I te 28 o Ākuhata, i panuitia e te Center for Drug Assessment (CDE) o te National Medical Products Administration (NMPA) kua whakaarohia kia whakaurua te BL-B01D1 mō te werohanga ki roto i te tukanga arotake matua. He mea hanga tēnei mō ngā tūroro he mate pukupuku nasopharyngeal e hokihoki mai ana, e horapa ana rānei, kua rongoatia i mua ki ngā paturopi monoclonal PD-1/PD-L1, ā, kua rahua i te iti rawa e rua ngā raina chemotherapy (me te iti rawa kotahi te raina kei roto te platinum).
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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Ko Iza-bren te ADC tuatahi o te karaehe e titoa ana i tētahi paturopi EGFR x HER3 bispecific e honoa ana ki tētahi kawenga aukati topo-I hou (Ed-04) mā tētahi hononga wehewehe e hangai ana ki te tetrapeptide pumau. Ka āraihia e te tikanga mahi takirua a Iza-bren ngā tohu EGFR me HER3 ki ngā pūtau matepukupuku, ka whakaitihia ngā tohu tipu me te oranga. Hei tāpiri, i te whakaurunga o te paturopi ki roto, ka tukuna te kawenga rongoā a Iza-bren ka puta he ahotea paitini ira tangata ka arahi ki te mate o ngā pūtau matepukupuku.
I te Hui-ā-Tau a te American Society of Clinical Oncology (ASCO) 2025, i whakaaturia ngā hua o te BL-B01D1 i roto i ngā tūroro he mate pukupuku pūkahukahu kore-pūtau iti (NSCLC) kua horapa ki te rohe, kua horapa rānei, e mau ana i ngā whakarerekētanga ira taketake (GA) i tua atu i ngā whakarerekētanga EGFR matarohia.
Ngā Tikanga: Ko te wāhanga Wāhanga Ib o tēnei rangahau i whakaurua ngā rōpū whānui, ia rōpū i tautuhia e tētahi GA kua tohua i mua, tae atu ki ngā whakaurunga EGFR exon 20, ngā whakarerekētanga EGFR kore-tūturu, ngā whakarerekētanga i roto i te HER2, ALK, ROS1, BRAF (V600E me ētahi atu), KRAS (G12C me ētahi atu), SMARCA4, MET (Exon 14), RET, me te NTRK. Ko ngā tāngata whai GA nei i ahu whakamua i runga i ngā maimoatanga whainga paerewa (mēnā e wātea ana) me te kore e neke atu i te kotahi te rārangi chemotherapy o mua i whakaurua. I hoatu te iza-bren i te 2.5 mg/kg D1D8 Q3W.
Ngā Hua: I te 5 o Tīhema, 2024, e 73 ngā tohu NSCLC me te GA kua whakarārangihia i whakaurua. E rima ngā tohu i rongoatia tonu, engari i tangohia mai i te tātaritanga nā te korenga o te aroturukitanga mō te matawai tuatahi i muri i te tīmatanga (tirohia te ripanga i raro nei). I roto i ngā tohu e 7 me ngā whakaurunga EGFR exon 20, 85.7% (6 i roto i te 7) i eke ki te cPR. I roto i ngā tohu e 8 me ngā whakarerekētanga KRAS G12C, e 3 cPR me te 1 PR e tatari ana kia whakaūtia i kitea. Ka whakaaturia te whai huatanga mō ngā rōpū iti. Ko ngā TRAE toto tino kitea (ngā taumata katoa) ko te anemia (87.7%), te leukopenia (74.0%), te thrombocytopenia (74.0%), me te neutropenia (72.6%); Ko ngā TRAE kāore i te mate toto i tino kitea ko te asthenia (42.5%), te whakapairuaki (41.1%), te stomatitis (37.0%), te korere (32.9%), me te alopecia (31.5%). Ko ngā TRAE taumata 3 me runga ake nei, he mate toto te nuinga, i taea te whakahaere pai mā te whakamahi i ngā tikanga tautoko paerewa tae atu ki te whakaiti i te horopeta, e whakaatuhia ana e te TRAE, ā, i hua ake ai te tere whakamutu o te 2.7%. Kotahi anake te take o te G2 ILD i kitea. He mea nui, kāore he mate e pā ana ki te iza-bren i pūrongohia. Kāore he tohu haumaru hou i kitea.
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.
Tau Waea：4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Wā tuku: Hepetema-05-2025