Rezurock (belumosudil) / Romeck Pharma, Sanofi 
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  • ||||||||||  FDA event, Journal:  FDA-approved therapies for chronic GVHD. (Pubmed Central) -  Jan 12, 2025   
    In the last ten years, the drugs ibrutinib, ruxolitinib, belumosudil and axatilimab were FDA-approved for cGVHD. Here we discuss which signaling pathways and cell types are targeted, the clinical studies that were the basis for FDA-approval, and future directions for clinical research.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Incyte
    Avascular Necrosis (AVN) Outcomes in Allogeneic Stem Cell Transplant Recipients () -  Dec 7, 2024 - Abstract #ASH2024ASH_9442;    
    Time to onset of AVN was calculated in years, with high-dose steroids defined as prednisone 60mg/day or higher...For GVHD prophylaxis, 75% of the patients received Tacrolimus /Methotrexate, 16% post-transplant Cytoxan (PTCy)-MMF-Tacrolimus, and 9% other prophylaxis...40% of these patients had full clinical mobility post-surgery.At 3 months post-op, 18% used steroids, 8.9% ruxolitinib, 0.81% belumosudil...Surgical management is an important treatment option, and our data highlights that even for patients with ongoing GVHD, the 3 months post op survival was 100%. While efficacy may be variable, joint replacement appears to be a safe modality and should be considered for all alloHCT recipients with AVN.
  • ||||||||||  Jakafi (ruxolitinib) / Incyte
    Ruxolitinib Resistance or Intolerance in Steroid-Refractory Chronic Graft-Versus-Host Disease - a Real-World Single Center Analysis () -  Dec 7, 2024 - Abstract #ASH2024ASH_9373;    
    AML was the most common transplant indication (n = 24), 68% patients underwent marrow ablative conditioning and 96% (n = 45) patients received tacrolimus and methotrexate for GVHD prophylaxis...After ruxolitinib failure/intolerance, the three most common next line agents used were belumsoudil (51%), ECP (30%) and on trial axatilimab (4.5%)...Median duration on ECP was 466.5 (95% CI : [167, Not reached]) days.11 (25.6%) patients continued ruxolitinib while initiating 3rd line therapy of which 6 were concurrently on ECP (ORR 67%, 1 CR, 3 PR, 1 Stable disease [SD], 1 PD) while 3 were on belumosudil (ORR 67%, 2 PR, 1 SD).Conclusion : cGVHD remains a significant problem, with patients requiring therapy after ruxolitinib. Third line therapy provides modest benefit with responses in 38.5% of patients, creating potential for new drug development or utilizing current drugs as combinations for improved outcomes.
  • ||||||||||  Changes in Immunosuppressive Treatment of Chronic Graft-Versus-Host Disease: Results from a Survey within Allogeneic Hematopoietic Stem Cell Transplant Centers in Germany, Austria, and Switzerland () -  Dec 7, 2024 - Abstract #ASH2024ASH_9361;    
    In case of new sclerotic manifestations after failure of 2nd line treatment including steroids, CNI and rux, most centers would use ECP (13/19), whereas subsequent or alternative salvage treatment of sclerotic manifestations remains heterogenous comprising belumosudil (12/19), ibrutinib (5/19), imatinib (5/19), rituximab (4/19), cyclosporine (3/19), tacrolimus (3/19), everolimus (3/19), sirolimus (3/19), MTX (3/19) and MMF (3/19)...ECP is used in case of contraindication for rux and both agents are also used in progressive onset cGVHD. In contrast, treatment of BOS and sclerotic cGvHD remains heterogeneous after failure of 2nd-line treatment with new agents being integrated in the treatment landscape.
  • ||||||||||  Review, Journal:  Contemporary Updates in the Prevention and Treatment of Graft-Versus-Host Disease. (Pubmed Central) -  Nov 17, 2024   
    Combinations with novel agents such as itolizumab appear promising for high risk acute GVHD...For chronic GVHD requiring therapy beyond steroids, ruxolitinib, belumosudil, and ibrutinib are now available and should be considered. Increasingly, GVHD has become a manageable complication after allogeneic HCT potentially translating to greater success with allogeneic HCT in the future.
  • ||||||||||  Extracorporeal Photopheresis (ECP) in the Era of New Chronic Graft-Versus-Disease (GVHD) Therapies (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_3260;    
    There was no difference in 3 year OS (81.5 vs 83.4%), DFS ( 73% vs 78%), Relapse ( 16% vs 13%) and NRM (13% vs 10%), p=NS for ECP and no ECP groups. In conclusion, our data shows that ECP alone or in combination with other treatments is highly effective treatment for chronic GVHD with comparable responses and higher reduction in GVHD total symptom score compared to non-ECP modalities.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    Journal:  Neural network analysis as a novel skin outcome in a trial of belumosudil in patients with systemic sclerosis. (Pubmed Central) -  Nov 1, 2024   
    Fibrosis Score changes correlated with histologic feature changes ( e.g. , hyalinized collagen, SC fat loss) that were distinct from those associated with mRSS changes ( e.g. , telangiectasia, perivascular CD3+, and % of CD8?+?among CD3+). These data suggest that AI applied to SSc biopsies may be useful for quantifying pathologic features of SSc beyond skin thickness.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Incyte, Imbruvica (ibrutinib) / AbbVie, J&J
    Review, Journal:  Multidisciplinary Management of Morbidities Associated with Chronic Graft-Versus-Host Disease. (Pubmed Central) -  Oct 29, 2024   
    This review highlights the myriad impacts of cGVHD, including and beyond the traditional organ systems captured by the National Institutes of Health Consensus Criteria, including iatrogenic complications of long-term immunosuppression. It presents the implications of cGVHD and its treatment on cardiovascular and metabolic health, bone density, endocrine function, sexual health, and ocular and pulmonary disease and outlines a framework around the comprehensive multidisciplinary approach for its evaluation and management.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi, Jakafi (ruxolitinib) / Incyte, Imbruvica (ibrutinib) / AbbVie, J&J
    Review, Journal:  Oral Chronic Graft-Versus-Host Disease: Pathogenesis, Diagnosis, Current Treatment, and Emerging Therapies. (Pubmed Central) -  Oct 16, 2024   
    This review synthesizes current knowledge on the pathogenesis, diagnosis and management of oral cGVHD, with a focus on emerging trends and novel therapeutics. Data from various clinical studies and expert consensus are integrated to provide a comprehensive overview.
  • ||||||||||  Tysabri (natalizumab) / Biogen, Royalty, Rezurock (belumosudil) / Romeck Pharma, Sanofi, Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
    Refractory encephalitis as an atypical manifestation of chronic graft-versus-host disease (Singapore; In-Person) -  Oct 13, 2024 - Abstract #DGHO2024DGHO_1028;    
    A 25 year-old male patient received alloSCT for severe aplastic anemia after non-myeloablative conditioning including 2 Gy total body irradiation and GvHD prophylaxis with ATG, cyclosporine and MMF...Steroid taper during the following weeks resulted in progression of neurological symptoms but rotation to natalizumab induced complete remission of cGvHD...Re-initiation of fingolimod did not control the CNS disease and axatilimab (0.3mg/kg every 2 nd week) was started within a compassionate use program...Due to neurological deterioration, belumosudil was added however without any effect. This case instructively demonstrates core features of atypical CNS cGvHD I) initial diagnosis is frequently a diagnosis of exclusion with decent findings such as mild CNS fluid pleocytosis and response to immunosuppression; II) cMRI findings suggest that CNS GvHD follows the clinical course of classic cGvHD (inflammation, dysregulation and subsequent fibrosis); III) cGvHD can be highly treatment resistant in selected cases.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi, Vistide (cidofovir) / Gilead
    A Case of Unresolving Hypokalemia () -  Oct 12, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_5184;    
    She also has acyclovir resistant HSV rectal lesions for which she was on cidofovir-stopped 08/13, restarted on 1/2024 then stopped again on 2/17/2024.Pt has long Hx of hypokalemia since 2014...She was placed on maximum oral and IV potassium of total around 160 Meq with amiloride which only raised potassium to 3.4...Literature previously reported hypokalemia post BMT, SCT but by themselves they are amenable to oral and may need temporary IV management. Antiretroviral induced Fanconi has been rarely noted previously.This case shows that:1-Hypokalemia can be refractory when multifactorial and certain pathologies have additive effects.2-Full treatment is sometimes difficult as therapy ends up being too radical for Pt..
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    Journal:  Therapeutic modulation of ROCK overcomes metabolic adaptation of cancer cells to OXPHOS inhibition and drives synergistic anti-tumor activity. (Pubmed Central) -  Sep 30, 2024   
    We validate these results by orthogonal genetic and pharmacologic approaches by demonstrating that KD025 (Belumosudil), an FDA approved ROCK inhibitor, has highly synergistic anti-cancer activity in vitro and in vivo in combination with OXPHOS inhibition...Importantly, we found converging phosphorylation-dependent regulatory cross-talk by AMPK and ROCK kinases on key RHO GTPase signaling/ROCK-dependent substrates such as PPP1R12A, NUMA1 and PKMYT1 that are known regulators of cell cycle progression. Taken together, our study identified ROCK kinases as critical mediators of metabolic adaptation of cancer cells to OXPHOS inhibition and provides a strong rationale for pursuing ROCK inhibitors as novel combination partners to OXPHOS inhibitors in cancer treatment.
  • ||||||||||  Review, Journal:  Current Approaches for the Prevention and Treatment of Acute and Chronic GVHD. (Pubmed Central) -  Sep 27, 2024   
    Bronchiolitis obliterans syndrome (BOS) still represents a challenge; among the compounds targeting non-immune effectors, Alvelestat, a Neutrophil elastase inhibitor, seems promising in BOS. Finally, in both aGVHD and cGVHD, the association of biological markers with specific disease manifestations could help refine risk stratification and the availability of reliable biomarkers for specific treatments.
  • ||||||||||  Sarclisa (isatuximab-irfc) / Sanofi
    Enrollment change, Combination therapy:  Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov) -  Sep 27, 2024   
    P1/2,  N=258, Recruiting, 
    Finally, in both aGVHD and cGVHD, the association of biological markers with specific disease manifestations could help refine risk stratification and the availability of reliable biomarkers for specific treatments. N=197 --> 258
  • ||||||||||  Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
    CSF-1R Inhibitor (Axatilimab) for Chronic GVHD (Room B (2F)) -  Sep 24, 2024 - Abstract #ICBMT2024ICBMT_186;    
    Responses were not influenced by the extent of cGVHD involvement at baseline organ, number of received prior lines of treatment (including use of ruxolitinib, ibrutinib or belumosudil), and were seen across all organs, including sclerotic manifestation such as joints and fascia, esophagus, lung, and skin. Targeting CSF-1R
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    New Chapter of cGvHD Therapeutics: Belumosudil (Room B (2F)) -  Sep 24, 2024 - Abstract #ICBMT2024ICBMT_36;    
    Also, I will share preliminary efficacy data of Belumosudil with respect to its response rate, clinical benefit and failure-free survival (FFS) for cGvHD treatment, which has become available in Canada since March 2023 under the compassionate program. Also, I will discuss the newer clinical CTTC guideline of cGvHD management 2024 which includes not only Canadian consensus of clinical management of cGvHD patients, but also further development of future therapeutics incorporating a novel agent with 4 major directions: 1) a mode-of-action-based cGvHD drug selection, according to the pathogenesis/clinical manifestation of cGvHD, (2) a combination strategy with the introduction of newer targeted drugs, (3) a steroid-free regimen, particularly for front line therapy for cGvHD treatment, and (4) a pre-emptive approach which can prevent the progression of cGvHD in high-risk patients destined to develop severe and highly morbid forms of cGvHD.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    Journal:  Discovery of novel pyrazolo[1,5-a]pyrimidine derivatives as selective ROCK2 inhibitors with anti-breast cancer migration and invasion activities. (Pubmed Central) -  Aug 31, 2024   
    Herein, based on Belumosudil, a series of pyrazolo[1,5-a]pyrimidine derivatives as selective ROCK2 inhibitors were designed and synthesized...Furthermore, cell scratch and transwell assays indicated that 7u inhibited MDA-MB-231 cell migration and invasion in a dose-dependent manner. Ultimately, the binding model of 7u with ROCK2 well accounted for the superior activities of 7u as a promising ROCK2 inhibitor with the potential application in breast cancer metastasis treatment.
  • ||||||||||  Rezurock (belumosudil) / Romeck Pharma, Sanofi
    Trial completion date, Trial primary completion date:  BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) (clinicaltrials.gov) -  Jun 13, 2024   
    P2,  N=45, Recruiting, 
    In summary, belumosudil 200?mg once daily as second or subsequent LOT in Japanese patients with steroid-dependent/steroid-resistant cGVHD was effective, with no new safety concerns. Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Jun 2026