Ukusetshenziswa Okusha Kwezidakamizwa Zomdlavuza Weseli Encane Wamaphaphu Kwamukelwe

A BAMBA MahhalaRelease 1 | eTurboNews | eTN
Isithombe sikaLinda Hohnholz
Ibhalwe ngu Linda Hohnholz

I-Shanghai Henlius Biotech, Inc. imemezele ukuthi i-New Drug Application (NDA) ye-HANSIZHUANG (serplulimab), inoveli elwa ne-PD-1 monoclonal antibody (mAb) eyakhiwe ngokuzimele yinkampani, ihlanganiswe ne-chemotherapy yokwelashwa komugqa wokuqala. Isigaba esibanzi somdlavuza wamaphaphu amancane (ES-SCLC) samukelwe yi-National Medical Products Administration (NMPA). U-Henlius futhi uhlela ukufaka i-MAA ku-EU ngo-2022. Ayikho i-PD-1 egunyazwe emhlabeni jikelele ukuze iphathwe ngomugqa wokuqala we-SCLC kusesikhathini futhi u-HANSIZHUANG okungenzeka abe yisivimbi sokuqala emhlabeni se-PD-1 sokwelashwa komugqa wokuqala we-SCLC.

USolwazi u-Ying Cheng, umphenyi oyinhloko walolu cwaningo, uMqondisi woMnyango we-Jilin Department of Medical Oncology Cancer Center, Isikhungo saseJilin Sokuxilonga Umdlavuza Wamaphaphu kanye Nesikhungo Sokwelapha Umdlavuza, kanye nesibhedlela iJilin Cancer Hospital Malignant Tumor Clinical Research Integrated Diagnosis and Treatment Center, uthe, “ASTRUM-005 iwucwaningo lokuqala nolwekhulukazi lwe-ES-SCLC lwamazwe ngamazwe olunezikhungo eziningi zomtholampilo oluholwa abacwaningi baseShayina be-anti-PD-1 mAb. Imiphumela emihle yomtholampilo ibonise ukuthi isiphetho socwaningo esichazwe ngaphambilini sase sifinyelelwe, sinikeza ubufakazi bokuphepha nokusebenza ngempumelelo. Siyethemba ukuthi ukugunyazwa kwe-HANSIZHUANG yokwelashwa kwe-ES-SCLC kuza maduze ukuze kulungiswe igebe futhi kulethe inketho yokwelashwa entsha ezigulini ezihlala ne-ES-SCLC. “

UMnu. Jason Zhu, uMongameli we-Henlius, uthe, “I-HANSIZHUANG iyi-mAb esungulwe ngokuzimele ngu-Henlius, futhi i-SCLC iyinkomba yesithathu lapho i-NDA yamukelwe yi-NMPA kanye ne-Orphan-Drug Designation esanda kunikezwa yi-United States. I-Food and Drug Administration (FDA). Ngokusekelwe enanini elikhulu lezidingo zomtholampilo ezingahlangatshezwana nazo kanye nomdlavuza ongalawuleki emhlabeni wonke naseShayina, inkampani isebenzise isu eliphelele lomugqa wokuqala wokwelapha umdlavuza wamaphaphu ngezivivinyo eziningi zomtholampilo zeSigaba sesi-3 ezitholakala ezindaweni eziningi. Ukuqhubekela phambili, sizokhuthaza ngokuqhubekayo inhlanganisela yokwelashwa kwe-immunotherapy ye-HANSIZHUANG kanye nocwaningo lomtholampilo, ngaleyo ndlela sizuzise iziguli eziningi eChina nasemhlabeni jikelele. "

I-HANSIZHUANG ithuthukisa kakhulu ukusinda okuphelele futhi igcwalise igebe lesidingo seziguli ezine-SCLC

Umdlavuza wamaphaphu omncane (SCLC) ubala u-15% -20% wazo zonke izimo futhi uwuhlobo olunolaka kakhulu lomdlavuza wamaphaphu (LC). Ihlukaniswe yaba izigaba ezimbili: isiteji esinqunyelwe (LS-SCLC) kanye ne-ES-SCLC, kokubili okubonisa ukonakala okuphezulu, ukuhlasela okunamandla, i-metastasis yokuqala, ukuqhubekela phambili kwezifo ngokushesha, kanye nokubikezela okubi. Njengamanje, i-anti-PD-L1 mAb ehlanganiswe nokwelashwa ngamakhemikhali iye yanconywa yiziqondiso zakamuva ze-NCCN nemihlahlandlela ye-CSCO njengokwelashwa komugqa wokuqala kwe-ES-SCLC. Eminyakeni yakamuva, nokho, inqwaba ye-PD-1 mAbs yehlulekile endaweni.

I-NDA isuselwe emiphumeleni yocwaningo lomtholampilo olungahleliwe, olungaboni kabili, lwamazwe ngamazwe, olumaphakathi, lwesigaba 3 (ASTRUM-005) oluhlose ukuqhathanisa ukusebenza kahle nokuphepha kwe-HANSIZHUANG ne-placebo uma kuhlanganiswa nokwelashwa ngamakhemikhali (carboplatin-etoposide). ) ezigulini ebezingazange zilashwe ngaphambilini ezine-ES-SCLC. Lolu cwaningo lusungule amasayithi angaba ngu-128 e-China, eTurkey, e-Poland, e-Georgia, njll. kanti izifundo ze-585 zabhaliswa, phakathi kwazo i-31.5% yayiyi-Caucasian. NgoZibandlela wezi-2021, i-ASTRUM-005 yayifinyelele isiphetho sayo esiyinhloko se-survival (OS) emiphumeleni yokuhlaziya yesikhashana. Imiphumela yocwaningo ibonise ukuthi i-HANSIZHUANG inganweba kakhulu i-OS ibe yizinyanga eziyi-15.38 eqenjini le-HANSIZHUANG, inciphise ingozi yokufa ngama-38% (41% eqenjini elincane lase-Asia) iphrofayili yokuphepha elawulekayo. Idatha yomtholampilo yomhlaba wonke yenza isisekelo esiqinile sezinhlelo zokusebenza zesikhathi esizayo emhlabeni jikelele.

I-China inezigameko eziphakeme kakhulu ze-LC, futhi i-HANSIZHUANG ihloswe njengenketho yokwelashwa yomugqa wokuqala kuzo zonke izinhlobo ezincane ze-LC.

Ngokusho kwe-GLOBOCAN 2020, i-LC ingumdlavuza wesibili ovame kakhulu emhlabeni jikelele. Bekunamacala amasha e-LC ayizigidi ezi-2.2 emhlabeni wonke, kanti i-China ibalwa namacala amasha e-LC ayizigidi eziyi-0.8. Ngaphezu kwalokho, ngokufa okusha okuyizigidi eziyi-1.8 ngo-2020, i-LC iyimbangela ehamba phambili yokufa komdlavuza emhlabeni jikelele. Umdlavuza wamaphaphu ongewona omncane (i-NSCLC) wenza cishe ama-85% phakathi kwe-LC, nomdlavuza we-squamous ongewona omncane wamaphaphu (sqNSCLC) ubalwa cishe ngama-30%. Iningi leziguli ezinomdlavuza wamaphaphu zitholwa zisezingeni eliphezulu futhi azinalo ithuba lokuhlinzwa. Ukufika kwama-immune checkpoint inhibitors kufakazelwe ukuthi kulethe ithemba ezigulini ezine-LC.

U-Henlius wenze uhlelo oluphelele lokwelashwa kwe-immune-oncology lomugqa wokuqala lwe-LC ku-sqNSCLC, umdlavuza wamaphaphu ongewona ama-squamous non-small cell lung (nsNSCLC), ES-SCLC, kanye ne-LS-SCLC. Ku-NSCLC, inkampani yenze uhlolo lwemitholampilo olungahleliwe, olungaboni kabili, olugxile emhlabeni wonke lweSigaba 3 somtholampilo ezigulini ezineziguli ze-sqNSCLC ezithuthuke kakhulu noma ezine-metastatic ukuze kuqhathaniswe i-HANSIZHUANG ngokuhambisana nokwelashwa ngamakhemikhali nechemotherapy maqondana nokusebenza kahle nokuphepha. I-NDA yamukelwe ngenxa yokuhlangana kocwaningo neziphetho eziyinhloko. Futhi, ucwaningo lokuhlola inhlanganisela yokwelapha ye-mAbs ekabili ye-HANSIZHUANG ne-HANBEITAI (bevacizumab) yokwelashwa komugqa wokuqala we-nsNSCLC lungene esigabeni sesi-3 esibalulekile. Ku-SCLC, ngakolunye uhlangothi, isicelo sesidakamizwa esisha sophenyo (IND) sezifundo zamazwe ngamazwe zesigaba sesi-3 se-HANSIZHUANG ezigulini ezine-LS-SCLC sigunyazwe yi-NMPA ngaphezu kwe-ASTRUM-005 yokwelashwa kwe-ES-SCLC. Ngokuphawulekayo, i-FDA inikeze i-HANSIZHUANG Isidakamizwa Sezidakamizwa Ukuqokwa Kwezintandane ukuze kulashwe i-SCLC, okuzuzisa ukuthuthukiswa okuqhubekayo kwe-HANSIZHUANG kanye nokujabulela ukusekelwa okuthile kwenqubomgomo mayelana nokubhaliswa nokudayisa e-United States.

Ngokuzayo, inkampani izoqhubeka nokugcizelela izidingo zomtholampilo ezingahlangatshezwana nazo futhi ikhuthaze ngenkuthalo inhlanganisela ye-immunotherapy ye-HANSIZHUANG kanye nokubhaliswa kokulawulwa kwamanye amazwe ukuze kuzuze iziguli eziningi emhlabeni jikelele.

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Isithombe sikaLinda Hohnholz

Linda Hohnholz

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