Na Machị 13, 2025, akwụkwọ akụkọ mba ụwa kachasị elu bụ́ Nature Medicine bipụtara nnwale MediLink nke B7-H3 nke na-elekwasị anya na ọgwụ mgbochi ọrịa (ADC) YL201 Phase 1/1b.
Nnwale ahụ gụnyere akụkụ mbelata dose (nkebi nke 1) na akụkụ mmụba dose (nkebi nke 1b). E debanyere ndị ọrịa 312 n'ọtụtụ ụdị etuto ahụ, gụnyere kansa akpa ume obere sel dị elu (ES-SCLC), kansa akpa ume nasopharyngeal (NPC), kansa akpa ume nke na-abụghị obere sel, kansa akpa ume nke esophageal squamous cell na etuto ndị ọzọ siri ike.
N'ime ndị ọrịa 287 a tụlere maka irè ha, ọnụego nzaghachi ebumnuche (ORR) bụ 40.8%, ebe ọnụego njikwa ọrịa (DCR) bụ 83.6%. Ọnụọgụ ndụ nke na-enweghị ọganihu (mPFS) bụ ọnwa 5.9, oge nzaghachi (mDOR) bụ ọnwa 6.3. Ọnụọgụ ndụ nke etiti (OS) etozubeghị oke.
N'ime ndị ọrịa 48 nwere nsogbu ụbụrụ dị n'okpuru ala, a tụlere mmadụ 21; ORR dị n'ime ụbụrụ bụ 28.5%; DOR dịkwa ọnwa 6.2.
Ndị ọrịa niile nwere ES-SCLC natara ọgwụgwọ mbụ site na iji ọgwụ chemotherapy dabere na platinum, 95.8% nke ndị ọrịa nwetakwara ọgwụgwọ mbụ site na ọgwụ mgbochi ọnwụ 1 (PD-1) ma ọ bụ ọgwụ mgbochi ọnwụ ligand 1 (PD-L1) nke enyere. ORR bụ 63.9%; DCR bụ 91.7%; mPFS bụ ọnwa 6.3; mDOR bụkwa ọnwa 5.7. N'ọmụmụ ihe gbasara mmụba dose, e debanyere aha ndị ọrịa ise nwere SCLC bụ ndị natara ọgwụgwọ mbụ site na iji topoisomerase 1 inhibitor (topotecan ma ọ bụ irinotecan), naanị otu onye ọrịa zara (ORR, 20%). N'ime ndị ọrịa 70 nwere NPC, ha niile natara ọgwụgwọ mbụ site na ọgwụ chemotherapy dabere na PD-L1 na platinum, 84.3% (59/70) nwekwara usoro ọgwụgwọ sistemụ abụọ ma ọ bụ karịa. Mmadụ abụọ n'ime ndị nwere NPC nwetara nzaghachi zuru oke (CR), yana ORR nke 48.6% na DCR nke 92.9%. MKPFS dị ọnwa 7.8, mDOR dịkwa ọnwa 8.4. A nwalere ngụkọta nke ndị ọrịa 64 nwere ụdị NSCLC ọhịa, gụnyere mmadụ 28 nwere adenocarcinoma, mmadụ 12 nwere squamous cell carcinoma na mmadụ 24 nwere lymphoepithelioma-like carcinoma (LELC). Na mkpokọta, 90.6% (58/64) nke ndị ọrịa nwere NSCLC natara ọgwụgwọ mbụ site na iji ọgwụ anti-PD-L1 na platinum-based chemotherapy. Ọnụọgụ ORR maka ndị ọrịa nwere adenocarcinoma akpa ume, squamous cell carcinoma na LELC bụ 28.6%, 8.3% na 54.2%, n'otu n'otu, mDOR bụkwa ọnwa 13.6, ọnwa 2.6 na ọnwa 6.7, n'otu n'otu.
YL201 gosipụtara profaịlụ nchekwa a na-anabata yana irè dị mma n'ahụ ndị ọrịa a na-agwọbeghị nke ukwuu nwere etuto siri ike dị elu, ọkachasị ndị nwere kansa ES-SCLC, NPC ma ọ bụ lymphoepithelioma-dị ka lymphoepithelioma.
YL201 bụ ADC ọhụrụ nke nwere ọgwụ mgbochi B7H3 monoclonal nke mmadụ jikọtara na ihe mgbochi topoisomerase 1 ọhụrụ site na njikọ protease-cleavable, yana oke ọgwụ-na-antibody nke 8. E ji ikpo okwu MediLink nke tumor microenvironment activable linker-payload (TMALIN) mepụta YL201, nke a na-eji nnukwu hydrophilic linker-payload mara, nkwụsi ike dị egwu na mgbasa ozi na usoro mwepụta ụgwọ abụọ nke gụnyere cleavage ma na extracellular na tumor microenvironment na intracellularly n'ime lysosomes. N'ọmụmụ ihe tupu ọgwụgwọ, YL201 gosipụtara ọrụ mgbochi tumor dị ike na ụdị òké CDX/PDX dị iche iche nwere SCLC, NSCLC, kansa esophageal na kansa ovarian. Data arụmọrụ na nchekwa sitere na ọmụmụ ihe tupu ọgwụgwọ a na-atụ aro uru dị mma-ihe egwu, na-akwado mmepe ọzọ nke YL201 na ụlọ ọgwụ ahụ.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
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Oge ozi: Eprel-08-2025