Olverembatinib yahawe uburyo bwo kuvura indwara ya kanseri y’amaraso ya Lymphoblastic ifata chromosome ya Philadelphia (Ph+) (ALL)

Ku ya 5 Werurwe 2025, Ascentage Pharma yatangaje ko umuti wayo, olverembatinib, wemerewe Breakthrough Therapy Designation (BTD) n'Ikigo gishinzwe Isuzuma ry'Imiti (CDE) cy'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi mu Bushinwa (NMPA), kubera ko uvanze na chemotherapy yoroheje mu kuvura abarwayi baherutse gupimwa indwara ya Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

Iyi ni yo miti ya gatatu ya BTD yahawe olverembatinib mu Bushinwa, aho BTD ya mbere yahawe muri Werurwe 2021, yo kuvura abarwayi bafite kanseri y’imitsi idakira (CML-CP) idakira cyangwa itihanganira imiti igabanya ubukana bwa tyrosine kinase inhibitors (TKIs) yo mu gisekuru cya mbere n’icya kabiri; naho BTD ya kabiri yahawe muri Kamena 2023, yo kuvura abarwayi bafite kanseri y’imitsi idakira ya succinate dehydrogenase (SDH) (GIST) yari yarahawe ubuvuzi bwa mbere.

Byatangajwe mu nama ngarukamwaka ya 66 y’Umuryango w’Abanyamerika w’Ubuvuzi bw’Amazi (ASH) Umutekano n’Ingufu za Olverembatinib (HQP1351) bivanze na Lisaftoclax (APG-2575) ku bana n’ingimbi bafite Leukemia ya Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia (R/R Ph ALL): Raporo ya mbere y’ubushakashatsi bw’icyiciro cya mbere.

Olverembatinib, ubwoko bushya bwa TKI bwo mu gisekuru cya gatatu, yihanganirwa neza kandi ikora neza mu kurwanya ukemike mu ma pts afite CP-CML yavuwe mbere cyane hamwe n’impinduka za T315I cyangwa idafite. Lisaftoclax y’ubushakashatsi, umuti mushya wo gukumira BCL-2, yagaragaje akamaro ko kurwanya kanseri mu ma pts afite kanseri nyinshi zo mu maraso. Kuri ubu, nta buryo bwiza bwo kuvura abana bafite R/R Ph+ ALL. Ubu bushakashatsi bwakozwe kugira ngo busuzume umutekano, imikorere, n’imiterere ya pharmacokinetic (PK) ya olverembatinib yonyine cyangwa ivanze na lisaftoclax mu bana n’ingimbi bafite R/R Ph ALL.

Ubu bushakashatsi bwakozwe mu cyiciro cya 1b (NCT05495035) bwakozwe ku bana n'ingimbi bafite imyaka iri munsi ya 18 bafite R/R Ph ALL irwanya cyangwa itihanganira nibura 1 tyrosine kinase inhibitor (TKI) (gukoresha mbere TKIs ntibyari byitezwe niba pts zari zifite T315I mutation). Pts zasabwaga kugira amanota ahagije y'imikorere ya Karnofsky/Lansky n'imikorere y'ingingo. Pts zifite ibimenyetso by'indwara z'imitsi yo hagati cyangwa kuva amaraso menshi, bitari bifitanye isano na PhaLL, ntizakuwemo. Olverembatinib yatanzwe mu kanwa ku gipimo kingana na 40 mg ku muntu mukuru (AED) buri munsi mu gihe cy'ibyumweru 2 (Iminsi [D] 1-14), hagakurikiraho igipimo kimwe cya olverembatinib hamwe na lisaftoclax ku gipimo cyagenwe cya 200/400/600 mg (AED) buri munsi (QD) kuri D13-42 (hakenewe kongera igipimo cy'iminsi 3 kuva kuri D13-15). Dexamethasone 6 mg/m++ 2/umunsi yatanzwe mu kanwa QD kuva kuri D15-42. Ingingo z'ibanze zavuyemo zari zirimo gusuzuma umutekano, igipimo rusange cyo gusubiza (ORR), igipimo cy'indwara zisigara (MRD) negativity rate), hamwe n'imiterere ya PK ya olverembatinib yonyine/hamwe na lisaftoclax.

Kuva muri Nzeri 2022 kugeza muri Kamena 2024, handitswe abantu 10 bose hamwe. Imyaka y’ubukure yari hagati ya 13.0 (11-15), naho abagabo 6 bari abagabo. Uburemere bw’umubiri bwari 49.85 (35.9-86.0) kg. Imyaka icyenda (90.0%) yagaragaje inyandiko ya p190 naho 1 (10.0%) igaragaza inyandiko ya p210. Imyaka itatu yari ifite impinduka za BCR-ABL1 [2, T315I; 1, F317L (c.951C>A)] mu ntangiriro. Nyuma y’uko 1 pt ihagaritswe mu igeragezwa kubera ifatwa ry’imitsi ku gipimo cya D1 cy’icyiciro cya 1 (C1D1), 9 pt zujuje ibisabwa zashyizwe mu cyiciro cya 3 + 3 (n = 6, R/R; n = 3, idashobora kwihanganira): 3 pt muri buri kuboko (A, B, na C) ku gipimo cya lisaftoclax cya 200, 400, na 600 mg (AED) cyagenwe, uko bikurikirana. Izi pt zarangije iminsi 42 y’ubuvuzi kandi zapimwe ingingo z’ibanze. 6 muri 10 pt zagize ingaruka mbi ku buvuzi bw’amaraso mu rwego rwa ≥ 3, harimo kubura amaraso (3/10), neutropenia (7/10), na thrombocytopenia (3/10); 1 pt yagize ubwiyongere bwa alanine aminotransferase mu rwego rwa 3 byatumye ihagarika kuvurwa, naho 1 pt yagize ifatwa ry’imitsi ku gipimo cya C1D1 (wahagaritse igeragezwa). Mu madosiye 6 yapimwe ku bisubizo bya morphologic, ORR (kugarukira burundu [CR] + CR hamwe no kugaruka kw'umubare utuzuye), igisubizo cy'igice, hamwe n'igipimo cy'ibisubizo, uko bikurikirana, 2 (33.3%), 2 (33.3%), na 2 (33.3%) mu mpera ya olverembatinib monotherapy (EOM) na 5 (83.3%), 0, na 1 (16.7%) mu mpera ya olverembatinib na lisaftoclax combination course (EOC). Eshanu muri 7 zapimwe zagize MRD negativity, muri zo 1 yari kuri EOM na 4 kuri EOC. Isesengura rya mbere rya PK ryagaragaje imiterere isa ya PK n'itandukaniro riri hagati y'abana n'abantu bakuru kuri olverembatinib na lisaftoclax. Nta kwiyongera gukomeye kwabayeho nyuma yo gufata dose nyinshi, kandi nta mibanire y'imiti n'imiti yagaragaye hagati ya olverembatinib na lisaftoclax.

Aya makuru y’ibanze yagaragaje ko olverembatinib hamwe na lisaftoclax isa nkaho ari gahunda yizewe kandi ifite akamaro ku barwayi bafite R/R Ph ALL. Iyi gahunda yatumye habaho igipimo cyiza cya CR kidasaba imiti ivura indwara nyinshi cyangwa immunotherapy. Ubu bushakashatsi buri mu cyiciro cyo kongera igipimo.

Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.

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Amareferensi

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)

3.Inyandiko: Umutekano n'Ingufu za Olverembatinib (HQP1351) Bivanze na Lisaftoclax (APG-2575) ku Bana n'Ingimbi bafite Leukemia ya Relapsed/Refractory ya Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia (R/R Ph ⁺ ALL): Raporo ya Mbere y'Inyigo y'Icyiciro cya 1 (confex.com)