A ranar 5 ga Maris, 2025, Ascentage Pharma ta sanar da cewa an ba wa maganinta, olverembatinib, sunanta na Breakthrough Therapy (BTD) daga Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kayayyakin Lafiya ta Kasa (NMPA), don haɗa shi da maganin chemotherapy mai ƙarancin ƙarfi don maganin farko ga sabbin marasa lafiya da aka gano suna da cutar sankarar lymphoblastic mai saurin kamuwa da cutar Philadelphia chromosome-positive (Ph+).
Wannan shine karo na uku da aka bai wa olverembatinib a China, tare da BTD na farko da aka bayar a watan Maris na 2021, don maganin marasa lafiya da ke fama da cutar sankarar myeloid ta lokaci-lokaci (CML-CP) mai jurewa da/ko rashin jurewa ga masu hana tyrosine kinase na ƙarni na farko da na biyu (TKIs); da kuma BTD na biyu da aka bayar a watan Yunin 2023, don maganin marasa lafiya da ke fama da cutar sankarar gastrointestinal stromal (GIST) mai ƙarancin succinate dehydrogenase (SDH) waɗanda suka sami maganin farko.
An sanar da shi a taron shekara-shekara na 66 na Ƙungiyar Nazarin Hematology ta Amurka (ASH) Tsaro da Ingancin Olverembatinib (HQP1351) tare da Lisaftoclax (APG-2575) a cikin Yara da Matasa masu fama da cutar sankarar lymphoblastic mai saurin kamuwa da cutar sankarar lymphosome mai saurin kamuwa da cutar sankarar lymphoblastic ...st mai saurin kamuwa da cutar sankarar huhu (R/R Ph ALL): Rahoton Farko daga Nazarin Mataki na 1.
Olverembatinib, wani sabon nau'in TKI na ƙarni na uku, yana da juriya sosai kuma yana da ƙarfi da juriya wajen hana cutar sankarar bargo a cikin marasa lafiya da ke fama da CP-CML da aka riga aka yi musu magani tare da ko ba tare da maye gurbin T315I ba. Lisaftoclax na bincike, sabon mai hana BCL-2, ya nuna fa'idodin maganin ƙari a cikin marasa lafiya da ke fama da cutar kansa da yawa. A halin yanzu, babu wasu hanyoyin magani masu tasiri da ake da su ga marasa lafiya da ke fama da R/R Ph+ ALL. An tsara wannan binciken ne don bincika aminci, inganci, da kuma bayanin pharmacokinetic (PK) na olverembatinib kaɗai ko tare da lisaftoclax a cikin yara da matasa da ke fama da R/R Ph ALL.+
Wannan wani bincike ne na mataki na 1b (NCT05495035) wanda ya yi rajistar yara da matasa 'yan ƙasa da shekaru 18 waɗanda ke da R/R Ph ALL mai juriya ko rashin jure wa aƙalla 1 tyrosine kinase inhibitor (TKI) (ba a yi la'akari da amfani da TKIs a baya ba idan pts suna da maye gurbi na T315I). An buƙaci Pts su sami isasshen maki na aikin Karnofsky/Lansky da aikin gabobi. An cire Pts masu alamun rashin lafiya na tsarin jijiyoyi na tsakiya ko zubar jini mai yawa, waɗanda ba su da alaƙa da PhALL. An ba Olverembatinib baki a kashi 40 MG na babba daidai da allurar (AED) kowace rana na tsawon makonni 2 (Kwanaki [D] 1-14), sannan aka bi da shi da kashi ɗaya na olverembatinib tare da lisaftoclax a kashi da aka ba da na 200/400/600 mg (AED) kowace rana (QD) akan D13-42 (ana buƙatar ƙaruwar allurar kwanaki 3 daga D13-15). An ba Dexamethasone 6 mg/m++ a kowace rana 2/rana ta hanyar QD daga D15-42. Manyan abubuwan da aka gano sun haɗa da kimantawa kan aminci, ƙimar amsawar gabaɗaya (ORR), ƙimar rashin lafiyar da ake iya aunawa (MRD), da halayen PK na olverembatinib kaɗai/tare da lisaftoclax.
Daga Satumba 2022 zuwa Yuni 2024, jimillar maki 10 aka yi rijista. Matsakaicin shekarun (tsakanin) shine shekaru 13.0 (11-15), kuma maki 6 maza ne. Matsakaicin nauyin jiki (tsakanin) shine kilogiram 49.85 (35.9-86.0). maki tara (90.0%) sun bayyana rubutun p190 kuma maki 1 (10.0%) sun bayyana rubutun p210. maki uku sun sami maye gurbi na BCR-ABL1 [2, T315I; 1, F317L (c.951C>A)] a farkon. Bayan an dakatar da gwajin sau 1 saboda kamuwa da cutar D1 na Darasi na 1 (C1D1), an haɗa maki 9 da suka cancanta a cikin samfurin ƙaruwar allurai na 3+3 (n = 6, R/R; n = 3, rashin haƙuri): maki 3 a kowace Hannu (A, B, da C) a matakan allurai na lisaftoclax da aka ƙayyade na 200, 400, da 600 MG (AED), bi da bi. Waɗannan maki sun kammala kwanaki 42 na magani kuma an tantance su don manyan maki. Shida daga cikin maki 10 sun fuskanci maki ≥ 3 na maganin jini - abubuwan da suka faru marasa kyau, gami da anemia (3/10), neutropenia (7/10), da thrombocytopenia (3/10); maki 1 yana da ƙaruwar alanine aminotransferase na mataki na 3 wanda ya haifar da dakatar da magani, kuma maki 1 ya sami suma a C1D1 (wanda ya dakatar da gwajin). Daga cikin maki 6 da aka kimanta don amsoshin siffa, ORR (cikakken gafara [CR] + CR tare da murmurewa daga ƙididdigewa ba tare da cikakke ba), amsawar ɓangare, kuma babu ƙimar amsawa, bi da bi, 2 (33.3%), 2 (33.3%), da 2 (33.3%) a ƙarshen olverembatinib monotherapy (EOM) da 5 (83.3%), 0, da 1 (16.7%) a ƙarshen kwas ɗin haɗin olverembatinib da lisaftoclax (EOC). Biyar daga cikin maki 7 masu kimantawa sun sami mummunan sakamako na MRD, wanda 1 ya kasance a EOM da 4 a EOC. Binciken farko na PK ya nuna halaye iri ɗaya na PK da kuma kamuwa da juna tsakanin yara da manya don olverembatinib da lisaftoclax. Babu wani tarin abubuwa masu yawa bayan allurai da yawa, kuma ba a lura da hulɗar miyagun ƙwayoyi da miyagun ƙwayoyi tsakanin olverembatinib da lisaftoclax ba.
Waɗannan bayanai na farko sun nuna cewa olverembatinib tare da lisaftoclax ya bayyana a matsayin magani mai aminci da tasiri ga marasa lafiya da ke fama da R/R Ph ALL. Wannan magani ya haifar da kyakkyawan ƙimar CR ba tare da maganin chemotherapy mai tsanani ko maganin rigakafi ba. Binciken a halin yanzu yana cikin matakin faɗaɗa allurai.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Nassoshi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.发现和开发一流的小分子癌症疗法的领导者 - (ascentage.com)
Lokacin Saƙo: Maris-12-2025