I te 5 o Poutū-te-rangi, 2025, i panuitia e Ascentage Pharma kua whakawhiwhia tā rātou rongoā, te olverembatinib, ki te Breakthrough Therapy Designation (BTD) e te Center for Drug Evaluation (CDE) o te National Medical Products Administration (NMPA) o Haina, hei whakamahi tahi me te chemotherapy iti-kaha mō te maimoatanga tuatahi o ngā tūroro hou kua tautuhia he mate pukupuku toto lymphoblastic acute (ALL) kei roto i te Philadelphia chromosome-positive (Ph+).
Koinei te tuatoru o ngā BTD i tukuna ki te olverembatinib i Haina, ko te BTD tuatahi i tukuna i te marama o Poutū-te-rangi 2021, mō te maimoatanga o ngā tūroro he mate pukupuku myeloid myeloid mau tonu (CML-CP) e ātete ana, e kore rānei e manawanui ki ngā aukati tyrosine kinase (TKI) o te whakatupuranga tuatahi me te tuarua; me te tuarua o ngā BTD i tukuna i te marama o Hune 2023, mō te maimoatanga o ngā tūroro he mate pukupuku stromal gastrointestinal (GIST) kāore i te whai hua i te succinate dehydrogenase (SDH) kua whiwhi maimoatanga raina tuatahi.
I pānuitia i te Hui-ā-Tau 66 o te American Society of Hematology (ASH) Te Haumaru me te Whai Huatanga o te Olverembatinib (HQP1351) i Whakakotahitia me te Lisaftoclax (APG-2575) i roto i ngā Tamariki me ngā Taiohi me te Relapsed/Refractory Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia (R/R Ph ALL): Pūrongo Tuatahi mai i tētahi Rangahau Wāhanga 1.
Ko te Olverembatinib, he TKI hou o te whakatupuranga tuatoru, he pai te manawanui, ā, he kaha, he roa hoki te mahi antileukemic i roto i ngā tāngata kua tino rongoatia te CP-CML me te kore rānei he whakarerekētanga T315I. Ko te lisaftoclax rangahau, he aukati BCL-2 hou, kua whakaatu i ngā painga antipuku haumanu i roto i ngā tāngata he maha ngā mate pukupuku toto. I tēnei wā, kāore he kōwhiringa maimoatanga whai hua e wātea ana mō ngā tāngata tamariki me te R/R Ph+ ALL. I hangaia tēnei rangahau hei tūhura i te haumaru, te whai huatanga, me te kōtaha pharmacokinetic (PK) o te olverembatinib anake, me te whakakotahi rānei me te lisaftoclax i roto i ngā tamariki me ngā taiohi me te R/R Ph ALL.+
He rangahau tuwhera tēnei, wāhanga 1b (NCT05495035) i whakaurua ai ngā tamariki me ngā taiohi <18 tau te pakeke me te R/R Ph ALL ātete, kāore rānei e manawanui ki te iti rawa o te kotahi te aukati tyrosine kinase (TKI) (kāore i whakaarohia te whakamahinga o mua o ngā TKI mēnā he whakarerekētanga T315I tō ngā tāngata). Me whai kaute tūnga mahi Karnofsky/Lansky me te mahi okana ngā tāngata. Kāore i whakaurua ngā tāngata me ngā mate pūnaha io matua e whakaatu ana i ngā tohu, ngā toto nui rānei, kāore e pā ana ki te PhALL. I tukuna ā-waha a Olverembatinib i te 40 mg horopeta ōrite pakeke (AED) i ia rā mō ngā wiki e 2 (Ngā Rā [R] 1-14), ā, i whai muri ko te horopeta kotahi o olverembatinib me te lisaftoclax i te horopeta kua tohua o te 200/400/600 mg (AED) ia rā (QD) i te D13-42 (i hiahiatia he whakanui horopeta 3-rā mai i te D13-15). I tukuna ā-waha te Dexamethasone 6 mg/m++ 2/rā QD mai i te D15-42. Ko ngā whāinga matua ko ngā aromatawai haumaru, te tere urupare whānui (ORR), te tere koretake o te mate toenga ine (MRD), me ngā āhuatanga PK o te olverembatinib anake/i te wā kotahi me te lisaftoclax.
Mai i te marama o Hepetema 2022 ki te marama o Hune 2024, e 10 ngā tohu i whakaurua. Ko te tau waenga (awhe) he 13.0 (11-15) tau, ā, e 6 ngā tohu he tāne. Ko te taumaha tinana waenga (awhe) he 49.85 (35.9-86.0) kg. E iwa (90.0%) ngā tohu i whakaatu i te tuhinga p190, ā, e 1 te tohu (10.0%) i whakaatu i te tuhinga p210. E toru ngā tohu i whai whakarerekētanga BCR-ABL1 [2, T315I; 1, F317L (c.951C>A)] i te tīmatanga. I muri i te whakamutua o te 1 pt i te whakamātautau nā te hopuhopu i runga i te D1 o te Akoranga 1 (C1D1), i whakaurua ngā pt whai mana e 9 ki te tauira whakanui horopeta 3+3 (n = 6, R/R; n = 3, kāore e manawanui): 3 ngā pt i ia Arm (A, B, me C) i ngā taumata horopeta lisaftoclax kua tohua o te 200, 400, me te 600 mg (AED), ia. I oti i ēnei pt te 42 rā o te maimoatanga, ā, i aromatawaihia mō ngā pito mutunga tuatahi. E ono o te 10 pt i pāngia e ngā pānga kino o te maimoatanga toto ≥ 3, tae atu ki te anemia (3/10), te neutropenia (7/10), me te thrombocytopenia (3/10); 1 pt i piki ake te alanine aminotransferase 3, ā, i mutu ai te maimoatanga, ā, 1 pt i hopuhopu i C1D1 (nāna i whakamutu te whakamātautau). I roto i ngā tohu e 6 i taea te arotake mō ngā urupare āhua, ko te ORR (whakakorenga katoa [CR] + CR me te whakahokinga mai o te tatau kāore i oti), te urupare hapa, me te kore urupare, ia, 2 (33.3%), 2 (33.3%), me te 2 (33.3%) i te mutunga o te olverembatinib monotherapy (EOM) me te 5 (83.3%), 0, me te 1 (16.7%) i te mutunga o te akoranga whakakotahitanga olverembatinib me te lisaftoclax (EOC). E rima o ngā tohu e 7 i taea te arotake i whiwhi i te MRD negative, 1 i roto i ēnei i te EOM me te 4 i te EOC. I whakaatuhia e ngā tātaritanga PK tuatahi he rite ngā āhuatanga PK me te whakaaturanga rite i waenga i ngā taupori tamariki me ngā pakeke mō te olverembatinib me te lisaftoclax. Kāore he kohikohinga nui i muri i ngā horopeta maha, ā, kāore i kitea he taunekeneke rongoā-rongoā i waenga i te olverembatinib me te lisaftoclax.
I whakaatuhia e ēnei raraunga tuatahi ko te olverembatinib me te lisaftoclax te āhua nei he tikanga haumaru, he tikanga whai hua hoki mō ngā tūroro e pāngia ana e te R/R Ph ALL. Nā tēnei tikanga i hua ake ai he reiti CR pai, me te kore he chemotherapy kaha, he immunotherapy rānei. Kei te wāhanga whakawhānui-horopeta te rangahau i tēnei wā.
I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.
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Ngā Tohutoro
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)
Wā tuku: Maehe-12-2025