors disappear completely
Doctors assessed this by using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Tumor Volume:
67% (56/83) of patients taking ROMVIMZA saw their tumors get smaller
(compared to 0% of patients taking placebo)
- 63% of patients saw their tumor get at least 50% smaller
- 5% of patients had their tumors disappear completely
Doctors assessed this by using Tumor Volume Score (TVS)
After ≥2 years of follow-up in the MOTION study,
more patients on ROMVIMZA saw their tumors shrink*
- Chance to be tumor-free: Nearly 1 in 4 patients (19 out of 83) were disease-free with 2 years of follow-up
- 48% of patients on ROMVIMZA (40 out of 83) saw their tumors shrink with 2 years of follow-up, which increased from 40% (33 out of 83) at the earlier check-in at 25 weeks (about 6 months)
*This is a descriptive analysis which is used to summarize and understand data without predicting future outcomes.
At 25 weeks, patients taking ROMVIMZA experienced ~5x greater improvement in range of motion compared with those on placebo
This means patients saw a nearly 20% improvement (18.4%) in range of motion
(how easily they could move their joint),
vs 3.8% in patients taking placebo.
AVERAGE RANGE OF MOTION ACHIEVED WITH ROMVIMZA: 83.6%
Range of motion or ROM is a
measurement of how far a joint can move.
In the MOTION study, patients treated with ROMVIMZA achieved an average of 83.6% ROM.
Using the knee as an example, this would be 112° compared with 92° for placebo, or 68.3%. Because different activities require different amounts of movement, the examples below may help show what those numbers mean in everyday life.
Here are some examples of
range of motion:
Walking on level ground = 65°
Patients taking ROMVIMZA reported significantly improved physical function and pain compared to those taking placebo
At approximately 25 weeks or
6 months, doctors examined:
Physical function
Pain
Improvements in physical function and
pain for some patients on ROMVIMZA were
seen at 5 weeks
(the first assessment).
Even some patients who took ROMVIMZA who did not have a tumor response experienced improvements in range of motion, pain, and/or physical function†
†These data are from an exploratory analysis at Week 25 and were not prespecified (meaning it was not specifically designed to find differences). Results should be interpreted with caution and considered descriptive (meaning these results should be viewed as observations).
Ask about ROMVIMZA
Our doctor discussion guide can help guide the conversation
between you and your care team.
