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12 Trials |  |
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- || Sarclisa (isatuximab-irfc) / Sanofi
Trial completion date, Trial primary completion date, Combination therapy: Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov) - May 27, 2024
P1/2, N=197, Recruiting, Sponsor: Sanofi
Trial completion date: Dec 2027 --> Mar 2028 | Trial primary completion date: Dec 2027 --> Jun 2027
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi, Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi
Enrollment closed, Immunomodulating: Immunological Tolerance in Patients With Mismatched Kidney Transplants (clinicaltrials.gov) - May 23, 2024
P1, N=16, Active, not recruiting, Sponsor: University of California, Los Angeles
Trial completion date: Dec 2027 --> Mar 2028 | Trial primary completion date: Dec 2027 --> Jun 2027 Recruiting --> Active, not recruiting
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Journal: PCDH17 restricts dendritic spine morphogenesis by regulating ROCK2-dependent control of the actin cytoskeleton, modulating emotional behavior. (Pubmed Central) - May 15, 2024
Inhibition of ROCK2 activity with belumosudil (KD025) ameliorates the defective F-actin organization and spine structure induced by PCDH17 overexpression, suggesting that ROCK2 mediates the effects of PCDH17 on F-actin content and spine development. Hence, these findings reveal a novel mechanism by which PCDH17 regulates synapse development and behavior, providing pathological insights into the neurobiological basis of mood disorders.
- ||||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
New P2 trial: Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy (EUDRACT) - Apr 30, 2024
P2, N=270, , Sponsor: Kadmon Corporation, LLC
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
Clinical efficacy of belumosudil in cutaneous chronic graft-versus-host disease (Trinity Exhibit Hall) - Apr 27, 2024 - Abstract #SID2024SID_763;
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
Treatment of chronic graft-versus-host disease with combination extracorporeal photopheresis and the ROCK2 inhibitor belumosudil can reverse sclerodermatous changes (Trinity Exhibit Hall) - Apr 27, 2024 - Abstract #SID2024SID_166;
- || Rezurock (belumosudil) / Romeck Pharma, Sanofi
P1 data, Journal: Two-Part Phase 1 Study to Evaluate the Taste Profile of Novel Belumosudil Oral Suspensions and Assess the Relative Bioavailability and Food Effect of the Selected Belumosudil Oral Suspension Compared With Oral Tablet Reference in Healthy Male Participants. (Pubmed Central) - Apr 24, 2024
P1
Safety and tolerability were consistent with the known safety profile of belumosudil. These results may support administration of a 200-mg belumosudil oral suspension with or without food.
- ||| Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Incyte, Imbruvica (ibrutinib) / AbbVie, J&J
Clinical guideline, Journal: ERS/EBMT clinical practice guideline on treatment of pulmonary chronic graft-versus-host disease in adults. (Pubmed Central) - Apr 1, 2024
Following the ERS standardised methodology, we conducted systematic reviews to address these questions and used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to develop recommendations.The resulting guideline addresses common therapeutic options (inhalation therapy, fluticasone-azithromycin-montelukast, imatinib, ibrutinib, ruxolitinib, belumosudil, extracorporeal photopheresis and lung transplantation), as well as other aspects of general management, such as lung functional and radiological follow-up and pulmonary rehabilitation, for adults with pulmonary cGvHD phenotype bronchiolitis obliterans syndrome. These recommendations include important advancements that could be incorporated in the management of adults with pulmonary cGvHD, primarily aimed at improving and standardising treatment and improving outcomes.
- || Rezurock (belumosudil) / Romeck Pharma, Sanofi
P2 data, Clinical Trial,Phase II, Journal: A phase II study of belumosudil for chronic graft-versus-host disease in patients who failed at least one line of systemic therapy in China. (Pubmed Central) - Mar 31, 2024
P2
These recommendations include important advancements that could be incorporated in the management of adults with pulmonary cGvHD, primarily aimed at improving and standardising treatment and improving outcomes. Belumosudil treatment demonstrated a favorable benefit-risk balance in treating cGVHD patients who previously have had standard corticosteroid therapy in China where approved second-line setting is absent.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
ARTIFICIAL INTELLIGENCE (DEEP NEURAL NETWORK ANALYSIS) AS A SKIN OUTCOME: RESULTS OF AN OPEN-LABEL BELUMOSUDIL TRIAL IN PATIENTS WITH DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS (Poster View) - Mar 29, 2024 - Abstract #EULAR2024EULAR_1680;
Belumosudil treatment was associated with non-clinically important mRSS improvement that mirrored decreases in telangiectasia, perivascular CD3+, and % CD8+ among CD3+ cells. The weak correlation between mRSS and DNN-Fibrosis Score contrasted with our previous findings that we attribute to batch effects from staining protocols between our published and our current analysis which may be overcome with analyses of larger cohorts.
- || Rezurock (belumosudil) / Romeck Pharma, Sanofi, Rituxan (rituximab) / Roche
Enrollment open: Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease (clinicaltrials.gov) - Mar 12, 2024
P2, N=25, Recruiting, Sponsor: Northside Hospital, Inc.
The weak correlation between mRSS and DNN-Fibrosis Score contrasted with our previous findings that we attribute to batch effects from staining protocols between our published and our current analysis which may be overcome with analyses of larger cohorts. Not yet recruiting --> Recruiting
- Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Novartis, Incyte, Imbruvica (ibrutinib) / AbbVie, J&J
207 - REACHing for ROCKstars - Updates in Chronic Graft Versus Host Disease (Ballroom D) - Feb 27, 2024 - Abstract #HOPA2024HOPA_54;
Additionally, a brief review of novel agents and studies that are in process or case studies that have been completed will be reviewed. The focus of the presentation will be on interventions that pharmacists can make while treating cGVHD and clinical pearls for currently approved options.Learning Objectives:
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
Pulmonary Chronic GVHD Manifesting as Photograph Negative Pulmonary Edema (San Diego Convention Center, Area D (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_6223;
He had a history of skin, gastrointestinal and ocular cGVHD, for which he was prescribed belumosudil with adequate disease control...Glucocorticoids are first line for treatment, followed by immune modulating therapies such as JAK inhibitors or serine/threonine kinase inhibitors. Prompt identification of pulmonary cGVHD is essential to impacting the course of this disease, which includes the recognition of ILDs as part of the spectrum of postallogeneic HSCT complications.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
SAFETY AND EFFICACY OF THE ROCK2-INHIBITOR BELUMOSUDIL IN CGVHD TREATMENT (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_2505;
In summary, belumosudil was well tolerated and induced a remarkable response in a heavily pretreated cohort of cGvHD patients within a real-world setting. Further prospective trials are needed to determine the duration of response and the impact on GvHD-related mortality.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
SAFETY AND EFFICACY OF THE ROCK2-INHIBITOR BELUMOSUDIL IN CGVHD TREATMENT (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_2504;
In summary, belumosudil was well tolerated and induced a remarkable response in a heavily pretreated cohort of cGvHD patients within a real-world setting. Further prospective trials are needed to determine the duration of response and the impact on GvHD-related mortality.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
EFFECTOR SITE IMMUNE DYNAMICS IN REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE: A ROCKSTAR TRIAL COMPANION STUDY AFTER BELUMOSUDIL TREATMENT (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1386;
P2
Further prospective trials are needed to determine the duration of response and the impact on GvHD-related mortality. After 6 months of belumosudil treatment in patients with oral cGVHD, there were significant dose and tissue-specific decreases in collagen levels and in IL-17 in the oral mucosa along with key salivary cytokine levels, suggesting a ROCK2 inhibition-induced reduction in tissue fibrosis and inflammation in the oral cavity
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
EFFECTOR SITE IMMUNE DYNAMICS IN REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE: A ROCKSTAR TRIAL COMPANION STUDY AFTER BELUMOSUDIL TREATMENT (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1385;
P2
After 6 months of belumosudil treatment in patients with oral cGVHD, there were significant dose and tissue-specific decreases in collagen levels and in IL-17 in the oral mucosa along with key salivary cytokine levels, suggesting a ROCK2 inhibition-induced reduction in tissue fibrosis and inflammation in the oral cavity After 6 months of belumosudil treatment in patients with oral cGVHD, there were significant dose and tissue-specific decreases in collagen levels and in IL-17 in the oral mucosa along with key salivary cytokine levels, suggesting a ROCK2 inhibition-induced reduction in tissue fibrosis and inflammation in the oral cavity
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
BELUMOSUDIL PHASE 1 DOSE-ESCALATION STUDY IN HEALTHY VOLUNTEERS AND PHASE 2 STUDY IN PATIENTS WITH CGVHD WHO FAILED ?1 LINE OF SYSTEMIC THERAPY IN CHINA (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1039;
P2
Single dose belumosudil is safe and well-tolerated in healthy Chinese population, with a PK profile similar to global studies. Belumosudil also demonstrated a favorable benefit
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
BELUMOSUDIL PHASE 1 DOSE-ESCALATION STUDY IN HEALTHY VOLUNTEERS AND PHASE 2 STUDY IN PATIENTS WITH CGVHD WHO FAILED ?1 LINE OF SYSTEMIC THERAPY IN CHINA (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1038;
P2
Single dose belumosudil is safe and well-tolerated in healthy Chinese population, with a PK profile similar to global studies. Belumosudil also demonstrated a favorable benefit
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
BELUMOSUDIL FOR SEVERE, REFRACTORY CHRONIC GVHD IN PEDIATRIC PATIENT: CASE REPORT (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1037;
Belumosudil also demonstrated a favorable benefit At that moment patient was given rituximab with no clinical improvement...Lung GvHD was diagnosed and he started with methotrexate and steroid therapy
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
BELUMOSUDIL FOR CHRONIC GRAFT-VERSUS-HOST DISEASE AFTER ?2 PRIOR LINES OF SYSTEMIC THERAPY: 3-YEAR FOLLOW-UP OF THE ROCKSTAR STUDY (Hall 5) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1036;
P2
At that moment patient was given rituximab with no clinical improvement...Lung GvHD was diagnosed and he started with methotrexate and steroid therapy At baseline, the median age of participants was 55 years (range: 21
- Jakafi (ruxolitinib) / Novartis, Incyte
A SERIES OF STEROID-REFRACTORY, SEVERE CHRONIC GRAFT- VERSUS- HOST DISEASE CASES, TREATED WITH RUXOLITINIB- A SINGLE-CENTER EXPERIENCES (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_850;
Marked clinical improvement in the symptoms from the GI tract was observed, without impact on radiological features. Combined treatment of bronchiolitis obliterans with RUXO and belumosudil did not succeed.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
COMPARING DEEP NEURAL NETWORK ANALYSIS TO MODIFIED RODNAN SKIN SCORE IN A TRIAL OF BELUMOSUDIL FOR SYSTEMIC SCLEROSIS PATIENTS (Forum Hall) - Feb 13, 2024 - Abstract #SSWC2024SSWC_476;
DNN Fibrosis Scores tended to be lower for participants with higher mRSS (>25). We attribute this divergence to batch effects from staining protocols and may be overcome with analyses of larger cohorts.
- || Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Novartis, Incyte
Review, Journal: Prophylaxis and management of graft-versus-host disease after stem-cell transplantation for haematological malignancies: updated consensus recommendations of the European Society for Blood and Marrow Transplantation. (Pubmed Central) - Feb 5, 2024
The EBMT proposes to use these recommendations as the basis for routine management of GVHD during allogenic HSCT. The current recommendations favour European practice and do not necessarily represent global preferences.
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment open, Trial initiation date: Phase I/II Open Label Study of Belumosudil Mesylate Alone, and in Combination With Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - Jan 31, 2024
P1/2, N=36, Recruiting, Sponsor: M.D. Anderson Cancer Center
The current recommendations favour European practice and do not necessarily represent global preferences. Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Jan 2024
- || Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment open: BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) (clinicaltrials.gov) - Jan 17, 2024
P2, N=45, Recruiting, Sponsor: Dana-Farber Cancer Institute
Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Jan 2024 Not yet recruiting --> Recruiting
- || FDA event, Review, Journal: Cost in the United States of FDA-approved small molecule protein kinase inhibitors used in the treatment of neoplastic and non-neoplastic diseases. (Pubmed Central) - Jan 15, 2024
There is a negative correlation of the cost of the drugs and the incidence of the targeted disease. Many of these agents are or were designated as orphan drugs meaning that there are fewer than 200,000 potential patients in the United States.
- ||||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
Trial termination: ROCKstar: Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy (clinicaltrials.gov) - Dec 21, 2023
P2, N=159, Terminated, Sponsor: Kadmon, a Sanofi Company
Active, not recruiting --> Terminated; The sponsor has decided to prematurely terminate the study due to the challenges encountered in recruiting adolescent participants. This decision was made without any safety concerns.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Novartis, Incyte
Combination Ruxolitinib and Belumosudil Is Tolerable and Induces Responses Despite Treatment Failure As Monotherapies () - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_1057;
The combination is tolerable, may be utilized after failure of both as monotherapies with excellent response, delays the need for alternative therapies, and facilitates tapering of corticosteroids. Continued analysis is warranted to assess durability of response, though there may be overlapping downstream effects of STAT3 and STAT5.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
Single Pediatric Transplant Center Experience with Belumosudil As a Potential Treatment for Chronic Graft Vs Host Disease in Adolescents and Young Adults () - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_1052;
Here we describe one of the largest collection of adolescent and young adults treated at a pediatric transplant center showing that Belumosudil is potentially an effective and safe treatment for adolescents and young adults with cGVHD including those with liver involvement and those on other drugs for anti-fungal and relapse prophylaxis. Further pediatric studies are required to establish long term safety and efficacy including potential biomarker studies.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Novartis, Incyte
Combined Belumosudil-Ruxolitinib Therapy for the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease (cGVHD) Was Associated with Robust Treatment Response and Was Well-Tolerated () - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_1050;
Our findings suggest that treatment combination with drugs that have a distinct mechanism of action is feasible and possibly synergistic. Nonetheless, a large prospective study is needed to determine the role of drug combination in cGVHD.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
Real-World Experience Study of Belumosudil in Steroid-Refractory Chronic Graft-Versus-Host Disease (cGVHD) Demonstrated High Treatment Response without Significant Toxicities () - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_1044;
Treatment was overall well tolerated, and toxicity-related therapy discontinuation did not occur. Our real-world study indicates a similar experience to the clinical trial and supports the use of belumosudil in SR/SD cGVHD.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
Effector Site Immune Dynamics in Refractory Chronic Graft-Versus-Host Disease: A Rockstar Trial Companion Study after Belumosudil Treatment. () - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_1032;
Our real-world study indicates a similar experience to the clinical trial and supports the use of belumosudil in SR/SD cGVHD. After 6 months of belumosudil treatment in patients with skin and oral cGVHD, there was a significant dose-dependent and tissue-specific decrease in collagen levels and reduction in IL-17 and TGF-beta-1 cytokine levels, suggesting a ROCK2 inhibition-induced reduction in tissue fibrosis, as marked by collagen content, and inflammation.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Novartis, Incyte
Use of a Tissue-Targeting Recombinant Human Interleukin-22 Fusion Molecule (F-652) for the Treatment of Advanced Refractory Lower GI Acute Gvhd () - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_1023;
Whereas most GVHD treatments involve immunosuppresion, IL-22 acts on epithelial cells where it can support tissue recovery, improve barrier function, and promote innate antimicrobial immunity. CRP elevations post-treatment suggest that IL-22 may be able to exert such effects even with concurrent ruxolitinib.
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
Belumosudil for Chronic Graft-Versus-Host Disease after 2 or More Prior Lines of Systemic Therapy: 3-Year Follow-up of the Rockstar Study () - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_1021;
P2
In this 3-year follow-up study, patients continued to show a good response to belumosudil with no new safety concerns. FFS was 44.1% (41.6% in the 200-mg QD arm and 46.7% in the 200-mg BID arm) at 3 years for all patients and 51.8% (49.1% in the 200-mg QD arm and 54.4% in the 200-mg BID arm) for responders, showing good control of cGVHD and long-term tolerability.
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Novartis, Incyte
Journal: Belumosudil and ruxolitinib combination for treatment of refractory chronic graft-versus-host disease. (Pubmed Central) - Dec 10, 2023
FFS was 44.1% (41.6% in the 200-mg QD arm and 46.7% in the 200-mg BID arm) at 3 years for all patients and 51.8% (49.1% in the 200-mg QD arm and 54.4% in the 200-mg BID arm) for responders, showing good control of cGVHD and long-term tolerability. No abstract available
- ||| Sarclisa (isatuximab-irfc) / Sanofi
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov) - Dec 7, 2023
P1/2, N=197, Recruiting, Sponsor: Sanofi
No abstract available N=123 --> 197 | Trial completion date: Nov 2028 --> Dec 2027 | Trial primary completion date: Nov 2028 --> Dec 2027
- axatilimab (SNDX-6352) / Syndax Pharma, Incyte
Safety and Efficacy of Axatilimab in Patients with Chronic Graft-Versus-Host Disease (AGAVE-201) (Stars at Night B1 (Ballroom Level, Henry B. Gonzalez Convention Center); in-person) - Dec 5, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_675;
P2
N=123 --> 197 | Trial completion date: Nov 2028 --> Dec 2027 | Trial primary completion date: Nov 2028 --> Dec 2027 The ORR (95% CI) by Cycle 7 was 73.8% (62.7
- || Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment closed, Trial completion date, Trial primary completion date: ROCKstar: Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy (clinicaltrials.gov) - Nov 29, 2023
P2, N=159, Active, not recruiting, Sponsor: Kadmon, a Sanofi Company
The ORR (95% CI) by Cycle 7 was 73.8% (62.7 Recruiting --> Active, not recruiting | Trial completion date: Jan 2026 --> Dec 2023 | Trial primary completion date: Jan 2026 --> Dec 2023
- || Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment open: Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Male and Female Participants Aged 12 Years and Above With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy (clinicaltrials.gov) - Nov 27, 2023
P2, N=36, Recruiting, Sponsor: Kadmon, a Sanofi Company
Recruiting --> Active, not recruiting | Trial completion date: Jan 2026 --> Dec 2023 | Trial primary completion date: Jan 2026 --> Dec 2023 Not yet recruiting --> Recruiting
- |||||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment open, Combination therapy: ROCKnrol-1: A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease. (clinicaltrials.gov) - Nov 26, 2023
P3, N=240, Recruiting, Sponsor: Sanofi
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
New P3 trial, Combination therapy: ROCKnrol-1: A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease. (clinicaltrials.gov) - Nov 22, 2023
P3, N=240, Not yet recruiting, Sponsor: Sanofi
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
Journal: DeFilipp Z, Kim HT, Yang Z, et (Pubmed Central) - Nov 21, 2023
Not yet recruiting --> Recruiting No abstract available
- || Rezurock (belumosudil) / Romeck Pharma, Sanofi
Review, Journal: Unraveling the rationale and conducting a comprehensive assessment of KD025 (Belumosudil) as a candidate drug for inhibiting adipogenic differentiation-a systematic review. (Pubmed Central) - Nov 15, 2023
No abstract available Additionally, KD025 resulted in the suppression of fatty acid-binding protein 4 (FABP4 or AP2) expression, a
- ||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment open: Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease (clinicaltrials.gov) - Nov 3, 2023
P2, N=82, Recruiting, Sponsor: Fred Hutchinson Cancer Center
Additionally, KD025 resulted in the suppression of fatty acid-binding protein 4 (FABP4 or AP2) expression, a Not yet recruiting --> Recruiting
- Rezurock (belumosudil) / Romeck Pharma, Sanofi
Inhibition of Rho-Associated Coiled-Coil Containing Protein Kinases with Belumosudil Mesylate Shows Anti-Tumor and Immune Modulatory Properties in Models of Multiple Myeloma (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6140;
Studies of myeloma resistance mechanisms showed belumosudil largely overcame adhesion-mediated drug resistance, and was active against MM.1S and RPMI 8226 cells that are considered daratumumab-resistant. Moreover, belumosudil showed equal or even, in some cases, higher potency against bortezomib-, carfilzomib-, dexamethasone-, iberdomide-, lenalidomide-, melphalan-, and mezigdomide-resistant cell lines compared to their drug-na
- axatilimab (SNDX-6352) / Syndax Pharma, Incyte
Safety and Efficacy of Axatilimab at 3 Different Doses in Patients with Chronic Graft-Versus-Host Disease (AGAVE-201) (SDCC - Hall A) - Nov 3, 2023 - Abstract #ASH2023ASH_3215;
P1/2, P2
Axatilimab treatment of refractory cGVHD in heavily pretreated patients resulted in robust clinical activity and durable responses in all 3 dose cohorts, with the highest ORR and least toxicity at the 0.3 mg/kg Q2W dose. Adverse events consisted primarily of transient laboratory abnormalities and other on-target effects known to be associated with CSF-1R block.
- | Rezurock (belumosudil) / Romeck Pharma, Sanofi
New P1/2 trial: Phase I/II Open Label Study of Belumosudil Mesylate Alone, and in Combination With Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - Oct 27, 2023
P1/2, N=36, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
- |||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
Enrollment open: ROCKaspire: A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction (clinicaltrials.gov) - Oct 15, 2023
P3, N=180, Recruiting, Sponsor: Sanofi
Adverse events consisted primarily of transient laboratory abnormalities and other on-target effects known to be associated with CSF-1R block. Not yet recruiting --> Recruiting
- |||||||| Rezurock (belumosudil) / Romeck Pharma, Sanofi
New P3 trial: ROCKaspire: A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction (clinicaltrials.gov) - Oct 13, 2023
P3, N=180, Not yet recruiting, Sponsor: Sanofi