Disemba 04, 2024, i-New Drug Application (NDA) yokuhlanganiswa kwe-TYVYT® (isijovo se-sintilimab) kanye ne-ELUNATE® (fruquintinib) inikezwe imvume enemibandela eShayina yokwelapha iziguli ezinomdlavuza we-endometrial othuthukisiwe ezinezimila ze-Mismatch Repair proficient (pMMR) eziye zahluleka ukwelashwa kwesistimu ngaphambilini futhi ezingezona iziguli ezizohlinzwa noma ezizosebenzisa imisebe. Lokhu kuvunyelwa kulandela isimo sokubuyekezwa okubalulekile kanye nokuqokwa kokwelashwa okuphumelelayo yi-National Medical Products Administration (NMPA) yaseShayina futhi kuphawula isibonakaliso sesishiyagalombili esivunyelwe se-TYVYT® (isijovo se-sintilimab).
Ukuvunyelwa okunemibandela yi-NMPA kwasekelwa idatha yesigaba sokubhalisa evela ku-FRUSICA-1, iqembu lokubhalisa umdlavuza we-endometrial lesifundo seSigaba sesi-2 esinezikhungo eziningi, esivulekile esiphenya i-sintilimab kanye ne-fruquintinib ezigulini zomdlavuza we-endometrial eziye zabhekana nokuphindaphinda kwesifo, ukuqhubeka kwesifo noma ubuthi obungabekezeleleki ngokwelashwa nge-chemotherapy esekwe ku-platinum. Imiphumela evela ku-FRUSICA-1 yethulwe emhlanganweni waminyaka yonke we-American Society of Clinical Oncology ngoJuni 2024.
AInani lama-pts angu-98 anesimo se-pMMR abhalisiwe futhi athola ukwelashwa okuhlanganisiwe. Bonke abahlinzayo babethole okungenani ukwelashwa kwesistimu okuqukethe i-platinum yomugqa wokuqala, kanti ama-pts angu-22.4% athole ukwelashwa kwe-bevacizumab. Imilando yesifo enemininingwane ifingqiwe etafuleni. Ngesikhathi sokulandelela esimaphakathi (95% CI) esingu-15.7m (14.6, 17.7), ama-pts angu-87/98 abe nomphumela okungenani owodwa wokuhlolwa kwesimila ngemuva kwesisekelo (ama-pts ahlolwayo ukusebenza kahle), phakathi kwawo, i-ORR ehlolwe yi-IRC kanye ne-DCR kwakungu-35.6% (CR: 2/87 kanye ne-PR: 29/87) kanye no-88.5% ngokulandelana; i-DoR ayifinyelelwanga kanti izinga le-9m-DoR lalingu-80.7%. Phakathi kwamaphoyinti angu-98, i-PFS ephakathi (95% CI) kanye ne-OS kwakuyi-9.5m (5.6, -) kanye ne-21.3m (17.3, -) ngokulandelana. Ngokusekelwe ekwelashweni kwangaphambilini kwe-bevacizumab, i-ORR yayiyi-40.9% uma kuqhathaniswa ne-30.3%, kanti i-PFS ephakathi (95%CI) yayiyi-13.8m (4.1, -) uma kuqhathaniswa ne-9.5m (5.5, -).
Izehlakalo ezimbi ziyahambisana nalezo ezibikiwe ngokwelashwa okufanayo kwe-immunotherapy kanye nemithi yokulwa ne-angiogenic.
Mayelana ne-Sintilimab
I-Sintilimab, ethengiswa njenge-TYVYT (umjovo we-sintilimab) eShayina, iyi-antibody ye-PD-1 immunoglobulin G4 monoclonal eyakhiwe ngokubambisana yi-Innovent no-Eli Lilly and Company. I-Sintilimab uhlobo lwe-antibody ye-immunoglobulin G4 monoclonal, ebopha kuma-molecule e-PD-1 ebusweni bama-T-cell, ivimbe indlela ye-PD-1 / PD-Ligand 1 (PD-L1), futhi ivuselele ama-T-cell ukubulala amaseli omdlavuza. EShayina, i-sintilimab ivunyiwe futhi ifakiwe ku-NRDL ebuyekeziwe yezinkomba eziyisikhombisa. Ububanzi bokubuyiselwa kwe-NRDL obubuyekeziwe be-TYVYT (umjovo we-sintilimab) buhlanganisa:
Ukwelashwa kwe-Hodgkin's lymphoma ephindaphindayo noma engaphikisi ngemuva kwe-chemotherapy ye-systemic imigqa emibili noma kamuva;
Ukwelashwa kokuqala komdlavuza wamaphaphu ongeyona i-squamous non-small cell ongasuswa endaweni noma osakazeke kalula ongenazo izinguquko zezakhi zofuzo eziqhutshwa yi-EGFR noma i-ALK;
Ukwelashwa kweziguli ezinomdlavuza wamaphaphu ongeyona i-squamous non-small cell oguquliwe endaweni noma osakazeke kalula, oqhubekele phambili ngemva kokwelashwa kwe-EGFR-TKI;
Ukwelashwa kokuqala komdlavuza wamaphaphu ongeyona iseli encane ongasuswa endaweni noma osakazeke kakhulu;
Ukwelashwa kokuqala kwe-carcinoma yesibindi engasuswa noma esakazeke kakhulu ngaphandle kokwelashwa okuhleliwe kwangaphambilini;
Ukwelashwa kokuqala kwe-carcinoma ye-squamous cell engasuswa endaweni ethuthukisiwe, ephindaphindayo noma esakazeka kalula;
Ukwelashwa kokuqala kwe-adenocarcinoma yesisu noma ye-gastroesophageal junction engasuswanga endaweni, ephindaphindayo noma esakazekile.
Ngaphezu kwalokho, isibonakaliso sesishiyagalombili se-sintilimab, kanye ne-fruquintinib yokwelapha iziguli ezinomdlavuza we-endometrial othuthukile onezimila ze-pMMR eziye zahluleka ukwelashwa kwesistimu ngaphambilini futhi ezingezona izithameli zokuhlinzwa noma imisebe, savunywa yi-NMPA ngoDisemba 2024.
Ngaphezu kwalokho, izifundo ezimbili zezokwelapha ze-sintilimab zihlangabezane nemigomo yazo eyinhloko:
Ucwaningo lwesigaba sesi-2 lwe-sintilimab monotherapy njengokwelashwa kwesibili kwe-esophageal squamous cell carcinoma;
Ucwaningo lwesigaba sesi-3 lwe-sintilimab monotherapy njengokwelashwa komugqa wesibili komdlavuza wamaphaphu ongewona amaseli amancane kanye nokuqhubeka kwesifo ngemuva kwe-chemotherapy esekelwe ku-platinum.
Mayelana ne-Fruquintinib
I-Fruquintinib iyisithiyo somlomo esikhethiwe sazo zonke i-receptor ezintathu ze-vascular endothelial growth factor (“VEGF”) (VEGFR-1, -2 kanye ne-3). Izithiyo ze-VEGFR zidlala indima ebalulekile ekuvimbeleni i-angiogenesis yesimila. I-Fruquintinib yaklanywa ukuthi ibe nokukhetha okuthuthukisiwe okunciphisa umsebenzi we-kinase ongaphandle kwethagethi, okuvumela ukuchayeka kwemithi okufeza ukuvinjelwa okuqhubekayo kwethagethi kanye nokuguquguquka kokusetshenziswa okungenzeka njengengxenye yokwelashwa okuhlanganisiwe.
I-Fruquintinib ivunyelwe ukudayiswa ekwelapheni iziguli ezinomdlavuza we-colorectal osakazekile ezake zathola i-fluoropyrimidine, i-oxaliplatin kanye ne-chemotherapy esekelwe ku-irinotecan, kanye nalabo abake bathola noma abangafaneleki ukuthola ukwelashwa kwe-anti-VEGF noma ukwelashwa kwe-anti-epidermal growth factor receptor (“EGFR”) (RAS wild-type) eShayina, lapho ithuthukiswe futhi ithengiswa khona yi-HUTCHMED kanye ne-Eli Lilly and Company ngaphansi kwegama lomkhiqizo i-ELUNATE. Yafakwa ku-China National Reimbursement Drug List (“NRDL”) ngoJanuwari 2020. Selokhu yasungulwa eShayina, iziguli ezingaphezu kuka-100,000 ezinomdlavuza we-colorectal ziye zelashwa nge-fruquintinib.
NgoDisemba 2024, i-fruquintinib yavunyelwa yi-NMPA kanye ne-sintilimab ekwelapheni iziguli ezinomdlavuza we-endometrial othuthukile ezinezimila ze-pMMR eziye zahluleka ukwelashwa kwesistimu ngaphambilini futhi ezingezona izithasiselo zokuhlinzwa noma zokukhishwa kwemisebe.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
I-imeyili：myimmnet@163.com
Izinkomba
1.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241203153537120.html
2.https://cn.innoventbio.com/#/news/592
3.https://meetings.asco.org/abstracts-presentations/234546
4.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5619
5.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5619
Isikhathi sokuthunyelwe: Disemba 16-2024