Pa 21 Marichi, 2025, Junshi Biosciences idalengeza kuti National Medical Products Administration (“NMPA”) yavomereza kugwiritsa ntchito mankhwala atsopano ("sNDA") pa mankhwala a kampaniyo, toripalimab, pamodzi ndi bevacizumab pochiza odwala omwe sachira kapena omwe ali ndi khansa ya chiwindi (“HCC”).
Kuvomerezedwa kwa NDA kowonjezera kumachokera ku deta yochokera ku kafukufuku wa HEPATORCH (NCT04723004), womwe ndi kafukufuku wachipatala wa magawo atatu osiyanasiyana, wosasankhidwa mwachisawawa, wotseguka, komanso wolamulidwa ndi anthu ambiri. Pulofesa Jia FAN, katswiri wa maphunziro a Chinese Academy of Sciences, wochokera ku Zhongshan Hospital yogwirizana ndi Fudan University, anali wofufuza wamkulu. HEPATORCH idayambitsidwa m'zipatala 57 ku China, Taiwan ndi Singapore ku China, ndipo odwala 326 onse adalembetsa. Kafukufukuyu cholinga chake chinali kuwunika momwe toripalimab imagwirira ntchito limodzi ndi bevacizumab pochiza HCC yosachira kapena yofalikira m'thupi poyerekeza ndi chithandizo chokhazikika cha sorafenib.
Mu Seputembala 2024, zotsatira za kafukufuku wa HEPATORCH zinayamba kuonekera pa Msonkhano wa 27 wa National Clinical Oncology ndi Msonkhano Wapachaka wa 2024 wa Chinese Society of Clinical Oncology (CSCO). Zotsatira za kafukufukuyu zinasonyeza kuti mapeto oyamba, kupulumuka kopanda kupita patsogolo ("PFS," kutengera ndemanga yodziyimira payokha ya radiographic) ndi OS, zonse zinapeza zotsatira zabwino.
HEPATORCH inasonyeza kuti poyerekeza ndi sorafenib, toripalimab pamodzi ndi bevacizumab zitha kukulitsa kwambiri PFS ndi OS ya odwala, ndi PFS yapakati ya miyezi 5.8 poyerekeza ndi miyezi 4.0, kuchepetsa chiopsezo cha kupita patsogolo kwa matenda kapena imfa ndi 31% (chiŵerengero cha zoopsa [HR] = 0.69, 95% CI: 0.525-0.913; P = 0.0086), ndi OS yapakati ya miyezi 20.0 poyerekeza ndi miyezi 14.5, ndikuchepetsa chiopsezo cha imfa ndi 24% (HR = 0.76, 95% CI: 0.579-0.987; P = 0.0394). Chiŵerengero cha mayankho olondola ("ORR") cha gulu la toripalimab ndi bevacizumab chinali chokwera kwambiri kuposa cha gulu la sorafenib. ORR ya magulu awiriwa inali 25.3% ndi 6.1%, motsatana. Kuphatikiza apo, mankhwala ophatikizana ali ndi mbiri yabwino yachitetezo kwa odwala omwe ali ndi HCC yapamwamba. Kuchuluka kwa poizoni kumagwirizana ndi kuchuluka kwa poizoni komwe kumadziwika mu monotherapy yokhazikika, ndipo palibe chizindikiro chatsopano chachitetezo chomwe chapezeka.
About Toripalimab
Toripalimab ndi antibody yotsutsana ndi PD-1 monoclonal yomwe idapangidwa chifukwa cha kuthekera kwake kuletsa kuyanjana kwa PD-1 ndi ma ligands ake, PD-L1 ndi PD-L2, komanso kuyambitsa PD-1 receptor internalization (ntchito ya endocytosis). Kuletsa kuyanjana kwa PD-1 ndi PD-L1 ndi PD-L2 kumalimbikitsa mphamvu ya chitetezo cha mthupi kuukira ndi kupha maselo otupa.
Kafukufuku wopitilira makumi anayi wa toripalimab wothandizidwa ndi kampani womwe uli ndi zizindikiro zoposa khumi ndi zisanu wachitika padziko lonse lapansi ndi Junshi Biosciences, kuphatikiza ku China, United States, Europe ndi Southeast Asia. Mayeso azachipatala opitilira kapena omalizidwa omwe amayesa chitetezo ndi mphamvu ya toripalimab amakhudza mitundu yosiyanasiyana ya zotupa, kuphatikizapo khansa ya m'mapapo, m'mphuno, m'mero, m'mimba, chikhodzodzo, m'mawere, chiwindi, impso, ndi khungu.
Ku China, toripalimab inali antibody yoyamba ya anti-PD-1 monoclonal yovomerezeka kuti igulitsidwe (yovomerezedwa ku China ngati TUOYI®). Pakadali pano, pali zizindikiro khumi ndi chimodzi zovomerezeka za toripalimab ku China:
melanoma yosachira kapena yofalikira pambuyo poti chithandizo chamankhwala chokhazikika chalephera;
khansa ya m'mphuno yobwerezabwereza kapena yofalikira (NPC) pambuyo poti njira ziwiri zochiritsira zam'mbuyomu zalephera;
khansa ya urothelial yotsogola kapena yofalikira m'deralo yomwe sinagwire ntchito ya chemotherapy yokhala ndi platinum kapena yomwe idapitirira mkati mwa miyezi 12 ya chemotherapy yokhala ndi neoadjuvant kapena adjuvant platinum;
kuphatikiza ndi cisplatin ndi gemcitabine ngati chithandizo choyamba kwa odwala omwe ali ndi NPC yobwerezabwereza kapena yofalikira m'deralo;
kuphatikiza ndi paclitaxel ndi cisplatin pochiza odwala omwe ali ndi khansa ya squamous cell carcinoma (ESCC) yomwe singathe kuchiritsidwa mosavuta;
kuphatikiza ndi pemetrexed ndi platinum ngati chithandizo choyamba cha khansa ya m'mapapo ya non-squamous non-small cell (NSCLC) ya EGFR mutation-negative ndi ALK mutation-negative, yosachiritsika, yotsogola kapena yofalikira ya non-squamous non-small cell lung cancer (NSCLC);
kuphatikiza ndi chemotherapy ngati chithandizo cha perioperative ndipo pambuyo pake ndi monotherapy ngati chithandizo chothandizira pochiza odwala akuluakulu omwe ali ndi gawo la IIIA-IIIB NSCLC lotha kuchotsedwa;
pamodzi ndi axitinib pochiza odwala omwe ali ndi chiopsezo chapakati mpaka chachikulu chosachira kapena khansa ya impso yofalikira (RCC);
kuphatikiza ndi etoposide kuphatikiza platinum pochiza khansa ya m'mapapo ya maselo ang'onoang'ono (ES-SCLC);
kuphatikiza ndi paclitaxel kuti mupereke jakisoni (yomangidwa ndi albumin) pochiza khansa ya m'mawere yobwerezabwereza kapena yofalikira ya triple-negative (TNBC);
pamodzi ndi bevacizumab pochiza odwala omwe sachira kapena omwe ali ndi khansa ya chiwindi (HCC) yomwe imafalikira m'magazi.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Email：myimmnet@163.com
Nthawi yotumizira: Marichi-27-2025