Na Machị 31, 2025, Innovent Biologics kwupụtara na Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) enyela Breakthrough Therapy Nomination (BTD) maka IBI363, protein PD-1/IL-2α-bias nke mbụ na klas nke abụọ nke antibody fusion, dị ka monotherapy maka ọgwụgwọ nke mucosal mucosal ma ọ bụ acral melanoma nke na-enweghị ike iwepụ ma ọ bụ metastatic metastatic mucosal ma ọ bụ acral melanoma ndị na-enwetabeghị ọgwụgwọ sistemu mbụ.
Banyere IBI363 (Protein ngwakọta nke antibody bispecific PD-1/IL-2α-bias nke mbụ)
IBI363 bụ ọgwụ mbụ a na-ahọrọ n'ọkwa nke Innovent Biologics mepụtara n'onwe ya. Ọ bụ protein PD-1/IL-2 nke nwere ike itinye ihe mgbochi nje bispecific nke e mere iji mee ka arụmọrụ dịkwuo mma ma belata nsí. E mepụtara ogwe aka IL-2 nke IBI363 iji mee ka mmetụta ọgwụgwọ dịkwuo mma yana mbelata mmetụta ọjọọ, ebe ogwe aka njikọ PD-1 na-enye ohere igbochi PD-1 na nnyefe IL-2 nhọrọ. Site n'igbochi ụzọ PD-1/PD-L1 n'otu oge ma na-eme ka ụzọ IL-2 rụọ ọrụ, IBI363 na-eme ka ebumnuche na ọrụ nke mkpụrụ ndụ T kpọmkwem nke etuto ahụ dịkwuo mma ma dị irè. Ọmụmụ ihe tupu oge eruo egosila na IBI363 na-egosipụta ọrụ mgbochi etuto siri ike n'ọtụtụ ụdị ọgwụ ndị na-ebu etuto ahụ, gụnyere ndị na-eguzogide ihe mgbochi PD-1 na ụdị metastatic. Na mgbakwunye, o gosipụtala profaịlụ nchekwa dị mma na ụdị tupu oge eruo.
A na-eme nnwale ahụike nke IBI363 ugbu a na China, United States, na Australia iji nyochaa nchekwa ya, nnabata ya na irè mbụ ya na ndị nwere ọrịa kansa dị elu. A malitela ọmụmụ ihe mbụ dị mkpa nke IBI363, maka ọgwụgwọ nke IO-naive mucosal ma ọ bụ acral melanoma.
Ọzọkwa, IBI363 enwetala aha abụọ dị ngwa ngwa (FTD) site na US FDA, maka ọgwụgwọ melanoma na squamous NSCLC, n'otu n'otu. IBI363 enwetakwala aha ọgwụgwọ breakthrough site na NMPA nke China maka ọgwụgwọ melanoma.
Innovent na-egosi data ahụike nke usoro nke mbụ nke PD-1/IL-2α Bispecific Antibody Fusion Protein (IBI363) na Melanoma na Nzukọ Kwa Afọ nke 2024 ASCO.
E debanyere aha mmadụ 67 nwere melanoma dị elu n'ógbè ahụ ma ọ bụ nke melanomas metastatic nke dara ada ma ọ bụ na-anaghị anabata ọgwụgwọ a na-enye n'oge a na-agwọ ha, ma nata IBI363 n'ime akwara na ọkwa dose dị n'etiti 100 μg/kg QW na 2 mg/kg Q3W. 89.6% nke ndị nwere ọrịa ahụ natara ọgwụgwọ immunotherapy tupu oge eruo, 61.2% nke ndị nwere ọrịa ahụ nwekwara ≥ usoro ọgwụgwọ sistemu 2 tupu oge eruo. 25.4% nke ndị nwere ọrịa ahụ nwere metastasis imeju na 70.1% nke ndị nwere ọrịa ahụ bụ ụdị acral ma ọ bụ mucosal.
Dịka ọ dị na Jenụwarị 11, 2024, mmadụ 57 nwere opekata mpe otu nyocha etuto ahụ mgbe mmalite. Azịza kachasị mma bụ nzaghachi zuru oke (CR) na otu onye, nzaghachi akụkụ (PR) na mmadụ 15 n'otu n'otu. Ọnụego nzaghachi zuru oke (ORR) bụ 28.1% (95%CI: 17.0-41.5) na DCR bụ 71.9% (95%CI: 58.5-83.0). Na mmadụ 25 a gwọrọ ọrịa immunotherapy (IO) na otu dose Q2W 1mg/kg (n=25), ORR bụ 32.0% (95%CI: 14.9-53.5), DCR bụ 80.0% (95%CI: 59.3-93.2).
Maka nchekwa, mmadụ 16 (23.9%) nwere ihe mberede ọgwụgwọ nke ọkwa ≥3 (TEAEs). Ihe mberede ọgwụgwọ nke ọkwa ≥3 bụ ọrịa ogbu na nkwonkwo (34.3%), hyperthyroidism (29.9%), na anaemia (25.4%). Ihe mberede metụtara ahụ ike nke ọkwa ≥3 (IRAEs) mere na mmadụ 8 (11.9%). Enweghị TRAE butere ọnwụ.
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-01-2025