Musi wa18 Kurume, 2025, Alphamab Oncology yakazivisa kuti anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 yakapihwa Breakthrough Therapy Designation neCenter for Drug Evaluation (CDE) yeNational Medical Products Administration (NMPA). Zita iri nderekurapa kenza ye ovarian cancer isingapindi platinum (PROC), kenza ye peritoneal cancer yekutanga, kana kenza ye fallopian tube, kwete chete pamazinga eHER2 expression.
Kupihwa kweBreakthrough Therapy Designation kwakavakirwa pakuongorora kwakabatanidzwa kwezvidzidzo zviviri zvekiriniki, JSKN003-101 naJSKN003-102. JSKN003-101 (NCT05494918) chidzidzo chekiriniki chePhase I chakavhurika, chine nzvimbo dzakawanda, chakakwidza dose chakaitwa muAustralia, chichinyoresa varwere vane bundu rakasimba repamusoro rinoratidza HER2 (IHC≥1+) kana vane HER2 mutations. JSKN003-102 (NCT05744427) chidzidzo chePhase I/II chakaitwa muChina. Chikamu chePhase I chakanyoresa varwere vane histologically confirmed HER2 expression (IHC≥1+) kana HER2 mutations advanced solid tumors. Chikamu chePhase II chakanyoresa varwere vane bundu rakasimba repamusoro pasinei neHER2 expression kana mamiriro ekuchinja.
Ruzivo rwekutanga kubva muongororo yakabatanidzwa yezvidzidzo zviviri izvi rwakaunzwa pa2024 European Society for Medical Oncology (ESMO) Congress.
Kubva musi wa15 Chikunguru 2024, varwere makumi mashanu vane PROC vakanga vagamuchira JSKN003 pamatanho mashanu emushonga, pakati pavo varwere vaviri vaiva ne4.2mg/kg, varwere vaviri vaiva ne5.2mg/kg, varwere makumi mana nevana vaiva ne6.3mg/kg, murwere mumwe chete aiva ne7.3mg/kg, uye murwere mumwe chete aiva ne8.4mg/kg. Pakati pevarwere makumi mashanu vakanyoreswa zvichibva pakuongororwa kwemurabhoritari, paive nevarwere gumi nevanomwe vane HER2 expression (IHC 1+, 2+ uye 3+) (varwere vaviri chete vane HER2 IHC 3+), varwere gumi nevanomwe vane IHC 0, uye varwere gumi nevatanhatu havana kuwana mhinduro dzeHER2 nekuti vakanga vasati vaongororwa musi wa15 Chikunguru. Varwere makumi maviri nevasere (56.0%) vakamborapwa katatu, varwere makumi matatu nevanomwe (74.0%) vakange varapwa nebevacizumab, uye varwere makumi maviri nevasere (56.0%) vakange varapwa nePARP inhibitor.
Nguva yepakati yekurapwa yaive mavhiki 12.4 (kubva pamavhiki 0.7 kusvika 51.0), nevarwere 32 (64.0%) vakaramba vari pakurapwa kusvika zuva rekupedzisira redata.
Kuchengetedzeka: Pakati pevarwere vese makumi mashanu vakanyoreswa, varwere vatatu vakasangana nechirwere chepakati pemapapu (ILD)/pneumonia. Varwere vashanu (10.0%) vakasangana nezviitiko zvakashata zvine chekuita nekurapwa (TRAEs) mugiredhi rechitatu, uye zvakanyanya kuitika ndezvemanyoka (2.0%) uye ane ropa shoma (2.0%). Hapana TRAEs dzakakonzera rufu.
Kushanda Nesimba: Pakati pevarwere makumi mana nevana vakaongororwa kushanda kwavo vakaongororwa kamwe chete mushure mekutanga kwechirwere chegomarara, chiyero chekupindura chakanangana (ORR) chaive 56.8%, nevarwere makumi matatu nevapfumbamwe (88.6%) vachiratidza kuderera kwegomarara. ORR muvarwere vane HER2 IHC 0 neHER2 expression (IHC 1+, 2+ ne3+) yaive 52.9% uye 68.8%, zvichiteerana. Kune varwere makumi matatu nevatatu vakagamuchira mushonga webevacizumab kare, ORR yaive 54.5%, kune varwere makumi maviri nevatanhatu vakagamuchira mushonga wePARP inhibitor kare, ORR yaive 46.2%.
Zvakawanikwa zvakaratidza kuti JSKN003 monotherapy ine mukana wekushivirira uye kuchengetedzeka, ine zviratidzo zvinovimbisa kushanda zvakanaka muvarwere vane PROC yepamusoro, uye kushanda zvakanaka kwakaonekwa kune varwere vane (IHC 1+/2+3+) kana vasina (IHC 0) HER2 expression, vane kana vasina bevacizumab uye PARP inhibitor yekare.
Nezve JSKN003
JSKN003 imushonga unodzivirira HER2 bispecific antibody-drug conjugate (bis-ADC), wakagadzirwa uchishandisa Alphamab's proprietary Glycan-specific conjugation platform. JSKN003 inogona kusunga HER2 pamusoro pemasero egomarara uye kuburitsa topoisomerase I inhibitors (TOPIi) kuburikidza nemasero e endocytosis, nokudaro iine mhedzisiro yekurwisa gomarara. Kana ichienzaniswa neADC, JSKN003 yakaratidza kugadzikana kuri nani muropa uye simba rakasimba rekutarisa, izvo zvinoita kuti pave neruzivo rwekurapa.
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. https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://www.alphamabonc.com/en/
Nguva yekutumira: Kurume-18-2025