A ranar 13 ga Maris, 2025, babbar mujallar kasa da kasa ta Nature Medicine ta buga gwajin maganin rigakafi na B7-H3 na MediLink wanda ke nufin maganin rigakafi na YL201 Phase 1/1b.
Gwajin ya haɗa da ɓangaren ƙaruwar allurai (mataki na 1) da ɓangaren faɗaɗa allurai (mataki na 1b). An yi wa jimillar marasa lafiya 312 rajista a cikin nau'ikan ƙari daban-daban, ciki har da ciwon daji na ƙananan ƙwayoyin cuta (ES-SCLC), ciwon daji na nasopharyngeal (NPC), ciwon daji na huhu wanda ba ƙaramin ƙwayoyin cuta ba ne, ciwon daji na ƙwayoyin cuta na esophageal da sauran ciwon daji masu ƙarfi.
Daga cikin marasa lafiya 287 da aka kimanta don inganci, ƙimar amsawar da aka yi niyya (ORR) shine 40.8%, kuma ƙimar kula da cutar (DCR) shine 83.6%. Matsakaicin rayuwa ba tare da ci gaba ba (mPFS) shine watanni 5.9, kuma matsakaicin tsawon lokacin amsawa (mDOR) shine watanni 6.3. Matsakaicin rayuwa gabaɗaya (OS) bai girma ba.
Daga cikin marasa lafiya 48 da suka kamu da cutar sankarar kwakwalwa, an kimanta su 21; ORR na cikin kwakwalwa shine 28.5%; kuma DOR shine watanni 6.2.
Duk marasa lafiya da ke fama da cutar ES-SCLC sun yi musu magani a baya da maganin chemotherapy na tushen platinum, kuma kashi 95.8% na marasa lafiya sun kuma yi musu magani a baya da maganin death 1 (PD-1) ko kuma maganin death ligand 1 (PD-L1) na rigakafi. ORR ya kasance kashi 63.9%; DCR ya kasance kashi 91.7%; mPFS ya kasance watanni 6.3; kuma mDOR ya kasance watanni 5.7. A cikin binciken da aka yi kan yawan shan magani, an yi wa marasa lafiya biyar da ke fama da cutar SCLC magani a baya da maganin topoisomerase 1 inhibitor (topotecan ko irinotecan), inda mutum ɗaya kawai ya amsa (ORR, 20%). Daga cikin marasa lafiya 70 da ke fama da cutar NPC, duk sun yi musu magani a baya da maganin chemotherapy na anti-PD-L1 da na platinum, kuma kashi 84.3% (59/70) sun sami layuka biyu ko fiye na magungunan da aka yi musu a baya. Biyu daga cikin marasa lafiya da ke fama da cutar NPC sun sami cikakken amsa (CR), tare da ORR na 48.6% da DCR na 92.9%. An yi gwajin mPFS na tsawon watanni 7.8, kuma mDOR ya yi watanni 8.4. An tantance jimillar marasa lafiya 64 da ke dauke da cutar NSCLC ta daji, ciki har da 28 da ke dauke da cutar adenocarcinoma, 12 da ke dauke da cutar squamous cell carcinoma da kuma 24 da ke dauke da cutar lymphoepithelioma-like carcinoma (LELC). Jimilla, kashi 90.6% (58/64) na marasa lafiya da ke dauke da cutar NSCLC sun yi jinya a baya ta hanyar amfani da maganin hana PD-L1 da kuma maganin platinum. Darajar ORR ga marasa lafiya da ke dauke da cutar adenocarcinoma ta huhu, cutar squamous cell carcinoma da LELC sun kai kashi 28.6%, 8.3% da 54.2%, bi da bi, kuma mDOR ya kai watanni 13.6, watanni 2.6 da watanni 6.7, bi da bi.
YL201 ya nuna ingantaccen bayanin aminci da kuma ingantaccen tasiri ga marasa lafiya da aka riga aka yi musu magani da yawa waɗanda ke da ciwon daji mai tsanani, musamman a cikin waɗanda ke da cutar kansa ta ES-SCLC, NPC ko lymphoepithelioma.
YL201 wani sabon ADC ne wanda ya ƙunshi wani maganin rigakafi na ɗan adam wanda aka haɗa shi da sabon maganin hana topoisomerase 1 ta hanyar haɗin da za a iya cirewa daga protease, tare da rabon magani-zuwa-antibody na 8. An haɓaka YL201 ta amfani da dandamalin haɗin gwiwa-payload na MediLink na tumor microenvironment activated linker-payload (TMALIN), wanda ke da alaƙa da nauyin haɗin gwiwa mai yawa, kwanciyar hankali mai ban mamaki a cikin zagayawa da kuma hanyar sakin nauyin nauyi biyu wanda ya haɗa da yankewa a cikin ƙwayoyin cuta a cikin ƙwayoyin cuta da kuma cikin ƙwayoyin cuta a cikin ƙwayoyin cuta. A cikin wani bincike na asibiti, YL201 ya nuna ƙarfin aikin hana ƙari a cikin nau'ikan linzamin kwamfuta daban-daban na CDX/PDX tare da SCLC, NSCLC, ciwon makogwaro da ciwon daji na ovarian. Bayanan inganci da aminci daga wannan binciken na asibiti sun nuna daidaito mai kyau na fa'ida-haɗari, yana tallafawa ci gaba da haɓaka YL201 a cikin asibitin.
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
Email：myimmnet@163.com
Lokacin Saƙo: Afrilu-08-2025