Ma ʻAukake 28, ua hoʻolaha ke Kikowaena no ka Loiloi Lāʻau Lapaʻau (CDE) o ka National Medical Products Administration (NMPA) ua manaʻo ʻia ʻo BL-B01D1 no ka inikini e hoʻokomo ʻia i loko o ke kaʻina hana loiloi koʻikoʻi. Ua manaʻo ʻia no nā poʻe maʻi me ka carcinoma nasopharyngeal recurrent a metastatic paha i mālama mua ʻia me nā antibodies monoclonal PD-1/PD-L1 a ua hāʻule ma ka liʻiliʻi ʻelua mau laina o ka chemotherapy (me ka liʻiliʻi hoʻokahi laina i loaʻa ka platinum).
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
ʻIkepili WeChat: 17801183037
Email：myimmnet@163.com
ʻO iza-bren kahi ADC mua loa i loko o ka papa i haku ʻia me kahi antibody bispecific EGFR x HER3 i hoʻopili ʻia i kahi payload inhibitor topo-I hou (Ed-04) ma o kahi linker cleavable paʻa i hoʻokumu ʻia i ka tetrapeptide. Hoʻopaʻa ka ʻano hana pālua o Iza-bren i nā hōʻailona EGFR a me HER3 i nā cell cancer, e hōʻemi ana i ka proliferation a me nā hōʻailona ola. Eia kekahi, ma hope o ka internalization antibody mediated, hoʻokuʻu ʻia ka payload therapeutic a iza-bren e hoʻoulu ai i ke kaumaha genotoxic e alakaʻi ai i ka make ʻana o nā cell cancer.
Ua hōʻike ʻia nā hopena o BL-B01D1 i nā poʻe maʻi me ka maʻi kanesa māmā non-small cell holomua kūloko a i ʻole metastatic (NSCLC) e hūnā ana i nā hoʻololi genomic hoʻokele (GA) ma waho o nā hoʻololi EGFR maʻamau i ka 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
Nā Hana: ʻO ka ʻāpana Phase Ib o kēia haʻawina i hoʻokomo i nā cohorts hoʻonui, kēlā me kēia i wehewehe ʻia e kahi GA i kuhikuhi mua ʻia, me nā hoʻokomo EGFR exon 20, nā hoʻololi EGFR non-classical, nā hoʻololi ma HER2, ALK, ROS1, BRAF (V600E a me nā mea ʻē aʻe), KRAS (G12C a me nā mea ʻē aʻe), SMARCA4, MET (Exon 14), RET, a me NTRK. Ua kākau inoa ʻia nā Pts me kēia GA i holomua ma nā ʻano lapaʻau i kuhikuhi ʻia maʻamau (inā loaʻa) a ʻaʻole i ʻoi aku ma mua o hoʻokahi laina mua o ka chemotherapy. Ua hāʻawi ʻia ʻo iza-bren ma 2.5 mg/kg D1D8 Q3W.
Nā Hualoaʻa: Ma ka lā 5 o Dekemaba, 2024, ua kākau inoa ʻia he 73 mau helu NSCLC me GA i helu ʻia. ʻElima mau helu e mālama ʻia ana, akā ua kāpae ʻia mai ka loiloi ma muli o ka lawa ʻole o ka hahai ʻana no ka scan mua ma hope o ke kumu (e nānā i ka papa ma lalo). Ma waena o 7 mau helu me nā hoʻokomo EGFR exon 20, 85.7% (6 mai 7) i loaʻa iā cPR. Ma waena o 8 mau helu me nā hoʻololi KRAS G12C, ua ʻike ʻia he 3 cPR a me 1 PR e kali ana i ka hōʻoia. E hōʻike ʻia ka pono no nā hui liʻiliʻi. ʻO nā TRAE hematologic pinepine loa (nā māka āpau) he anemia (87.7%), leukopenia (74.0%), thrombocytopenia (74.0%), a me neutropenia (72.6%); ʻO nā TRAE non-hematologic pinepine loa, ʻo ia ka asthenia (42.5%), ka nausea (41.1%), ka stomatitis (37.0%), ka diarrhea (32.9%), a me ka alopecia (31.5%). ʻO nā TRAE papa 3 a ʻoi aku hoʻi, he ʻano hematologic nui, ua hiki ke hoʻokele pono ʻia me ke ana kākoʻo maʻamau me ka hoʻemi ʻana i ka nui o ka lāʻau, e like me ka hōʻike ʻana a ka TRAE e alakaʻi ana i ka helu hoʻōki o 2.7%. Hoʻokahi wale nō hihia o G2 ILD i ʻike ʻia. ʻO ka mea nui, ʻaʻohe make e pili ana i ka iza-bren i hōʻike ʻia. ʻAʻohe hōʻailona palekana hou i ʻike ʻia.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
ʻIkepili WeChat: 17801183037
Email：myimmnet@163.com
Ka manawa hoʻouna: Sep-05-2025