A ranar 13 ga Agusta, 2025, Pacific Time, gidan yanar gizon hukuma na Taron Duniya kan Ciwon Huhu na 2025 (WCLC) ya fitar da taƙaitaccen bayani game da binciken da aka zaɓa don taron na wannan shekara, Daga cikin abubuwan da suka fi jan hankali akwai sabon taƙaitaccen bayani game da gwajin asibiti na farko a cikin ɗan adam na HLX43, Henlius' PD-L1 ADC.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
Lambar Waya: 4008803716
Shaidar WeChat: 17801183037
Email：myimmnet@163.com
HLX43 wani nau'in ADC ne mai faffadan tsari na hana ciwace-ciwacen da ke nufin PD-L1, wanda ke nuna hanyoyi biyu da suka haɗa da toshewar wuraren binciken garkuwar jiki da kuma gubar da ke haifar da yawan aiki. Bayanan da aka riga aka samu a asibiti sun nuna cewa, HLX43 yana da kyawawan tasirin hana ciwace-ciwacen da kuma kyakkyawan yanayin jurewa a cikin ciwon daji na huhu na ƙananan ƙwayoyin halitta (NSCLC), ciwon daji na mahaifa (CC), ciwon daji na ƙwayar cuta ta esophageal squamous cell (ESCC), da sauran nau'ikan ciwace-ciwacen da ke jure wa PD-1/L1 mAb.
A cewar sabon taƙaitaccen bayani, HLX43 yana ci gaba da nuna babban matakin amsawa ga marasa lafiya da ke da ciwon daji mai ƙarfi, musamman a cikin marasa lafiya da aka riga aka yi wa magani kafin su kasa maganin hana wuraren bincike. HLX43 yana nuna ingantaccen tasiri a cikin takamaiman ƙananan ƙungiyoyi, tare da ƙimar amsawa ta zahiri (ORR) na 47.4% a cikin NSCLC mara squamous na EGFR, yayin da yake kiyaye kyakkyawan bayanin aminci. Abin lura shi ne, HLX43 yana nuna ingantaccen tasiri ba tare da la'akari da bayyanar PD-L1 ba, yana nuna yuwuwar maganin ƙari mai zaman kansa ta hanyar biomarker.
Yana da Inganci a Maganin NSCLC Mai Juriya ga CPI Daga Baya: Ya zuwa ranar 28 ga Fabrairu, 2025, jimillar marasa lafiya 85 sun karɓi HLX43. A Mataki na Ia (ƙara yawan allurai), an yi wa marasa lafiya 21 da ke da ciwon daji mai tsanani rajista, yayin da a Mataki na Ib (ƙara yawan allurai), an ɗauki marasa lafiya 64 na NSCLC a cikin ƙungiyoyi uku (2, 2.5, da 3 mg/kg). Abin lura shi ne, kashi 88.2% (75/85) na marasa lafiya sun gaza a maganin hana duba wuraren bincike (CPI) da aka yi a baya.
Inganci Mai Kyau a NSCLC Tare da Sakamako Masu Kyau a Takamaiman Ƙungiyoyi: Daga cikin marasa lafiya 76 na NSCLC (wanda za a iya kimanta inganci 69), ORR ya kasance 31.9% (22/69), tare da ƙimar sarrafa cututtuka (DCR) na 87.0% (60/69). Binciken ƙananan ƙungiyoyi ya nuna ingantaccen tasiri na HLX43 a cikin takamaiman al'ummomi: ƙungiyoyi 2 mg/kg da 2.5 mg/kg a cikin Phase Ib sun cimma ORRs na 38.1% (8/21) da 33.3% (7/21), bi da bi; marasa lafiya na NSCLC masu hana CPI (n=61) sun nuna ORR na 32.8% (20/61); marasa lafiya na NSCLC marasa kamuwa da cuta na EGFR (n=19) suna da ORR na 47.4% (9/19).
Bayanin Tsaro Mai Kyau, Ingantaccen Inganci Tare da Ƙananan Guba: A Mataki na Ia, an lura da wani lamari na DLT wanda ya shafi zazzabin cizon sauro a cikin rukunin 4 mg/kg. An ruwaito abubuwan da suka shafi magani (TRAEs) a cikin 95.2% na marasa lafiya, galibi Aji na 1-2. TRAEs na aji ≥3 sun faru a cikin marasa lafiya 5 (23.8%), duk daga ƙungiyoyi 3 da 4 mg/kg, galibi sun ragu da adadin neutrophil (19%), raguwar adadin fararen ƙwayoyin jinin jini (19.0%) da anemia (14.3%). Abubuwan da suka shafi garkuwar jiki (irAEs) da aka ruwaito a cikin wannan binciken sun nuna cewa HLX43 yana da ikon haifar da tasirin immunotherapy. Abin lura shi ne, marasa lafiya da suka ba da rahoton irAEs sun nuna ƙimar amsawar da ta fi girma (ORR).
Yana aiki a yanayin alamun halitta daban-daban: Marasa lafiya da ke da PD-L1-positive NSCLC (n=50) sun nuna ORR na 32.0% (16/50) yayin da marasa lafiya da ba a san su ba na PD-L1-negative/ba a san su ba (n=19) suka sami ORR na 31.6% (6/19), ba tare da an lura da wani bambanci mai mahimmanci ba.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
Lambar Waya: 4008803716
Shaidar WeChat: 17801183037
Email：myimmnet@163.com
Lokacin Saƙo: Agusta-15-2025