Innovent Yawana Chitupa Chechipiri Chekukurumidza kubva kuUS FDA cheIBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) muSquamous Non-Small Cell Lung Cancer

Musi wa17 Kukadzi, 2025, Innovent Biologics yakazivisa kuti protein yayo yekutanga yePD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, yakagamuchira Fast Track Designation yayo yechipiri (FTD) kubva kuUS Food and Drug Administration (FDA). Zita iri rinoshanda pakurapa kenza yemapapu isina kubatwa, yakakwira munharaunda, kana metastatic squamous non-small cell lung cancer (sqNSCLC) yakaramba ichienderera mberi mushure mekurapa kwePD-(L)1 immune checkpoint inhibitor therapy uye platinum-based chemotherapy. IBI363 yakaratidza kushanda zvakanaka uye kuchengetedzeka mumhando dzakasiyana dzematumbu akasimba. Parizvino, Innovent iri kuita bvunzo dzekiriniki dzePhase 1/2 dzeBI363 kunyanya muChina nemuUS.

Kusarudzwa Kwekukurumidza (FTD) inzira yekutonga yakagadzirirwa kukurumidzisa kugadzirwa kwekiriniki nekuongorora mishonga yakagadzirirwa kurapa zvirwere zvakakomba uye kugadzirisa zvinodiwa zvehutano zvisina kuzadzikiswa. Vanhu vanoda mishonga vanopiwa FTD mukana wekuwedzera kutaurirana neFDA mukati mekugadzirwa kwemishonga kunotevera, zvichigona kukurumidzisa kukura kwavo kwekiriniki uye maitiro ekubvumidzwa.

Nezve IBI363 (Inonzi first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein))

IBI363 mushonga wekutanga mukirasi yakagadzirwa yakazvimirira neInnovent Biologics. Iprotein yePD-1/IL-2 bispecific antibody fusion yakagadzirirwa kuwedzera kushanda zvakanaka uku ichideredza chepfu. IL-2 arm yeIBI363 yakagadzirwa kuti iwedzere mhedzisiro yekurapa nekuderedza mhedzisiro, ukuwo PD-1 binding arm ichigonesa PD-1 blockade uye selective IL-2 delivery. Nekudzivisa PD-1/PD-L1 pathway uye kuvhura IL-2 pathway, IBI363 inobatsira kutarisa uye kushanda kwemasero eT chaiwo ane bundu. Zvidzidzo zve preclinical zvakaratidza kuti IBI363 inoratidza kushanda kwakasimba kwekurwisa bundu mumamodheru akawanda ane bundu, kusanganisira ayo anodzivirira PD-1 inhibitors nemamodheru ane metastatic. Pamusoro pezvo, yakaratidza kuchengetedzeka kwakanaka mumamodheru e preclinical. Miedzo yekiriniki iri kuitwa pari zvino muChina, United States, neAustralia kuti vaongorore kuchengetedzeka kwayo, kushivirira uye kushanda kwayo kwekutanga kune vanhu vane bundu repamusoro.

Pamusangano weWorld Conference on Lung Cancer (WCLC) munaGunyana 2024, IBI363 yakaratidza zviratidzo zvinovimbisa kushanda zvakanaka kwevarwere vane sqNSCLC vakambogamuchira immunotherapy:

Muboka re3 mg/kg dose, pakati pevarwere vane mavhiki gumi nemaviri ekutevera kana kupedza kudzidza (n=18), chiyero chekupindura chakanangana (ORR) chaive 50.0%, uye chiyero chekudzora chirwere (DCR) chaive 88.9%. Avhareji yehupenyu husina kuenderera mberi (PFS) haisati yasvika uye ichiri pasi pekutevera.

Muboka re1/1.5 mg/kg dose, avhareji yePFS yaive mwedzi 5.5 (95% CI: 1.5, 8.3), ine mwero wePFS wemwedzi gumi nemiviri we30.7%, zvichiratidza mabhenefiti angangovepo kwenguva refu ekurapa nekudzivirira muviri.

Mumapoka ese e1/1.5/3 mg/kg, varwere vane PD-L1 TPS<1% (n=22) uye avo vane PD-L1 TPS≥1% (n=22) vakawana maORR anokurudzira e36.4% uye 31.8%, zvichiteerana, zvichiratidza mukana weBI363 muhuwandu hwevanhu vane PD-L1 low expression.

Nezve Squamous Non-Small Cell Lung Cancer (sqNSCLC)

Gomarara remapapu ndiro chirwere chegomarara chinowanzoitika uye chinouraya pasi rose, kusanganisira muChina [1], zvichikonzera dambudziko guru rehutano hwevanhu. Gomarara remapapu risiri remasero madiki (NSCLC) rinobata vanhu vanopfuura 80% yezvirwere zvegomarara remapapu [2], negomarara remasero madiki riri rimwe remhando mbiri dzaro huru [2]. Mumakore achangopfuura, mishonga inodzivirira immune checkpoint yakachinja nzira yekurapa NSCLC. Zvisinei, kune varwere vane NSCLC vakakundikana immunotherapy uye vasina shanduko dzemajini, pachine chikonzero chakakosha uye chekukurumidzira chesarudzo dzekurapa dzinoshanda. Kurapa kwechipiri kana chechitatu, docetaxel, kunopa kushanda kushoma, nepakati pekugara pasina progression-free survival (PFS) kwemwedzi isingasviki mina [3], [4]. Kunyange zvazvo antibody-drug conjugates (ADCs) dzakaratidza kuvimbisa, zvidzidzo zviviri zvikuru zvePhase 3 muNSCLC yegomarara hazvisati zvaratidza kushanda kunogutsa.

Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.

Nhamba yefoni: 4008803716

Email：myimmnet@163.com

Mareferensi

1.Innovent (innoventbio.com)

2.MA11.04 First-in-Class PD-1/IL-2 Bispecific Antibody IBI363 Muvarwere vane Advanced Non-Small Cell Lung Cancer muChidzidzo Chechikamu Chekutanga - ScienceDirect