IBI343 (CLDN 18.2 ADC) yakabatanidzwa semushonga wekurapa unobudirira neNational Medical Products Administration wekurapa varwere vepancreatic ductal adenocarcinoma vane chirwere chekenza chepancreatic.

Musi wa8 Ndira, Center for Drug Evaluation (CDE) yeNational Medical Products Administration (NMPA) yeChina yakapa Breakthrough Therapy Designation (BTD) yeIBI343, mushonga unonyanya kushandiswa pakurapa CLDN18.2 ADC, semushonga mumwe chete wekurapa varwere veCLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC) avo vakafambira mberi mushure mekurapwa kamwe chete.

BTD yeIBI343 yakapihwa zvichibva padata kubva kuongororo iri kuitwa muchikamu chekutanga chedzidzo yakaitwa muChina, Australia neUS (NCT05458219), iyo yakaratidza kuchengetedzeka kwakanaka uye kushivirira, pamwe nekubudirira kweIBI343 monotherapy muvarwere vane PDAC yepamusoro. Data kubva kuboka rekuwedzera kwedosi redzidzo iyi rakataurwa nemuromo pa2024 ESMO Asia Congress:

Kubva musi wa6 Gunyana, 2024, varwere vanosvika makumi mana nevatatu vane CLDN18.2-positive (≥60% bundu remasero ane kutsvuka kweganda ≥1+ neIHC) advanced PDAC vakagamuchira IBI343 6 mg/kg Q3W monotherapy. Vese vakatora chikamu vakambogamuchira kanenge ka1 mutsetse wekurapwa kare, uye 60.5% vakange vagamuchira 2 kana kupfuura mutsetse wekurapwa kwekenza.

Varwere makumi mana nevatatu vakaongororwa kushanda zvakanaka kwemishonga iyi, iyo yairatidza kuti panenge paine mhinduro chaiyo (ORR) ye32.6%, iyo yakasimbiswa kuti pane mhinduro chaiyo (cORR) ye23.3%, uye iyo yakasimbiswa kuti pane chirwere (cDCR) ye81.4%.

Sezvo zuva rekupedzisira redata, varwere vana pagumi ve cORR vakanga vafambira mberi, nguva yepakati yekupindura (mDoR) yaive mwedzi 7.0 (4.0-NC), uye mwero weDoR wemwedzi mitanhatu waiva 63%. Varwere makumi maviri nevatanhatu vakasangana nezviitiko zvePFS, nepakati pemwedzi isina progression-free survival (mPFS) ye5.3 (4.1-7.4), uye data reOS harisati rakura.

Mhedzisiro yekuchengetedzeka yakagadziridzwa yakaratidza kuchengetedzeka kwakanaka kweIBI343 nehuwandu hwakaderera hwekukuvadzwa mudumbu uye pasina zviratidzo zvitsva zvekuchengetedza. 97.7% yevatori vechikamu vakasangana nezviitiko zvakaipa zvekurapa (TEAEs), neTEAEs dzakajairika dziri kupererwa neropa, huwandu hwema neutrophil hwakaderera, kudzikira kwechido chekudya, kuda kurutsa, uye huwandu hwemasero machena eropa hwakaderera. 51.2% yevatori vechikamu vakasangana neTEAEs dzegiredhi rechitatu, uye hapana kuda kurutsa uye kurutsa kwegiredhi rechitatu kwakaitika. Hapana TEAE yakakonzera rufu.

Nezve IBI343 (Anti-CLDN18.2 ADC)

IBI343 imushonga wekudzivirira chirwere chemuviri wemunhu unodzivirira CLDN18.2 monoclonal antibody-drug conjugate (ADC) wakagadzirwa neInnovent Biologics. IBI343 inosungana nemasero egomarara anoburitsa CLDN18.2, CLDN18.2 dependent ADC internalization ichaitika uye mushonga wacho unoburitswa zvichikonzera kukuvara kweDNA uye pakupedzisira apoptosis yemasero egomarara. Mushonga wakasununguka unogona zvakare kupararira neplasma membrane kuti usvike nekuuraya masero ari pedyo, zvichikonzera "kuuraya kwevasingaoni".

Semushonga mutsva weTOPO1i ADC, IBI343 yakaratidza kuchengetedzeka kunoshivirira uye kukurudzira zviratidzo zvinoshanda muzvidzidzo zvekiriniki zveChikamu 1. Kugona kwekurapa kweIBI343 kuri kuongororwa pari zvino mumhando dzemabundu akadai sekenza yemudumbu nepancreatic.

Muna Chivabvu 2024, National Medical Products Administration (NMPA) yeChina yakapa IBI343 mushonga wekurapa unonzi Breakthrough Therapy (BTD) semushonga mumwe chete kuvarwere vane CLDN18.2–positive gastric or gastroesophageal junction (GEJ) adenocarcinoma avo vakasangana nechirwere ichi mushure mekurapwa kaviri kekutanga. Muedzo wePhase 3 (NCT06238843) weIBI343 wechiratidzo ichi uri kuenderera mberi.

Muna Chikumi 2024, IBI343 yakagamuchira Fast Track Designation neUS Food and Drug Administration (FDA) yekurapa chirwere chepancreatic ductal adenocarcinoma (PDAC) chisina kubviswa kana kuti chakapararira, icho chakadzokera shure uye/kana kuti hachina simba rekurapa. Kuedzwa kwechikamu chimwe chete (NCT05458219) kweIBI343 kwePDAC yakamborapwa kuri kuenderera mberi.

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://cn.innoventbio.com/#/

3.132MO Anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 muvarwere (pts) vane advanced pancreatic ductal adenocarcinoma (PDAC): Zvakagadziriswa kubva muchidzidzo chechikamu chekutanga - Annals of Oncology