Mushonga Mutsva Wekushandisa kweDiki Cell Lung Cancer Inogamuchirwa

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Shanghai Henlius Biotech, Inc. yakazivisa kuti New Drug Application (NDA) yeHANSIZHUANG (serplulimab), inova anti-PD-1 monoclonal antibody (mAb) yakazvimiririra yakagadziridzwa nekambani, pamwe chete nekemotherapy yekurapwa kwemutsara wekutanga. yakakura nhanho yekenza yemapapu diki (ES-SCLC) yakagamuchirwa neNational Medical Products Administration (NMPA). Henlius anorongawo kuisa MAA muEU muna 2022. Hapana PD-1 yakatenderwa pasi rose kurapwa kweSCLC kusvika parizvino uye HANSIZHUANG angangoita PD-1 inhibitor yekutanga pasi rose kurapwa kweSCLC.

Muzvinafundo Ying Cheng, mukuru anoongorora chidzidzo ichi, Director weJilin Dhipatimendi reMedical Oncology Cancer Center, Jilin Province Lung Cancer Diagnosis and Treatment Center, uye Jilin Cancer Hospital Malignant Tumor Clinical Research Integrated Diagnosis and Treatment Center, vakati, “ASTRUM-005. ndiyo yekutanga uye yakakura ES-SCLC yepasirese yakawanda-center kiriniki yekudzidza inotungamirwa nevatsvagiri veChinese ve-anti-PD-1 mAb. Mhedzisiro yekiriniki yakanaka yakaratidza kuti iyo yakafanotsanangurwa yekutanga yekupedzisira yekupedzisira yaive yasvikwa, ichipa humbowo hwekuchengetedza uye kushanda. Isu tiri kutarisira kuti kubvumidzwa kweHANSIZHUANG kurapwa kweES-SCLC kunouya nekukurumidza kuzogadzirisa gaka uye kuunza nzira nyowani yekurapa kuvarwere vanogara neES-SCLC. “

VaJason Zhu, Mutungamiri weHenlius, vakati, "HANSIZHUANG inyanzvi yemAb yakazvimiririra yakagadziridzwa naHenlius, uye SCLC ndiyo chiratidzo chechitatu icho NDA yakagamuchirwa neNMPA uye Orphan-Drug Designation ichangobva kupihwa neUnited States. Food and Drug Administration (FDA). Zvichienderana nenhamba huru yezvido zvekiriniki zvisina kuzadziswa pamwe negomarara risingarasikike pasi rose neChina, kambani iyi yaisa nzira yakakwana yekurapa kenza yemapapu ine akawanda-pakati Phase 3 kiriniki miedzo. Kuenderera mberi, tichasimudzira musanganiswa immunotherapy yeHANSIZHUANG uye tsvakiridzo yekiriniki, zvichizobatsira varwere vazhinji muChina nepasirese.

HANSIZHUANG inovandudza zvakanyanya kupona kwese uye inozadza gap mukudiwa kwevarwere vane SCLC

Duku rekenza yemapapu (SCLC) inoverengera 15% -20% yezviitiko zvese uye ndiyo inonyanya hutsinye mhando yekenza yemapapu (LC). Inokamurwa kuita nhanho mbiri: nhanho shoma (LS-SCLC) uye ES-SCLC, iine zvese zvinoratidzira hutsinye hwakanyanya, kupindira kwakasimba, kutanga metastasis, kukurumidza kufambira mberi kwechirwere, uye kufungidzira kwakashata. Parizvino, anti-PD-L1 mAb yakasanganiswa nechemotherapy yakakurudzirwa neazvino NCCN nhungamiro uye CSCO nhungamiro semutsetse wekutanga kurapwa kweES-SCLC. Mumakore achangopfuura, zvakadaro, akati wandei ePD-1 mAbs akakundikana munzvimbo iyi.

Iyo NDA yakavakirwa pane zvakabuda kubva ku randomised, double-blind, international, multi-centre, phase 3 clinical study (ASTRUM-005) ine chinangwa chekuenzanisa kushanda nekuchengetedzeka kweHANSIZHUANG ne placebo kana yasanganiswa nechemotherapy (carboplatin-etoposide). ) muvarwere vakanga vasina kurapwa kare vane ES-SCLC. Ichi chidzidzo chakagadzira nzvimbo dze128 muChina, Turkey, Poland, Georgia, nezvimwewo uye zvidzidzo zve585 zvakanyoreswa, pakati pavo 31.5% vaive Caucasian. Muna Zvita 2021, ASTRUM-005 yakange yasangana neyayo yekutanga magumo ekupona kwese (OS) mune yenguva yekuongorora mhinduro. Mhedzisiro yezvidzidzo yakaratidza kuti HANSIZHUANG inogona kuwedzera zvakanyanya OS kusvika kumwedzi gumi neshanu nesere kuboka reHANSIZHUANG, ichidzikisa njodzi yerufu ne15.38% (38% muAsia subgroup) inogoneka kuchengetedza nhoroondo. Iyo data yekiriniki yepasirese inoisa hwaro hwakasimba hwemangwana manyorerwo pasirese.

China ine chiitiko chepamusoro cheLC, uye HANSIZHUANG inotarisirwa seyekutanga-mutsara wekurapa sarudzo kune ese madiki eLC.

Sekureva kweGLOBOCAN 2020, LC ndiyo yechipiri yakajairika gomarara pasirese. Paive nemamiriyoni mazana maviri nemazana maviri emakesi eLC pasi rese, neChina ichiverengera miriyoni 2.2 makesi matsva eLC. Zvakare, nekufa kutsva miriyoni 0.8 muna 1.8, LC ndiyo iri kukonzera kufa kwegomarara pasi rose. Isiri diki-diki kenza yemapapu (NSCLC) inosvika makumi masere neshanu muzana pakati peLC, ine squamous isiri-diki cell cancer yemapapu (sqNSCLC) inoverengera makumi matatu muzana. Vazhinji varwere vekenza yemapapu vanoonekwa padanho repamusoro uye vanoshaya mukana wekuvhiyiwa resection. Kuuya kwe immune checkpoint inhibitors kwakaratidza kuunza tariro kune varwere vane LC.

Henlius akaita yakazara yekutanga-mutsara immune-oncology kurapwa marongero eLC musqNSCLC, isiri-squamous isiri diki cell cancer cancer (nsNSCLC), ES-SCLC, uye LS-SCLC. NezveNSCLC, kambani iyi yakaita ongororo yakasarudzika, yakapetwa kaviri, yepasirese yakawanda-pakati Phase 3 yekiriniki muvarwere vane munharaunda yepamusoro kana metastatic sqNSCLC varwere kuenzanisa HANSIZHUANG pamwe chete nechemotherapy maringe nekemotherapy maererano nekubudirira uye kuchengetedzeka. Iyo NDA yakagamuchirwa semugumisiro wekudzidza kusangana nemagumo ekutanga. Zvakare, chidzidzo chekuongorora maviri maAbs musanganiswa kurapa kweHANSIZHUANG neHANBEITAI (bevacizumab) yekurapa-mutsara we nsNSCLC yapinda muchikamu chakakosha cheChitatu. Kune SCLC, kune rimwe divi, iyo yekuferefeta nyowani mushonga application (IND) yepasi rose multicenter chikamu 3 zvidzidzo zveHANSIZHUANG muvarwere vane LS-SCLC yakabvumidzwa neNMPA kuwedzera kune ASTRUM-3 yekurapwa kweES-SCLC. Zvinonyanya kukosha, FDA yakapa Nherera-Drug Dhizaini yeHANSIZHUANG yekurapwa kweSCLC, zvichibatsira kuenderera mberi kweHANSIZHUANG uye kunakidzwa kwerumwe rutsigiro rwepolicy maererano nekunyoresa uye kutengeserana muUnited States.

Mune ramangwana, kambani icharamba ichisimbisa zvisingaite zvekiriniki zvinodiwa uye nekushingaira kusimudzira musanganiswa immunotherapy weHANSIZHUANG uye kunyoreswa kwemitemo yepasirese kubatsira varwere vazhinji pasi rese.

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Avatar of Linda Hohnholz

Linda Hohnholz

Editor mukuru we eTurboNews yakavakirwa muTN HQ.

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