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Phunziro Latsopano Lochiza Khansa ya M'mapapo Yavomerezedwa

Kafukufuku wachipatala wa Henlius'Phase 3 wa buku la PD-1 inhibitor serplulimab pochiza khansa ya m'mapapo yaing'ono yamtundu woyamba (ES-SCLC) amakumana ndi mathero oyambira.

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Shanghai Henlius Biotech, Inc. yalengeza kuti kusanthula kwakanthawi koyamba kunakwaniritsa mfundo yayikulu yopulumuka (OS) ya Phase 3 Clinical Study (NCT04063163) yaukadaulo wake wa PD-1 inhibitor serplulimab kuphatikiza ndi chemotherapy mwa odwala omwe sanalandire chithandizo. khansara yaing'ono ya m'mapapo ya m'mapapo (ES-SCLC). Palibe anti-PD-1 mAb yovomerezeka kuti azichiza khansa yaing'ono yam'mapapo yapadziko lonse lapansi (ES-SCLC).

Cholinga chachikulu cha phunziroli ndikuwunika mphamvu ndi chitetezo cha serplulimab kuphatikiza ndi chemotherapy mwa odwala omwe sanalandire chithandizo ndi ES-SCLC. Kutengera zotsatira za kusanthula kwakanthawi kofotokozedwa kochitidwa ndi Independent Data Monitoring Committee (IDMC), serplulimab kuphatikiza ndi chemotherapy idawonetsa kusintha kwakukulu mu OS motsutsana ndi chemotherapy, yomwe idakwaniritsa njira zodziwikiratu zogwira ntchito, zokhala ndi chitetezo chabwino komanso palibe. kuzindikira kwa chizindikiro chatsopano chachitetezo. IDMC inanena kuti kampaniyo ikhoza kuyankhulana ndi akuluakulu athanzi.

SCLC ndi yoopsa kwambiri, ndipo chithandizo chomwe chilipo ndi chochepa

Malinga ndi kafukufuku wa GLOBOCAN, khansa ya m'mapapo (LC) ndi khansa yachiwiri yomwe imapezeka padziko lonse lapansi ndipo imawerengera 11.4% ya khansa padziko lonse lapansi mu 2020. Akuti pali odwala 810,000 atsopano omwe ali ndi LC ku China mu 2020, ndipo LC ndi omwe adadwala khansa. zomwe zimayambitsa matenda a khansa ndi imfa. SCLC imakhala ndi 15% -20% pakati pa LC, ndipo ndi mtundu wovuta kwambiri wa LC, womwe umagawidwa m'magawo ochepa a khansa ya m'mapapo yaing'ono (LS-SCLC) ndi ES-SCLC. Odwala ambiri ali kale pamlingo wokulirapo akapezeka. Odwala omwe ali ndi ES-SCLC nthawi zonse amakhala ndi chotupa chofulumira kukula komanso kusazindikira bwino. Ena a iwo amakhala ndi moyo kwakanthawi kochepa chifukwa chakukula kwa chotupa komanso kusakhazikika kwa thupi kokha ndi chithandizo chothandizira.

Pazaka 20, etoposide kuphatikiza carboplatin/cisplatin akadali muyezo wa chisamaliro cha ES-SCLC, koma 80% ya odwala omwe ali ndi matenda ocheperako komanso pafupifupi odwala onse omwe ali ndi matenda ochulukirapo amabwereranso mkati mwa chaka chimodzi, ndi kupulumuka kwapakatikati kwa 4 mpaka Miyezi 5 mutayambiranso. Kutuluka kwa immune checkpoint inhibitors kumapereka njira yatsopano. Pakalipano, anti-PD-L1 mAb yophatikizidwa ndi chemotherapy yalimbikitsidwa ndi malangizo aposachedwa a NCCN ndi malangizo a CSCO monga chithandizo choyamba cha ES-SCLC. Komabe, kugwiritsa ntchito immunotherapy mu ES-SCLC kumakumanabe ndi zovuta. M'zaka zaposachedwa, ma PD-1 mAbs angapo alephera m'derali. Chifukwa chake, chithandizo chamzere choyambirira cha PD-1 inhibitors ndichofunika mwachangu.

Kukhazikika pazosowa zosakwanira za odwala, kuphimba chithandizo choyambirira cha mitundu yonse ya khansa ya m'mapapo

Henlius watengera njira yosiyana ya "Combo+Global" pa serplulimab. Pakadali pano, serplulimab yavomerezedwa kuti iyesedwe ku China, United States, European Union ndi mayiko ena ndi zigawo. Mayesero okwana 10 a mankhwala a immuo-oncology a serplulimab akupitilira kuyesa chitetezo chake ndi mphamvu zake mu zotupa zosiyanasiyana zolimba zomwe zimaphimba LC, hepatocellular carcinoma, esophageal carcinoma, mutu ndi khosi squamous cell carcinoma ndi khansa ya m'mimba ndi zina zotero. tsiku, pafupifupi 2300 odwala analembetsa padziko lonse, kutsimikizira kuti khalidwe la serplulimab wamanga chikhulupiriro m'misika yakunja. Mu Epulo, New Drug Application (NDA) ya serplulimab yochiza zotupa zolimba za MSI-H idavomerezedwa ndi National Medical Products Administration (NMPA) ndikuwunikanso patsogolo, zomwe zikuyembekezeka kuvomerezedwa mu theka loyamba la 2022.

Malinga ndi mawonekedwe a odwala khansa padziko lonse lapansi komanso ku China, kampaniyo imayang'ana kwambiri khansa ya m'mapapo ndi khansa ya m'mimba yokhala ndi serplulimab ngati msana. Henlius adakwaniritsa dongosolo lachipatala loyamba la LC, ndipo adayesa pa serplulimab ku sqNSCLC, khansa ya m'mapapo yopanda squamous yomwe siing'onoting'ono ndi SCLC, yophimba oposa 90% odwala khansa ya m'mapapo. Kutengera mayesero achipatala a Phase 3 osasinthika, akhungu awiri, ochokera kumayiko osiyanasiyana omwe adachitidwa mwa odwala omwe sanalandire chithandizo omwe anali ndi sqNSCLC, NDA ya serplulimab yochiza koyamba kwa sqNSCLC yotsogola kapena metastatic yavomerezedwa ndi NMPA. . M'tsogolomu, ndi zambiri zofufuza zachipatala zapadziko lonse lapansi, Henlius apitiriza kukulitsa kugawa kwa serplulimab padziko lonse ndikupindulitsa odwala ambiri padziko lonse lapansi.

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Ponena za wolemba

Linda Hohnholz, mkonzi wa eTN

Linda Hohnholz wakhala akulemba ndi kusintha zolemba kuyambira pomwe anayamba ntchito. Iye wagwiritsa ntchito chilakolako chobadwachi m'malo ngati Hawaii Pacific University, Chaminade University, Hawaii Children's Discovery Center, ndipo tsopano TravelNewsGroup.

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