Nuwamba 2021: Asciminib (Scemblix, Novartis AG) Cibiyar Abinci da Magunguna ta ba da izini ga marasa lafiya tare da Philadelphia chromosome-positive myeloid leukemia (Ph + CML) a cikin lokaci na yau da kullun (CP) wanda a baya ya karɓi masu hana tyrosine kinase inhibitors biyu ko fiye (TKIs), da kuma ga manya marasa lafiya. tare da Ph+ CML a cikin CP wanda ke da maye gurbin 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.
Ana gwada Asciminib a cikin marasa lafiya tare da Ph + CML a cikin CP tare da maye gurbin T315I a cikin CABL001X2101 (NCT02081378), cibiyar da yawa, binciken bincike na asibiti. An yi nazarin ingancin asciminib 200 MG sau biyu a rana a cikin marasa lafiya 45 tare da maye gurbin T315I. An ci gaba da kula da marasa lafiya har sai sun sami ciwon da ba za a iya jurewa ba ko gazawar jiyya. MMR shine ma'aunin sakamako na farko. An kai MMR a cikin kashi 42 cikin dari (19/45, kashi 95 cikin tazarar amincewa: kashi 28 zuwa kashi 58) na marasa lafiya bayan makonni 24. An kai MMR a cikin kashi 49 na marasa lafiya (22/45, kashi 95 cikin tazarar amincewa: kashi 34 zuwa kashi 64) bayan makonni 96. Matsakaicin lokacin jiyya shine makonni 108 (kewaye, makonni 2 zuwa 215).
Cututtukan da ke sama, ciwon tsoka, gajiya, tashin zuciya, kurji, da gudawa sune illar da suka fi yawa (20%). Rage kididdigar platelet, ƙara yawan triglycerides, rage yawan neutrophils da haemoglobin, da haɓakar creatine kinase, alanine aminotransferase, lipase, da amylase sune abubuwan da suka fi dacewa a cikin dakin gwaje-gwaje.
A cikin marasa lafiya tare da Ph + CML a cikin CP waɗanda aka yi amfani da su a baya tare da TKI biyu ko fiye, shawarar asciminib da aka ba da shawarar shine 80 MG da aka ba da baki sau ɗaya a rana a kusa da lokaci guda a kowace rana ko 40 MG sau biyu kowace rana a kusan 12-hour tazara. A cikin marasa lafiya tare da Ph + CML a cikin CP tare da maye gurbin T315I, adadin asciminib da aka ba da shawarar shine 200 MG sau biyu a rana a kusan sa'o'i 12.
