Mbudzi 2021: Asciminib (Scemblix, Novartis AG) yakapihwa yakakurumidza kubvumidzwa neChikafu neDrug Administration kune varwere vane Philadelphia chromosome-positive chronic myeloid leukemia (Ph + CML) muchirwere chisingaperi (CP) avo vakambogamuchira maviri kana anopfuura tyrosine kinase inhibitors (TKIs), pamwe nevarwere vakuru. nePh+ CML muCP aive neT315I mutation.
ASCEMBL (NCT03106779) is a multi-center, randomised, active-controlled, open-label clinical trial investigating asciminib in patients with Ph+ CML in CP who have had two or more TKIs before. A total of 233 patients were randomly assigned (2:1) to receive either asciminib 40 mg twice daily or bosutinib 500 mg once daily, based on their significant cytogenetic response (MCyR) status. Patients were kept on treatment until they experienced intolerable toxicity or treatment failure. At 24 weeks, the main efficacy outcome measure was the major molecular response (MMR). The MMR rate in patients treated with asciminib was 25% (95 percent CI: 19, 33) compared to 13% (95 percent CI: 6.5, 23; p=0.029) in those treated with bosutinib. The median length of MMR has not yet been attained, with a median follow-up of 20 months.
Asciminib iri kuedzwa muvarwere vane Ph+ CML muCP ine T315I mutation muCABL001X2101 (NCT02081378), yakawanda-center, yakavhurika-label kiriniki yekuferefeta. Kubudirira kweasciminib 200 mg kaviri zuva nezuva muvarwere ve45 vane T315I mutation yakadzidzwa. Varwere vaichengetwa pakurapa kusvika vasangana nehuturu husingagoneki kana kutadza kurapwa. MMR ndiyo yaive yekutanga mhedzisiro chiyero. MMR yakasvika mu42 muzana (19/45, 95 muzana yekuvimba nguva: 28 muzana kusvika 58 muzana) yevarwere mushure memavhiki makumi maviri nemana. MMR yakasvikwa mu24 muzana yevarwere (49/22, 45 muzana yekuvimba nguva: 95 muzana kusvika 34 muzana) mushure memavhiki makumi mapfumbamwe nematanhatu. Ivhareji yenguva yekurapa yaiva mavhiki e64 (renji, 96 kusvika kumavhiki e108).
Zvirwere zvepamusoro zvekufema, kurwadziwa kwemusculoskeletal, kuneta, kusvotwa, kuputika, uye manyoka ndizvo zvinonyanya kuitika (20%). Kuderera kweplatelet count, kuwedzera triglycerides, kuderera kweneutrophil count uye haemoglobin, uye kukwidziridza creatine kinase, alanine aminotransferase, lipase, uye amylase ndizvo zvinonyanya kutekeshera murabhoritari.
Mune varwere vane Ph + CML muCP avo vakambobatwa neTKI mbiri kana kupfuura, iyo yakakurudzirwa asciminib dose ndeye 80 mg inobatwa nemuromo kamwe chete zuva panguva yakapoteredza nguva imwe chete zuva rega rega kana 40 mg kaviri zuva nezuva panguva dzinenge 12-awa. Muvarwere vane Ph+ CML muCP ine T315I mutation, iyo yakakurudzirwa asciminib dose ndeye 200 mg kaviri pazuva panguva dzinenge 12-awa.
