Noofambar 2021: Asciminib (Scemblix, Novartis AG) waxaa la siiyay ogolaansho degdeg ah Maamulka Cuntada iyo Dawooyinka ee bukaanada qaba Philadelphia chromosome-positive myeloid leukemia (Ph + CML) ee marxaladda daba-dheeraada (CP) kuwaas oo hore u helay laba ama in ka badan tyrosine kinase inhibitors (TKIs), iyo sidoo kale bukaanada qaangaarka ah. oo leh Ph+ CML oo ku jira CP kaasoo lahaa isu beddelka T315I.
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 waxaa lagu tijaabiyaa bukaanada qaba Ph + CML ee CP oo leh isbeddelka T315I ee CABL001X2101 (NCT02081378), xarun-badan, baaritaan caafimaad oo furan. Waxtarka asciminib 200 mg laba jeer maalin kasta 45 bukaan oo qaba isku-beddelka T315I ayaa la baaray. Bukaan-socodka ayaa lagu hayay daawaynta ilaa ay la kulmaan sunta aan loo dulqaadan karin ama daawaynta oo fashilantay. MMR waxay ahayd qiyaasta natiijada waxtarka aasaasiga ah. MMR waxaa lagu gaarey 42 boqolkiiba (19/45, 95 boqolkiiba kalsoonida: 28 ilaa 58 boqolkiiba) bukaannada 24 usbuuc ka dib. MMR waxaa lagu gaarey 49 boqolkiiba bukaanada (22/45, 95 boqolkiiba kalsoonida: 34 boqolkiiba ilaa 64 boqolkiiba) 96 usbuuc ka dib. Celceliska wakhtiga daawaynta waxa ay ahayd 108 todobaad (kala duwan, 2 ilaa 215 todobaad).
Caabuqyada hawada sare ee neef-mareenka, xanuunka murqaha, daalka, lallabbo, finan, iyo shuban ayaa ah waxyeelada ugu badan (20%). Tirada platelet-ka oo yaraada, triglycerides oo kordhay, tirada neutrophils oo yaraada iyo haemoglobin, iyo creatine kinase oo sareeya, alanine aminotransferase, lipase, iyo amylase ayaa ah cilladaha shaybaadhka ee ugu baahsan.
Bukaannada qaba Ph + CML ee CP kuwaas oo horay loogu daaweeyay laba ama in ka badan TKIs, qiyaasta asciminib ee lagu taliyey waa 80 mg oo afka laga bixiyo hal mar maalintii isla waqti isku mid ah maalin kasta ama 40 mg laba jeer maalintii qiyaastii 12-saacadood. Bukaannada qaba Ph + CML ee CP oo leh isbeddelka T315I, qiyaasta asciminib ee la soo jeediyay waa 200 mg laba jeer maalintii qiyaastii 12-saacadood.
