Ngo-Agasti 13, 2025, i-Pacific Time, iwebhusayithi esemthethweni yeNgqungquthela Yomhlaba Yomdlavuza Wamaphaphu ka-2025 (WCLC) ikhiphe izifinyezo zocwaningo ezikhethiwe zengqungquthela yalo nyaka, Phakathi kwezinto ezivelele kukhona isifinyezo esibuyekeziwe sesilingo sokuqala somtholampilo seSigaba 1 se-HLX43, i-Henlius' PD-L1 ADC.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
I-HLX43 iyi-ADC yokulwa nomdlavuza ebanzi ehlose i-PD-L1, ebonisa izindlela ezimbili ezihlanganisa ukuvimba kokuhlolwa kwamasosha omzimba kanye nobuthi obubangelwa yi-payload. Imininingwane yangaphambi kokwelashwa ikhombisile ukuthi, i-HLX43 inemiphumela emihle yokulwa nomdlavuza kanye nephrofayili yokubekezelela okuhle kumdlavuza wamaphaphu ongewona amaseli amancane (i-NSCLC), umdlavuza wesibeletho (i-CC), i-esophageal squamous cell carcinoma (i-ESCC), kanye nezinye izinhlobo zomdlavuza ezazingamelani ne-PD-1/L1 mAb.
Ngokusho kwesifinyezo esibuyekeziwe, i-HLX43 iyaqhubeka nokukhombisa izinga eliphezulu lokuphendula ezigulini ezinezimila eziqinile ezithuthukile, ikakhulukazi ezigulini ze-NSCLC ezelashwe ngaphambilini ezihlulekile ukwelashwa kwe-checkpoint inhibitor. I-HLX43 ikhombisa ukusebenza kahle okuphezulu emaqenjini athile amancane, ngesilinganiso sokuphendula esiqondile (ORR) esingu-47.4% ku-EGFR wild-type non-squamous NSCLC, ngenkathi igcina iphrofayili yokuphepha enhle. Okuphawulekayo ukuthi i-HLX43 ikhombisa ukusebenza kahle okuqinile kungakhathaliseki ukubonakaliswa kwe-PD-L1, okubonisa amandla ayo okulwa nomdlavuza azimele ngokwe-biomarker.
Kusebenza kahle ekwelashweni kwe-NSCLC emelana ne-CPI: Kusukela ngomhlaka-28 kuNhlolanja 2025, iziguli ezingu-85 zizonke zathola i-HLX43. Esigabeni Ia (ukwanda komthamo), iziguli ezingu-21 ezinezimila eziqinile ezithuthukile zabhaliswa, kanti esigabeni Ib (ukwanda komthamo), iziguli ezingu-64 ze-NSCLC zaqashwa emaqenjini amathathu (2, 2.5, kanye no-3 mg/kg). Okuphawulekayo ukuthi, u-88.2% (75/85) weziguli wehlulekile ukwelashwa kwangaphambilini kwe-checkpoint inhibitor (CPI).
Ukusebenza Okuthembisayo ku-NSCLC Ngemiphumela Ephawulekayo Kumaqembu Athile Angaphansi: Phakathi kweziguli ezingu-76 ze-NSCLC (ezihlolwa ukusebenza kahle okungu-69), i-ORR yayingu-31.9% (22/69), ngesilinganiso sokulawula izifo (DCR) esingu-87.0% (60/69). Ukuhlaziywa kwamaqembu angaphansi kubonise ukusebenza kahle okuthembisayo kwe-HLX43 kubantu abathile: amaqembu angu-2 mg/kg kanye no-2.5 mg/kg ku-Phase Ib athole ama-ORR angu-38.1% (8/21) kanye no-33.3% (7/21), ngokulandelana; iziguli ze-NSCLC eziphikisana ne-CPI (n=61) zibonise i-ORR engu-32.8% (20/61); iziguli ze-NSCLC ezingezona ezi-squamous ze-EGFR (n=19) zazine-ORR engu-47.4% (9/19).
Iphrofayili Yokuphepha Enhle, Ukusebenza Okuphezulu Nobuthi Obuphansi: Esigabeni Ia, isigameko esisodwa se-DLT esihilela i-febrile neutropenia sabonwa eqenjini lama-4 mg/kg. Izehlakalo ezimbi ezihlobene nokwelashwa (ama-TRAE) zabikwa kuma-95.2% eziguli, ikakhulukazi iBanga 1-2. IBanga ≥3 Ama-TRAE enzeka ezigulini ezi-5 (23.8%), zonke zivela kuma-cohorts ama-3 nama-4 mg/kg, inani lama-neutrophil elinciphile kakhulu (19%), inani lamaseli amhlophe egazi elinciphile (19.0%) kanye ne-anemia (14.3%). Izehlakalo ezimbi ezihlobene nokuzivikela komzimba (ama-irAE) ezibikwe kulolu cwaningo ziphakamisa ukuthi i-HLX43 iyakwazi ukuveza imiphumela yokwelapha nge-immunotherapy. Okuphawulekayo ukuthi iziguli ezibike ama-irAE zibonise izinga eliphezulu lokuphendula eliqondile (ORR).
Isebenza kahle ezimweni ezahlukene ze-biomarker: Iziguli ze-NSCLC ezine-PD-L1 (n=50) zibonise i-ORR engu-32.0% (16/50) kuyilapho iziguli ezine-PD-L1/ezingaziwa (n=19) zithole i-ORR engu-31.6% (6/19), ngaphandle komehluko obalulekile obonwe.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Agasti-15-2025