ROMVIMZA was studied inMOTION: A global multicenter, randomized, double‑blind, placebo‑controlled, phase 3 study in 123 patients with symptomatic TGCT^1,2

Study design^1-3

Randomize 2:1; Part 1: double-blind 24 weeks; ROMVIMZA® (vimseltinib) (n=83) 30 mg twice weekly; Placebo (n=40) twice weekly; Primary/secondary endpoints; Part 2: open-label; 73/83 patients continued on ROMVIMZA® 30 mg twice weekly; 35/40 patients crossed over to ROMVIMZA® 30 mg twice weekly; Exploratory endpoints; Extension of treatment every 3 months

Key eligibility criteria³

Patients 18 years or older
Confirmed diagnosis of symptomatic TGCT for which surgical resection would potentially cause worsening functional limitation or severe morbidity

Key exclusion criteria³

Previous use of systemic therapy (investigational or approved) targeting CSF1 or CSF1R
- Previous treatment with imatinib or nilotinib was allowed

Tumor response at Week 25 (6 months)¹

Primary endpoint:

ORR by RECIST v1.1 (tumor length) per IRR

Key secondary endpoint:

ORR by TVS (tumor volume) per IRR

Symptomatic and Functional Outcomes at Week 25 (6 months)¹

Additional key secondary endpoints:

ROM:change from baseline in active ROM
Physical function:change from baseline
in PROMIS‑PF
Pain:patient-reported BPI-30 worst pain response rate

BPI=Brief Pain Inventory; CSF1=colony‑stimulating factor 1; CSF1R=colony‑stimulating factor 1 receptor; IRR=independent radiologic review; ORR=objective response rate; PROMIS‑PF=Patient‑Reported Outcomes Measurement Information System Physical Function (TGCT‑specific); RECIST v1.1=Response Evaluation Criteria in Solid Tumors version 1.1; ROM=range of motion; TGCT=tenosynovial giant cell tumor; TVS=tumor volume score.

The MOTION study included a patient population reflective of real‑world clinical experience—with the majority of study sites in Europe and North America^1,2

	ROMVIMZA n=83	Placebo n=40
Median (IQR) age, years	45 (33-53)	43 (31-53)
Sex
Female	46 (55%)	27 (68%)
Male	37 (45%)	13 (33%)
Region
Europe	57 (69%)	32 (80%)
USA and Canada	14 (17%)	5 (13%)
Australia	12 (14%)	2 (5%)
Asia	0	1 (3%)
Affected Joint
Knee	56 (67%)	27 (68%)
Ankle	9 (11%)	6 (15%)
Hip	11 (13%)	1 (3%)
Other^*	7 (8%)	6 (15%)
Prior TGCT surgery or procedure^†	64 (77%)	27 (68%)
0 surgeries	19 (23%)	13 (33%)
1 surgery	28 (34%)	14 (35%)
2-3 surgeries	26 (31%)	11 (28%)
≥4 surgeries	10 (12%)	2 (5%)
Prior TGCT systemic therapy	19 (23%)	9 (23%)^‡
Imatinib	16 (19%)	7 (18%)
Nilotinib	2 (2%)	4 (10%)
Other^§	1 (1%)	0

^*Includes foot, wrist, hand, shoulder, elbow, and temporomandibular joint.

^†All patients had histologically confirmed TGCT per diagnostic biopsy or existing pathology report; diagnostic biopsies were not recorded as a prior surgery or procedure.

^‡Two patients in the placebo arm received both imatinib and nilotinib.

^§Includes an investigational agent (BP 27 672).

IQR=interquartile range; USA=United States of America.

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References: 1. ROMVIMZA [package insert]. Waltham, MA: Deciphera Pharmaceuticals, LLC. 2. Gelderblom H, Bhadri V, Stacchiotti S, et al. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024;403(10445):2709-2719. 3. Gelderblom H, Bhadri V, Stacchiotti S, et al. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024;403(10445)(suppl):1-124.

IMPORTANT SAFETY
INFORMATION & INDICATION

Indications and Usage

ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

Important Safety Information

Warnings and Precautions

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hepatotoxicity:

Cases of serious and fatal liver injury have occurred with the use of another kinase inhibitor that targets CSF1R. Serious and fatal liver injury have not been observed with ROMVIMZA.
Elevated AST and ALT can occur with ROMVIMZA.
Avoid ROMVIMZA in patients with pre‑existing increased serum transaminases; total bilirubin or direct bilirubin (>ULN); or active liver or biliary tract disease, including ALP.
Monitor liver function tests prior to initiation of ROMVIMZA, twice a month for the first two months and once every 3 months for the first year of therapy and as clinically indicated thereafter. Withhold and reduce the dose, or permanently discontinue ROMVIMZA based on the severity of the hepatotoxicity.

Embryo-Fetal Toxicity:

ROMVIMZA may cause fetal harm when administered to pregnant women. Advise pregnant women on the potential risk to the fetus.
Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with ROMVIMZA and for 1 month after the last dose.

Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) and No. 6 (Sunset Yellow FCF):

ROMVIMZA 20 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic reactions (including bronchial asthma) in certain susceptible patients. FD&C Yellow No. 5 (tartrazine) sensitivity is frequently seen in patients who also have aspirin sensitivity.
Advise patients that ROMVIMZA 14 mg and 20 mg capsules contain FD&C Yellow No. 6 (Sunset Yellow FCF), which may cause allergic reactions.

Increased Creatinine without Affecting Renal Function:

Increases in serum creatinine can occur with the use of ROMVIMZA. These increases in serum creatinine may not be associated with changes in renal function. Increases in creatinine reversed upon ROMVIMZA discontinuation. During ROMVIMZA treatment, use alternative measures that are not based on serum creatinine to assess renal function.

Adverse Reactions:

The most common (≥20%) adverse reactions, including laboratory abnormalities that occurred in patients receiving ROMVIMZA were increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased ALT.

Drug Interactions:

P-glycoprotein (P-gp) substrates: Avoid concomitant use of ROMVIMZA with P-gp substrates. If concomitant use cannot be avoided, take ROMVIMZA at least 4 hours prior to P-gp substrates.
Breast Cancer Resistance Protein (BCRP) substrates: Avoid concomitant use of ROMVIMZA with BCRP substrates.
Organic Cation Transporter 2 (OCT2) substrates: Avoid concomitant use of ROMVIMZA with OCT2 substrates.
Concomitant use of vimseltinib with P-gp substrates, BCRP substrates or OCT2 substrates may increase exposure of these substrates.

Lactation: Advise females not to breastfeed during treatment with ROMVIMZA.

Please click for the full Prescribing Information.

Indications and Usage

IMPORTANT SAFETY
INFORMATION & INDICATION

Indications and Usage

Important Safety Information

Warnings and Precautions

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hepatotoxicity:

Cases of serious and fatal liver injury have occurred with the use of another kinase inhibitor that targets CSF1R. Serious and fatal liver injury have not been observed with ROMVIMZA.
Elevated AST and ALT can occur with ROMVIMZA.
Avoid ROMVIMZA in patients with pre‑existing increased serum transaminases; total bilirubin or direct bilirubin (>ULN); or active liver or biliary tract disease, including ALP.
Monitor liver function tests prior to initiation of ROMVIMZA, twice a month for the first two months and once every 3 months for the first year of therapy and as clinically indicated thereafter. Withhold and reduce the dose, or permanently discontinue ROMVIMZA based on the severity of the hepatotoxicity.

Embryo-Fetal Toxicity:

ROMVIMZA may cause fetal harm when administered to pregnant women. Advise pregnant women on the potential risk to the fetus.
Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with ROMVIMZA and for 1 month after the last dose.

Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) and No. 6 (Sunset Yellow FCF):

ROMVIMZA 20 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic reactions (including bronchial asthma) in certain susceptible patients. FD&C Yellow No. 5 (tartrazine) sensitivity is frequently seen in patients who also have aspirin sensitivity.
Advise patients that ROMVIMZA 14 mg and 20 mg capsules contain FD&C Yellow No. 6 (Sunset Yellow FCF), which may cause allergic reactions.

Increased Creatinine without Affecting Renal Function:

Increases in serum creatinine can occur with the use of ROMVIMZA. These increases in serum creatinine may not be associated with changes in renal function. Increases in creatinine reversed upon ROMVIMZA discontinuation. During ROMVIMZA treatment, use alternative measures that are not based on serum creatinine to assess renal function.

Adverse Reactions:

Drug Interactions:

P-glycoprotein (P-gp) substrates: Avoid concomitant use of ROMVIMZA with P-gp substrates. If concomitant use cannot be avoided, take ROMVIMZA at least 4 hours prior to P-gp substrates.
Breast Cancer Resistance Protein (BCRP) substrates: Avoid concomitant use of ROMVIMZA with BCRP substrates.
Organic Cation Transporter 2 (OCT2) substrates: Avoid concomitant use of ROMVIMZA with OCT2 substrates.
Concomitant use of vimseltinib with P-gp substrates, BCRP substrates or OCT2 substrates may increase exposure of these substrates.

Lactation: Advise females not to breastfeed during treatment with ROMVIMZA.

Please click for the full Prescribing Information.

Tumor response at Week 25 (6 months)1

Symptomatic and Functional Outcomes at Week 25 (6 months)1

The MOTION study included a patient population reflective of real‑world clinical experience—with the majority of study sites in Europe and North America1,2

Have additional questions?

Tumor response at Week 25 (6 months)¹

Symptomatic and Functional Outcomes at Week 25 (6 months)¹

The MOTION study included a patient population reflective of real‑world clinical experience—with the majority of study sites in Europe and North America^1,2