An haɗa IBI343 (CLDN 18.2 ADC) a matsayin maganin warkarwa mai nasara ta Hukumar Kayayyakin Lafiya ta Ƙasa don magance marasa lafiya da suka kamu da cutar ciwon daji ta pancreas.

A ranar 8 ga Janairu, Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta ba da izinin nadin Breakthrough Therapy (BTD) ga IBI343, wani magani mai inganci wanda zai iya zama mafi inganci a cikin TOPO1i anti-CLDN18.2 ADC, a matsayin maganin da ke magance marasa lafiya da ke fama da cutar CLDN18.2-positive wadanda suka ci gaba bayan akalla layi daya na magani mai tsari.

An bayar da BTD don IBI343 bisa ga bayanai daga wani bincike na Mataki na 1 da aka gudanar a China, Ostiraliya da Amurka (NCT05458219), wanda ya nuna aminci da juriya mai kyau, da kuma kyakkyawan aikin maganin ƙari na IBI343 a cikin marasa lafiya masu ci gaba da PDAC. An gabatar da bayanai daga ƙungiyar faɗaɗa allurai na binciken da baki a taron ESMO Asia na 2024:

Ya zuwa ranar 6 ga Satumba, 2024, jimillar marasa lafiya 43 da ke dauke da CLDN18.2-positive (≥60% ƙwayoyin ƙari tare da ƙarfin tabo na membrane ≥1+ ta IHC) sun sami IBI343 6 mg/kg Q3W guda ɗaya. Duk mahalarta sun taɓa samun aƙalla layi 1 na maganin da aka yi a baya, kuma 60.5% sun sami layi 2 ko fiye na maganin hana ciwon daji.

An kimanta ingancin marasa lafiya 43 tare da jimlar ƙimar amsawar manufa (ORR) na 32.6%, an tabbatar da ƙimar amsawar manufa (cORR) na 23.3%, da kuma ƙimar sarrafa cututtuka (cDCR) na 81.4%.

Yayin da ranar yanke bayanai ta ƙarshe, marasa lafiya 4 cikin 10 na cORR sun ci gaba, matsakaicin tsawon lokacin amsawar (mDoR) shine watanni 7.0 (4.0-NC), kuma ƙimar DoR na watanni 6 shine 63%. Marasa lafiya 26 sun fuskanci abubuwan da suka faru na PFS, tare da matsakaicin rayuwa ba tare da ci gaba ba (mPFS) na watanni 5.3 (4.1-7.4), kuma bayanan OS ba su cika ba tukuna.

Sakamakon tsaro da aka sabunta ya nuna kyakkyawan yanayin aminci na IBI343 tare da ƙarancin guba na ciki da kuma rashin sabbin siginar aminci. Kashi 97.7% na mahalarta sun fuskanci abubuwan da suka faru na rashin lafiya (TEAEs), inda mafi yawan TEAEs sune anemia, raguwar adadin neutrophils, raguwar ci, tashin zuciya, da raguwar adadin farin ƙwayoyin jini. Kashi 51.2% na mahalarta sun sami ≥ aji 3 TEAEs, kuma babu tashin zuciya da amai ≥ aji 3 da ya faru. Babu TEAE da ya kai ga mutuwa.

Game da IBI343(Anti-CLDN18.2 ADC)

IBI343 wani maganin rigakafi ne na ɗan adam mai hana CLDN18.2 monoclonal antibody-drug conjugate (ADC) wanda Innovent Biologics ya haɓaka. IBI343 yana ɗaurewa da ƙwayoyin ciwon daji masu bayyana CLDN18.2, za a sami shiga cikin CLDN18.2 wanda ke dogara da ADC kuma za a saki maganin wanda ke haifar da lalacewar DNA kuma daga ƙarshe apoptosis na ƙwayoyin ciwon. Maganin da aka saki kuma zai iya yaɗuwa a cikin membrane na plasma don isa da kashe ƙwayoyin da ke maƙwabta, wanda ke haifar da "tasirin kisa ta hanyar da ba ta dace ba".

A matsayin wani sabon tsari na TOPO1i ADC, IBI343 ya nuna aminci mai jurewa da kuma alamun inganta inganci a cikin nazarin asibiti na Mataki na 1. A halin yanzu ana binciken yuwuwar warkewa na IBI343 a cikin nau'ikan ciwon daji kamar ciwon ciki da na pancreas.

A watan Mayu na shekarar 2024, Hukumar Kula da Kayayyakin Lafiya ta Kasa ta kasar Sin (NMPA) ta ba da takardar maganin breakthrough therapy (BTD) ga IBI343 don amfani da shi a matsayin magani guda daya ga marasa lafiya da ke dauke da cutar CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma wadanda suka fuskanci ci gaban cutar bayan layuka biyu na maganin da aka yi musu a baya. Ana ci gaba da gudanar da gwajin mataki na 3 (NCT06238843) na IBI343 don wannan alamar.

A watan Yunin 2024, Hukumar Abinci da Magunguna ta Amurka (FDA) ta ba da IBI343 a matsayin magani mai sauri wanda ba a iya cirewa ko kuma wanda ya kamu da cutar kansar pancreas (PDAC) wanda ya sake dawowa da/ko kuma ya ƙi bin wani magani na baya. Ana ci gaba da gudanar da gwajin IBI343 na Mataki na 1 na yankuna da yawa (NCT05458219) na PDAC da aka yi wa magani a baya.

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.

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Email：myimmnet@163.com

Nassoshi

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.https://cn.innoventbio.com/#/

3.132MO Anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 a cikin marasa lafiya (pts) tare da ci gaba da ciwon daji na pancreas ductal adenocarcinoma (PDAC): Sakamakon da aka sabunta daga wani bincike na mataki na I - Annals of Oncology