Romvimza (vimseltinib) / Ono Pharma - LARVOL DELTA

EFFICACY WITH VIMSELTINIB IN PATIENTS (PTS) WITH TENOSYNOVIAL GIANT CELL TUMOR (TGCT) AND PRIOR COLONY-STIMULATING FACTOR 1 (CSF1) INHIBITOR THERAPY: A PHASE 2 CASE SERIES (CTOS 2025) - P1/2 | "Here, we report efficacy with vimseltinib in pts with prior pexidartinib or vimseltinib treatment. Pts with symptomatic TGCT not amenable to surgery were enrolled in this multicenter, open-label, phase 1/2 trial. These results suggest that pts with TGCT not amenable to surgery can derive clinical benefit from resumption of anti-CSF1R therapy, even after discontinuing the same (vimseltinib) or a different inhibitor. Vimseltinib retreatment was well tolerated with a manageable safety profile, consistent with prior reports."

P2 data • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor • CSF1

EFFECT OF A HIGH-FAT MEAL ON THE PHARMACOKINETICS (PK) OF VIMSELTINIB, AN ORAL INHIBITOR OF THE COLONY-STIMULATING FACTOR 1 RECEPTOR (CSF1R), IN HEALTHY PARTICIPANTS (CTOS 2025) - P3 | "The 90% CIs for the GMRs of vimseltinib AUC0–tlast and AUC0–inf fell within the equivalence limits of 80% to 125%, indicating that administration of vimseltinib with a high-fat meal did not affect vimseltinib PK. Vimseltinib was well tolerated, and safety was consistent with prior reports. These results provide the basis for the approved labeling instruction that vimseltinib may be taken with or without food."

PK/PD data • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

MEDICAL MANAGEMENT OF TENOSYNOVIAL GIANT CELL TUMOR (CTOS 2025) - "Multiple colony-stimulating factor 1 receptor inhibitors (CSF1Ris) have emerged for symptomatic pts, with pexidartinib (pexi) and vimseltinib (vim) approved. Here, we review phase 3 reports for pexi, vim, and pimicotinib (pimi). PubMed was searched for publications associated with TGCT, CSF-1Ri, therapies for treatment of TGCT, and known guidelines, with a focus on phase 3 trials and postmarket analyses... CSF1Ris show efficacy in TGCT. Pts should be monitored for potential side effects that are different for each presented drug. Further research to understand long-term side effects and duration of response will be paramount to optimize therapeutic strategies for pts with TGCT."

Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

LONG-TERM EFFICACY AND SAFETY OF VIMSELTINIB IN PATIENTS (PTS) WITH TENOSYNOVIAL GIANT CELL TUMOR (TGCT): RESULTS FROM THE MOTION PHASE 3 TRIAL (CTOS 2025) - No abstract available

Clinical • P3 data • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

EFFECT OF ITRACONAZOLE (ITZ) AND RABEPRAZOLE (RBP) ON THE PHARMACOKINETICS (PK) OF VIMSELTINIB, AN ORAL INHIBITOR OF THE COLONY-STIMULATING FACTOR 1 RECEPTOR, IN HEALTHY PARTICIPANTS (CTOS 2025) - "P-gp inhibition with ITZ and gastric acid suppression with RBP had weak effects on total vimseltinib exposure and absorption, respectively. Neither treatment affected the safety profile. Overall, the DDI for vimseltinib with ITZ or with RBP was not considered clinically significant, providing basis for approved concomitant use of vimseltinib with P-gp inhibitors and PPIs.Plasma PK Parameters of Vimseltinib by Treatment"

PK/PD data • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

Deciphera Announces Multiple Data Presentations at the Connective Tissue Oncology Society (CTOS) Annual Meeting 2025 (Businesswire) - "Multiple presentations on vimseltinib for the treatment of Tenosynovial Giant Cell Tumor (TGCT), including encore data from the Phase 3 MOTION study presented in an oral session; Two posters on DCC-3009 in Gastrointestinal Stromal Tumor (GIST)."

Clinical data • Gastrointestinal Stromal Tumor • Tenosynovial Giant Cell Tumor

Health-Related Quality of Life Measured by EQ-5D Utility Among Patients With TGCT: A Trial-Based Analysis of EQ-5D Data From Patients in the MOTION Trial (ISPOR-EU 2025) - P3 | "TGCT patients not amenable for surgery in the MOTION trial had poor HRQoL at baseline (0.53) comparable to other pain-ridden diseases, such as osteoarthritis or multiple sclerosis. Based on MOTION, vimseltinib significantly improves PF and worst pain NRS over time, leading to large gains in HRQoL. These results fill a gap in describing HRQoL for TGCT patients not amenable for surgery and will support modeling the changes expected in EQ-5D due to changes in key symptoms of TGCT for health technology assessment."

Clinical • HEOR • CNS Disorders • Giant Cell Tumor of Bone • Immunology • Multiple Sclerosis • Osteoarthritis • Rheumatology • Tenosynovial Giant Cell Tumor

Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2) (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Deciphera Pharmaceuticals, LLC | Not yet recruiting ➔ Recruiting

Enrollment open

"Long-term efficacy and safety of vimseltinib in patients with tenosynovial giant cell tumor (TGCT): 2-year results from the MOTION phase 3 trial" (DGHO 2025) - P3 | "In these 2-year results from the MOTION phase 3 trial, vimseltinib continued to demonstrate robust and durable antitumor efficacy with a well-tolerated safety profile that was consistent with prior reports. These long-term results support vimseltinib as a treatment option for patients with TGCT not amenable to surgery, where it is approved. Abstract will be presented at ESMO 2025 in Berlin, Germany."

Clinical • P3 data • Giant Cell Tumor of Bone • Oncology • Solid Tumor • Tenosynovial Giant Cell Tumor • CSF1R

Long-term clinical outcome assessments (COAs) in patients (pts) with tenosynovial giant cell tumor (TGCT) treated with vimseltinib: 1-year results from the MOTION phase 3 trial (DGHO 2025) - P3 | "These 1-year COA results from the MOTION phase 3 trial demonstrate durable and continued improvements in active ROM, physical function, stiffness, health status, and pain with ongoing vimseltinib treatment. Continued treatment with vimseltinib provides clinically meaningful benefit in functional health and QoL beyond week 25 for pts with symptomatic TGCT whose disease is not amenable to surgery. Abstract will be presented at ASCO 2025."

Clinical • Clinical data • P3 data • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor • CSF1R

Long-term efficacy and safety of vimseltinib in patients (pts) with tenosynovial giant cell tumor (TGCT): 2-year results from the MOTION phase III trial (ESMO 2025) - P3 | "Conclusions In these 2-year results from the MOTION phase 3 trial, vimseltinib continued to demonstrate robust and durable antitumor efficacy with a well-tolerated safety profile that was consistent with prior reports. These long-term results support vimseltinib as a treatment option for pts with TGCT not amenable to surgery, where it is approved."

Clinical • P3 data • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor • CSF1R

A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD) (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Deciphera Pharmaceuticals, LLC | N=36 ➔ 48

Enrollment change • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Evaluate the Effect of Vimseltinib on the Pharmacokinetics of a BCRP and OATP1B1 Substrate (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Deciphera Pharmaceuticals, LLC | Not yet recruiting ➔ Recruiting

Enrollment open

Deciphera Presents 2-Year Efficacy and Safety Results from MOTION Phase 3 Study of ROMVIMZA (vimseltinib) in Patients with Tenosynovial Giant Cell Tumor (TGCT) at the European Society for Medical Oncology Congress 2025 (Businesswire) - "In these two-year results from the MOTION Phase 3 trial, vimseltinib continued to demonstrate robust and durable antitumor efficacy with a manageable safety profile that was consistent with prior reports...Of 83 patients randomized to vimseltinib in Part 1, 73 continued open-label treatment in Part 2. Median (range) treatment duration was 23.6 months (2 to 36)...ORR on study per RECIST v1.1 was 48% (40/83) for patients randomized to vimseltinib and 54% (19/35) for those who crossed over to vimseltinib."

P3 data • Tenosynovial Giant Cell Tumor

Deciphera Receives European Commission Approval of ROMVIMZA (vimseltinib) for the Treatment of Tenosynovial Giant Cell Tumor (TGCT) (Businesswire) - "The EC approval is supported by compelling efficacy and safety results from the pivotal Phase 3 MOTION study of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed), compared to placebo, as well as the Phase 1/2 study of vimseltinib."

EMA approval • Tenosynovial Giant Cell Tumor

Study of DCC-3014 in Combination With Avelumab in Patients With Advanced or Metastatic Sarcomas (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Memorial Sloan Kettering Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Aug 2025 | Trial primary completion date: Jan 2026 ➔ Aug 2025

Trial completion • Trial completion date • Trial primary completion date • Leiomyosarcoma • Liposarcoma • Oncology • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2) (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Deciphera Pharmaceuticals, LLC

New P1 trial

Evaluate the Effect of Vimseltinib on the Pharmacokinetics of a BCRP and OATP1B1 Substrate (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Deciphera Pharmaceuticals, LLC

New P1 trial

Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: Deciphera Pharmaceuticals, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • Giant Cell Tumor of Bone • Tenosynovial Giant Cell Tumor

A phase I study of the CSF1R inhibitor vimseltinib in combination with the PD-L1 inhibitor avelumab in patients with advanced sarcoma. (PubMed, ESMO Open) - "Vimseltinib plus avelumab was generally safe and well tolerated. This combination had minimal clinical efficacy in our population of heavily pretreated patients with sarcoma."

Journal • P1 data • Oncology • Sarcoma • Solid Tumor

Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib (clinicaltrials.gov) - P=N/A | N=100 | Not yet recruiting | Sponsor: Deciphera Pharmaceuticals, LLC

New trial • Real-world evidence • Giant Cell Tumor of Bone • Tenosynovial Giant Cell Tumor

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2025 (European Medicines Agency) - "On 24 July 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Romvimza, intended for the treatment of adults with symptomatic tenosynovial giant cell tumour (TGCT). The applicant for this medicinal product is Deciphera Pharmaceuticals (Netherlands) B.V....Romvimza is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability."

CHMP • Tenosynovial Giant Cell Tumor

Onco360 Has Been Selected as a National Specialty Pharmacy Partner for ROMVIMZA (vimseltinib) (GlobeNewswire) - "Onco360, the nation’s leading independent specialty pharmacy, has been selected as a specialty pharmacy partner by Deciphera Pharmaceuticals, LLC for ROMVIMZA (vimseltinib), which has been approved by the U.S. Food and Drug Administration for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. This indication was approved based on the Phase III MOTION study of ROMVIMZA in patients with tenosynovial giant cell tumor (TGCT)."

Commercial • Tenosynovial Giant Cell Tumor

Vimseltinib: A novel colony stimulating factor 1 receptor (CSF1R) inhibitor approved for treatment of tenosynovial giant cell tumors (TGCTs). (PubMed, Intractable Rare Dis Res) - "As the second-in-class CSF1R inhibitor approved for TGCTs, vimseltinib exhibits enhanced selectivity for CSF1R over pexidartinib, the first-in-class agent, suggesting potential translational benefits in safety profiles. The clinical utility of vimseltinib is anticipated to be further elucidated by real-world evidence and expanded clinical evaluations."

Journal • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

Long-term clinical outcome assessments in patients with tenosynovial giant cell tumor treated with vimseltinib: 1-year results from the MOTION phase 3 trial. (ASCO 2025) - P3 | "These 1-year COA results from the MOTION phase 3 trial demonstrate durable and continued improvements in active ROM, physical function, stiffness, health status, and pain with ongoing vimseltinib treatment. Continued treatment with vimseltinib provides clinically meaningful benefit in functional health and QoL beyond week 25 for patients with symptomatic TGCT whose disease is not amenable to surgery."

Clinical • Clinical data • P3 data • Giant Cell Tumor of Bone • Oncology • Pain • Tenosynovial Giant Cell Tumor • CSF1R