Nov 2021: Asciminib (Scemblix, Novartis AG) Approbatio accelerata data est a Cibus et medicamentis Administrationis aegris cum Philadelphia chromoso-positivis longis myeloideis leukemia (Ph+CML) in periodo chronica (CP) qui prius duos vel plures kinasum tyrosinum inhibitores (TKIs), ac pro aegris adultis accepit cum Ph+ CML in CP qui mutationem T315I habuit.
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 temptatur in patientibus cum Ph+ CML in CP cum mutatione T315I in CABL001X2101 (NCT02081378), inquisitio multi-media, pittacium clinicum apertum. Efficacia asciminib 200 mg bis cotidie in 45 aegris cum T315I mutationem studuit. Aegroti in curatione servabantur donec intolerabilem toxicitatem aut defectum curationis experti sunt. MMR exitus primarius efficaciae fuit mensura. MMR perventum est in 42 centesimis (19/45, 95 centesimis fiduciae interstitium: 28 percent ad 58 centesimas) aegrorum post 24 septimanas. MMR perventum est in 49 centesimas aegrorum (22/45, 95 percent fiduciae interstitium: 34 percent ad 64 centesimas) post 96 septimanas. Mediocris curatio tempus erat 108 hebdomades (range, 2 ad 215 septimanas).
Tractus respiratorii superioris infectiones, dolor musculoskeletalis, lassitudo, nausea, temeritas, et diarrhoea sunt effectus lateris praevalentes (20%). Comites bracteae minuti, triglycerides auctae, neutrophili comitum haemoglobinorum minuuntur, et kinasum creatinum, alaninum aminotransferasum, lipasium et amylasium crebrae abnormitates laboratoriae sunt.
Aegris cum Ph+ CML in CP, qui antea duobus vel pluribus TKIs curatus est, asciminiba dosis 80 mg semel ore ministratur, semel eodem die vel circa idem tempus singulis diebus vel 40 mg bis cottidie circa intervalla 12-horarum. Aegris cum Ph+ CML in CP mutatis T315I, dosis asciminib suggessit 200 mg bis die circiter horarum XII intervallis.
