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甲磺酸贝舒地尔片治疗慢性移植物抗宿主病的临床疗效？
Marketing information
On August 3, 2023, the official website of the China National Medical Products Administration showed that the marketing application for ROCK2 inhibitors submitted by Yehui Pharmaceuticals has been approved, and the approved indication is the treatment of chronic graft-versus-host disease (cGVHD).
In addition to being listed in China, it is also listed in the United States, Japan, EU member states, the United Kingdom, Canada, France, Germany and other countries. In July 2021, besudil mesylate tablets were approved for the first time in the United States for the treatment of adult and pediatric patients with cGVHD aged ≥ 12 years who have received at least two previous systemic therapies.
What is chronic graft-versus-host disease
Chronic graft-versus-host disease (cGVHD) is a common complication after allogeneic hematopoietic stem cell transplantation. It can affect multiple organ systems of patients, including skin, mouth, eyes, joints, liver, lungs, esophagus and gastrointestinal tract, leading to inflammation, fibrosis and dysfunction. In severe cases, it can lead to transplant failure, disease recurrence and even death.
Clinical advantages of Besudil Mesylate Tablets in the treatment of chronic graft-versus-host disease
1. Targeted treatment: Besudil Mesylate Tablets targets the key signaling pathway of Rho-associated coiled-coil protein kinase 2 (ROCK2), which can regulate immune responses, reduce inflammation and fibrosis processes, and plays an important role in improving symptoms and organ functions of patients with cGVHD.
2. Significant efficacy: Clinical research data show that Besudil mesylate tablets have a high overall response rate in the treatment of cGVHD, with a relatively high 6-month failure-free survival rate and 2-year overall survival rate.
3. Good safety: Compared with traditional treatment methods, Besudil mesylate tablets, as a targeted therapy drug, have better safety and can reduce the side effects caused by long-term use of hormones.
4. Improve the quality of life: cGVHD has a serious impact on the health and quality of life of patients. Besudil mesylate tablets can control the development of the disease and help improve the quality of life of patients.
Clinical use of besudil mesylate tablets in the treatment of chronic graft-versus-host disease
A phase 2 randomized multicenter registration study evaluated besudil mesylate tablets 200 mg daily (n=66) and 200 mg twice daily (n=66) in subjects with cGVHD who had received 2=5 prior treatment series, with an overall median follow-up of 14 months.
The best ORRs for besudil mesylate tablets 200 mg daily and 200 mg twice daily were 74% and 77%, respectively. High response rates were observed in all subgroups, and all affected organs showed complete responses. The median DOR was 54 weeks.
44% of subjects received treatment for ≥1 year, and 59% and 62% reported symptom relief after taking 200 mg besudil mesylate tablets daily and 200 mg besudil mesylate tablets twice daily. Adverse events (AEs) were consistent with those expected in patients with cGVHD receiving corticosteroids and other immunosuppressants. Besudil mesylate tablets are a promising drug for the treatment of cGVHD, with good tolerability and clinically meaningful responses.
In a randomized, open-label, multi-center pivotal clinical trial called ROCKstar, a total of 65 patients received besudil mesylate tablets. The trial results showed that the overall response rate (ORR) of patients in the besudil mesylate tablets treatment group was 75%, the complete response rate was 6%, and the median time required for the first remission was 1.8 months. 62% of patients who achieved remission did not need to use new systemic therapies for at least 12 months after remission, and the median duration of remission was 1.9 months.
Dosage
The recommended dose is 200 mg once daily until progression of chronic GVHD requiring new systemic therapy. This medicine needs to be swallowed whole. Do not cut, crush, or chew the tablets.
The specification of a box of Besudil mesylate tablets is 200mg*30 tablets. The current reference price on the market is about $216,750 per box.
References:
Cutler C, Lee SJ, Arai S, Rotta M, Zoghi B, Lazaryan A, Ramakrishnan A, DeFilipp Z, Salhotra A, Chai-Ho W, Mehta R, Wang T, Arora M, Pusic I, Saad A, Shah NN, Abhyankar S, Bachier C, Galvin J, Im A, Langston A, Liesveld J, Juckett M, Logan A, Schachter L, Alavi A, Howard D, Waksal HW, Ryan J, Eiznhamer D, Aggarwal SK, Ieyoub J, Schueller O, Green L, Yang Z, Krenz H, Jagasia M, Blazar BR, Pavletic S. Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar Study. Blood. 2021 Dec 2;138(22):2278-2289. doi: 10.1182/blood.2021012021. Erratum in: Blood. 2022 Mar 17;139(11):1772. PMID: 34265047; PMCID: PMC8641099.
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