Ngomhla wesi-4 kweyoMnga, ngo-2024, iSicelo seMithi emitsha (NDA) sokudityaniswa kwe-TYVYT® (isitofu se-sintilimab) kunye ne-ELUNATE® (fruquintinib) sinikwe imvume emiselweyo eTshayina yokunyanga izigulane ezinomhlaza we-endometrial ophucukileyo ezineethumba ze-Mismatch Repair proficient (pMMR) eziye zasilela kunyango lwangaphambili lwenkqubo kwaye ezingezizo iingcali zonyango okanye i-radiation. Olu vumo lulandela imeko yophononongo oluphambili kunye nokukhethwa konyango oluphambili yi-National Medical Products Administration (NMPA) yaseTshayina kwaye luphawula uphawu lwesibhozo oluvunyiweyo lwe-TYVYT® (isitofu se-sintilimab).
Ukuvunywa okuxhomekeke kwimiqathango yi-NMPA kuxhaswe yidatha yesigaba sobhaliso evela kwi-FRUSICA-1, iqela lokubhalisa umhlaza we-endometrial lesifundo seSigaba sesi-2 esinamaziko amaninzi, esivulelekileyo esiphanda i-sintilimab kunye ne-fruquintinib kwizigulane zomhlaza we-endometrial eziye zafumana ukuphinda kwesifo, ukuqhubela phambili kwesifo okanye ubuthi obungenakunyamezelwa ngonyango lwe-chemotherapy esekwe kwi-platinum. Iziphumo ezivela kwi-FRUSICA-1 zaboniswa kwintlanganiso yonyaka ye-American Society of Clinical Oncology ngoJuni 2024.
AInani elipheleleyo lama-pMMR angama-98 anesimo se-pMMR abhalisiwe kwaye afumana unyango oludibeneyo. Zonke ii-pts ngaphambili zazifumene ubuncinane unyango lokuqala olune-platinum, kwaye ama-22.4% ee-pts afumene unyango lwe-bevacizumab. Imbali yesifo eneenkcukacha ishwankathelwe kwitheyibhile. Ngexesha lokulandelela eliphakathi (95% CI) le-15.7m (14.6, 17.7), ama-pts angama-87/98 ayenesiphumo esinye ubuncinane sovavanyo lwe-tumor emva kwesiseko (ii-pts ezivavanywayo), phakathi kwazo, i-ORR kunye ne-DCR ezivavanyiweyo yi-IRC yayiyi-35.6% (CR: 2/87 kunye ne-PR: 29/87) kunye ne-88.5% ngokulandelelana; i-DoR ayifikelelwanga kwaye izinga le-9m-DoR lalingama-80.7%. Phakathi kwama-pts angama-98, i-median (95% CI) PFS kunye ne-OS yayiyi-9.5m (5.6, -) kunye ne-21.3m (17.3, -) ngokwahlukeneyo. Ngokusekelwe kunyango lwangaphambili lwe-bevacizumab, i-ORR yayiyi-40.9% xa ithelekiswa ne-30.3%, kwaye i-median (95% CI) PFS yayiyi-13.8m (4.1, -) xa ithelekiswa ne-9.5m (5.5, -).
Iziganeko ezimbi ziyafana nezo zixeliweyo zonyango olufanayo lwe-immunotherapy kunye ne-antiangiogenic agents.
Malunga neSintilimab
I-Sintilimab, ethengiswa njenge-TYVYT (isitofu se-sintilimab) eTshayina, yi-PD-1 immunoglobulin G4 monoclonal antibody eyenziwe yi-Innovent kunye ne-Eli Lilly and Company. I-Sintilimab luhlobo lwe-immunoglobulin G4 monoclonal antibody, ebopha kwiimolekyuli ze-PD-1 kumphezulu wee-T-cells, ivale indlela ye-PD-1 / PD-Ligand 1 (PD-L1), kwaye ivuselele ii-T-cells ukubulala iiseli zomhlaza. ETshayina, i-sintilimab ivunyiwe kwaye ifakiwe kwi-NRDL ehlaziyiweyo kwiimpawu ezisixhenxe. Ububanzi bokubuyiselwa kwe-NRDL obuhlaziyiweyo be-TYVYT (isitofu se-sintilimab) buquka:
Kunyango lwe-relapse okanye refractory classic Hodgkin's lymphoma emva kwe-systemic chemotherapy imigca emibini okanye kamva;
Kunyango lokuqala lomhlaza wemiphunga ongengowesikweli ophucukileyo okanye ongengowesikweli ongengowesikweli ongenayo i-EGFR okanye i-ALK driver mutations;
Unyango lwezigulane ezine-EGFR-mutated local advanced okanye metastatic non-squamous non-small cell lung cancer eziqhubele phambili emva konyango lwe-EGFR-TKI;
Kunyango lokuqala lomhlaza wemiphunga ongekho small cell ongenakunyangwa kwindawo oqhubekekayo okanye osasazekayo;
Kunyango lokuqala lwe-carcinoma yesibindi engasuswayo okanye esasazekayo ngaphandle konyango olucwangcisiweyo ngaphambili;
Kunyango lokuqala lwe-carcinoma ye-squamous cell carcinoma engasuswayo ekwindawo ephucukileyo, ephindaphindayo okanye esasazekayo;
Kunyango lokuqala lwe-adenocarcinoma yesisu okanye ye-gastroesophageal junction engasuswayo ekwindawo ephucukileyo, ephindaphindayo okanye esasazekayo.
Ngaphezu koko, uphawu lwesibhozo lwe-sintilimab, kunye ne-fruquintinib yokunyanga izigulane ezinomhlaza we-endometrial oqhubele phambili kunye neethumba ze-pMMR eziye zasilela kunyango lwangaphambili lwenkqubo kwaye ezingezizo iingcali zotyando lokunyanga okanye imitha, lwavunywa yi-NMPA ngoDisemba 2024.
Ukongeza, izifundo ezimbini zeklinikhi ze-sintilimab zifezekisile iinjongo zazo eziphambili:
Isifundo seSigaba sesi-2 se-sintilimab monotherapy njengonyango lwesibini lwe-esophageal squamous cell carcinoma;
Isifundo seSigaba sesi-3 se-sintilimab monotherapy njengonyango lwesibini lomhlaza wemiphunga ongengowe-squamous non-small cell kunye nokuqhubela phambili kwesifo emva kwe-chemotherapy esekelwe kwi-platinum.
Malunga neFruquintinib
I-Fruquintinib sisithinteli somlomo esikhethiweyo kuzo zonke ii-receptors ezintathu ze-vascular endothelial growth factor (“VEGF”) (VEGFR-1, -2 kunye ne-3). Izithinteli ze-VEGFR zidlala indima ebalulekileyo ekuthinteleni i-tumor angiogenesis. I-Fruquintinib yenzelwe ukuba ibe nokukhetha okuphuculweyo okunciphisa umsebenzi we-kinase ongekho kwithagethi, okuvumela ukuvezwa kweziyobisi okufezekisa ukuthintelwa okuqhubekekayo kunye nokuguquguquka kokusetyenziswa okunokwenzeka njengenxalenye yonyango oludibeneyo.
I-Fruquintinib ivunyiwe ukuba ithengiswe kunyango lwezigulane ezinomhlaza we-colorectal osasazekayo ezikhe zafumana i-fluoropyrimidine, i-oxaliplatin kunye ne-irinotecan-based chemotherapy ngaphambili, kunye nabo bakha bafumana okanye abafanelekanga ukufumana unyango lwe-anti-VEGF okanye unyango lwe-anti-epidermal growth factor receptor (“EGFR”) (RAS wild-type) eTshayina, apho iphuhliswe kwaye ithengiswa kunye yi-HUTCHMED kunye ne-Eli Lilly and Company phantsi kwegama le-ELUNATE. Yafakwa kwi-China National Reimbursement Drug List (“NRDL”) ngoJanuwari 2020. Ukususela oko yaqaliswa eTshayina, izigulane ezingaphezu kwe-100,000 ezinomhlaza we-colorectal zinyangwe nge-fruquintinib.
NgoDisemba ka-2024, i-fruquintinib yavunywa yi-NMPA kunye ne-sintilimab kunyango lwezigulane ezinomhlaza we-endometrial oqhubele phambili kunye neethumba ze-pMMR eziye zasilela kunyango lwangaphambili lwenkqubo kwaye ezingezizo iingcali zotyando lokunyanga okanye ukusasazeka kwemitha.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-imeyile：myimmnet@163.com
Iireferensi
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
Ixesha leposi: Disemba-16-2024