Ngomhla we-13 kweyeThupha, ngowama-2025, iPacific Time, iwebhusayithi esemthethweni yeNgqungquthela yeHlabathi yoMhlaza weMiphunga ka-2025 (WCLC) ikhuphe izishwankathelo zophando ezikhethiweyo zengqungquthela yalo nyaka, Phakathi kwezinto eziphambili sisishwankathelo esihlaziyiweyo sovavanyo lokuqala lweklinikhi lweSigaba soku-1 ebantwini lwe-HLX43, i-PD-L1 ADC kaHenlius.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
I-HLX43 yi-ADC elwa ne-tumor ejolise kwi-PD-L1, ebonisa iindlela ezimbini ezidibanisa i-immune checkpoint blockade kunye ne-payload-mediated cytotoxicity. Idatha yangaphambi kweklinikhi ibonise ukuba, i-HLX43 inemiphumo emihle yokulwa ne-tumor kunye neprofayili efanelekileyo yokunyamezeleka kumhlaza wemiphunga ongengowe-small cell lung cancer (NSCLC), umhlaza wesibeleko (CC), i-esophageal squamous cell carcinoma (ESCC), kunye nezinye iintlobo ze-tumor ezazingamelani ne-PD-1/L1 mAb.
Ngokwesishwankathelo esihlaziyiweyo, i-HLX43 iyaqhubeka nokubonisa izinga eliphezulu lokuphendula kwizigulane ezineethumba eziqinileyo eziphucukileyo, ngakumbi kwizigulane ze-NSCLC ezinyangiweyo kwangaphambili ezingaphumelelanga kunyango lwe-checkpoint inhibitor. I-HLX43 ibonisa ukusebenza okuphezulu kumaqela athile amancinci, kunye nezinga lokuphendula elijolise ngqo (ORR) le-47.4% kwi-EGFR wild-type non-squamous NSCLC, ngelixa igcina iprofayili yokhuseleko efanelekileyo. Okuphawulekayo kukuba, i-HLX43 ibonisa ukusebenza okuqinileyo nokuba i-PD-L1 ibonakalisa njani, nto leyo ebonisa amandla ayo okulwa nethumba azimeleyo kwi-biomarker.
Isebenza kakuhle kuNyango lweLater-Line lwe-NSCLC enganyangekiyo yi-CPI: Ukusukela nge-28 kaFebruwari 2025, izigulane ezingama-85 zizonke zafumana i-HLX43. KwiSigaba Ia (ukunyuka kwedosi), izigulane ezingama-21 ezineethumba eziqinileyo eziqhubele phambili zabhaliswa, ngelixa kwiSigaba Ib (ukwandiswa kwedosi), izigulane ezingama-64 ze-NSCLC zaqeshwa kwiiqela ezintathu (2, 2.5, kunye ne-3 mg/kg). Okuphawulekayo kukuba, i-88.2% (75/85) yezigulane ayizange iphumelele unyango lwangaphambili lwe-checkpoint inhibitor (CPI).
Ukusebenza Okuthembisayo kwi-NSCLC kunye neziphumo eziphawulekayo kwiiNqanaba ezithile: Phakathi kwezigulane ezingama-76 ze-NSCLC (ezivavanywayo ngokusebenza ngempumelelo ezingama-69), i-ORR yayiyi-31.9% (22/69), kunye nezinga lokulawula isifo (DCR) eliyi-87.0% (60/69). Uhlalutyo lweqela elincinci lubonise ukusebenza okuthembisayo kwe-HLX43 kumaqela athile: amaqela angama-2 mg/kg kunye nama-2.5 mg/kg kwiSigaba Ib afumene ii-ORR ezingama-38.1% (8/21) kunye nama-33.3% (7/21), ngokulandelelana; izigulane ze-NSCLC ezichasene ne-CPI (n=61) zibonise i-ORR engama-32.8% (20/61); izigulane ze-EGFR ze-wild-type non-squamous NSCLC (n=19) zine-ORR engama-47.4% (9/19).
Iprofayili yoKhuseleko oluLungileyo, Ukusebenza okuphezulu kunye nobuthi obuphantsi: KwiSigaba Ia, isiganeko esinye se-DLT esibandakanya i-febrile neutropenia sabonwa kwiqela le-4 mg/kg. Iziganeko ezimbi ezinxulumene nonyango (ii-TRAE) zibikwe kwi-95.2% yezigulane, uninzi lwazo ziBanga loku-1-2. Ii-TRAE zeBanga loku-≥3 zenzeke kwizigulane ezi-5 (23.8%), zonke zivela kwii-cohorts ezi-3 nezi-4 mg/kg, uninzi lwazo lunciphile kakhulu inani le-neutrophil (19%), ukwehla kwenani leeseli ezimhlophe zegazi (19.0%) kunye ne-anemia (14.3%). Iziganeko ezimbi ezinxulumene nomzimba (ii-irAE) ezibikwe kolu phononongo zibonisa ukuba i-HLX43 inako ukuvelisa iziphumo zonyango. Okuphawulekayo kukuba, izigulane ezibike ii-irAE zibonise izinga eliphezulu lokuphendula elijolise ngqo (i-ORR).
Isebenza kakuhle kwiimeko ezahlukeneyo ze-biomarker: Izigulane ze-NSCLC ezine-PD-L1-positive (n=50) zibonise i-ORR engama-32.0% (16/50) ngelixa izigulane ezine-PD-L1-negative/ezingaziwayo (n=19) zifumene i-ORR engama-31.6% (6/19), kungekho mahluko ubalulekileyo uboniweyo.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Ixesha leposi: Agasti-15-2025