Pa Ogasiti 13, 2025, Pacific Time, tsamba lovomerezeka la Msonkhano Wapadziko Lonse wa 2025 pa Khansa ya M'mapapo (WCLC) linatulutsa chidule cha kafukufuku chomwe chasankhidwa pamsonkhano wa chaka chino, Pakati pa mfundo zazikulu ndi chidule chaposachedwa cha mayeso oyamba azachipatala a Gawo 1 a HLX43, Henlius' PD-L1 ADC.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Chizindikiro cha WeChat: 17801183037
Email：myimmnet@163.com
HLX43 ndi mankhwala a ADC olimbana ndi chotupa omwe amayang'ana kwambiri PD-L1, omwe ali ndi njira ziwiri zophatikizira chitetezo chamthupi komanso poizoni wobwera chifukwa cha payload. Deta yoyambirira yawonetsa kuti HLX43 ili ndi zotsatira zabwino zotsutsana ndi chotupa komanso mawonekedwe abwino olekerera khansa ya m'mapapo yopanda maselo ang'onoang'ono (NSCLC), khansa ya pachibelekero (CC), khansa ya esophageal squamous cell carcinoma (ESCC), ndi mitundu ina ya chotupa yomwe inali yosagonja ku PD-1/L1 mAb.
Malinga ndi chidule chomwe chasinthidwa, HLX43 ikupitilizabe kuwonetsa kuchuluka kwa mayankho mwa odwala omwe ali ndi zotupa zolimba kwambiri, makamaka kwa odwala a NSCLC omwe adachiritsidwa kale omwe adalephera chithandizo cha checkpoint inhibitor. HLX43 ikuwonetsa kugwira ntchito bwino kwambiri m'magulu enaake, ndi chiwongola dzanja choyankha (ORR) cha 47.4% mu EGFR wild-type non-squamous NSCLC, pomwe ikusunga mbiri yabwino yotetezeka. Chodziwika bwino ndichakuti, HLX43 ikuwonetsa kugwira ntchito bwino mosasamala kanthu za PD-L1, kusonyeza kuthekera kwake kotsutsana ndi chotupa komwe sikudalira biomarker.
Kugwira Ntchito Pakuchiza Pambuyo Pake kwa NSCLC Yosagonjetsedwa ndi CPI: Kuyambira pa 28 February, 2025, odwala 85 onse adalandira HLX43. Mu Phase Ia (kuwonjezeka kwa mlingo), odwala 21 omwe ali ndi zotupa zolimba adalembedwa, pomwe mu Phase Ib (kukulitsa mlingo), odwala 64 a NSCLC adalembedwa m'magulu atatu (2, 2.5, ndi 3 mg/kg). Chodziwika bwino n'chakuti, 88.2% (75/85) ya odwala adalephera kulandira chithandizo cha pre-checkpoint inhibitor (CPI) asanalandire.
Kugwira Ntchito Kodalirika mu NSCLC Ndi Zotsatira Zodziwika M'magulu Ang'onoang'ono Omwe Ali Ndi Matenda: Pakati pa odwala 76 a NSCLC (omwe amayesedwa kuti ndi othandiza), ORR inali 31.9% (22/69), ndi chiwongola dzanja chowongolera matenda (DCR) cha 87.0% (60/69). Kusanthula kwa magulu ang'onoang'ono kunawonetsa kugwira ntchito kodalirika kwa HLX43 mwa anthu enaake: magulu a 2 mg/kg ndi 2.5 mg/kg mu Phase Ib adapeza ma ORR a 38.1% (8/21) ndi 33.3% (7/21), motsatana; odwala a NSCLC osagwira ntchito (n=61) adawonetsa ORR ya 32.8% (20/61); odwala a EGFR omwe si a squamous NSCLC (n=19) anali ndi ORR ya 47.4% (9/19).
Mbiri Yabwino Yachitetezo, Kugwira Ntchito Kwambiri Ndi Kuopsa Kochepa: Mu Gawo Ia, chochitika chimodzi cha DLT chokhudzana ndi neutropenia ya febrile chinawonedwa m'gulu la 4 mg/kg. Zochitika zoyipa zokhudzana ndi chithandizo (TRAEs) zidanenedwa mwa 95.2% ya odwala, makamaka Giredi 1-2. Giredi ≥3 TRAEs zidachitika mwa odwala 5 (23.8%), onse ochokera m'magulu a 3 ndi 4 mg/kg, nthawi zambiri kuchepa kwa chiwerengero cha neutrophil (19%), kuchepa kwa chiwerengero cha maselo oyera amagazi (19.0%) ndi kuchepa kwa magazi m'thupi (14.3%). Zochitika zoyipa zokhudzana ndi chitetezo chamthupi (irAEs) zomwe zidanenedwa mu kafukufukuyu zikusonyeza kuti HLX43 imatha kuyambitsa zotsatira za immunotherapy. Chodziwika bwino ndichakuti, odwala omwe adanena kuti irAEs adawonetsa kuchuluka kwa yankho lolunjika (ORR).
Ogwira ntchito bwino m'magawo osiyanasiyana a biomarker: Odwala a NSCLC omwe ali ndi PD-L1 (n=50) adawonetsa ORR ya 32.0% (16/50) pomwe odwala omwe alibe PD-L1/osadziwika (n=19) adapeza ORR ya 31.6% (6/19), popanda kusiyana kwakukulu komwe kwawonedwa.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Chizindikiro cha WeChat: 17801183037
Email：myimmnet@163.com
Nthawi yotumizira: Ogasiti-15-2025