Thaum Lub Kaum Ob Hlis 04, 2024, Daim Ntawv Thov Tshuaj Tshiab (NDA) rau kev sib xyaw ua ke ntawm TYVYT® (sintilimab txhaj tshuaj) thiab ELUNATE® (fruquintinib) tau txais kev pom zoo hauv Suav teb rau kev kho mob rau cov neeg mob uas muaj mob qog nqaij hlav endometrial siab heev nrog Mismatch Repair proficient (pMMR) qog uas tau ua tsis tiav kev kho mob yav dhau los thiab tsis yog cov neeg sib tw rau kev phais mob lossis kev kho hluav taws xob. Kev pom zoo no ua raws li qhov xwm txheej tshuaj xyuas tseem ceeb thiab kev tsim kho tshiab los ntawm National Medical Products Administration (NMPA) ntawm Suav teb thiab cim qhov cim qhia yim pom zoo rau TYVYT® (sintilimab txhaj tshuaj).
Qhov kev pom zoo los ntawm NMPA tau txais kev txhawb nqa los ntawm cov ntaub ntawv theem sau npe los ntawm FRUSICA-1, pawg neeg sau npe mob qog noj ntshav endometrial ntawm ntau lub chaw, qhib-daim ntawv lo Theem 2 kev tshawb fawb tshawb nrhiav sintilimab ua ke nrog fruquintinib hauv cov neeg mob qog noj ntshav endometrial uas tau ntsib kev rov tshwm sim ntawm tus kab mob, kev nce qib ntawm tus kab mob lossis kev lom tsis zoo nrog kev kho mob ntawm platinum-based doublet chemotherapy. Cov txiaj ntsig los ntawm FRUSICA-1 tau nthuav tawm ntawm American Society of Clinical Oncology lub rooj sib tham txhua xyoo thaum Lub Rau Hli 2024.
Ibtag nrho ntawm 98 pts nrog pMMR xwm txheej tau sau npe thiab tau txais kev kho mob ua ke. Tag nrho cov pts tau txais tsawg kawg thawj kab platinum-muaj kev kho mob systemic, thiab 22.4% pts tau txais kev kho mob bevacizumab. Cov keeb kwm kab mob kom ntxaws tau muab sau ua ke hauv lub rooj. Nrog rau lub sijhawm nruab nrab (95% CI) kev saib xyuas ntawm 15.7m (14.6, 17.7), 87/98 pts muaj tsawg kawg ib qho kev ntsuam xyuas qog tom qab-baseline (kev ua tau zoo ntsuas pts), ntawm lawv, IRC-soj ntsuam ORR thiab DCR yog 35.6% (CR: 2/87 thiab PR: 29/87) thiab 88.5% feem; DoR tsis tau mus txog thiab tus nqi 9m-DoR yog 80.7%. Ntawm 98 pts, qhov nruab nrab (95% CI) PFS thiab OS yog 9.5m (5.6, -) thiab 21.3m (17.3, -) raws li. Raws li kev kho mob bevacizumab yav dhau los, ORR yog 40.9% vs 30.3%, thiab qhov nruab nrab (95% CI) PFS yog 13.8m (4.1, -) vs 9.5m (5.5, -).
Cov xwm txheej tsis zoo yog sib xws nrog cov uas tau tshaj tawm rau kev kho mob zoo sib xws thiab cov tshuaj antiangiogenic ua ke.
Txog Sintilimab
Sintilimab, muag raws li TYVYT (sintilimab txhaj tshuaj) hauv Suav teb, yog PD-1 immunoglobulin G4 monoclonal antibody uas tau tsim los ntawm Innovent thiab Eli Lilly thiab Company. Sintilimab yog ib hom immunoglobulin G4 monoclonal antibody, uas khi rau PD-1 molecules ntawm qhov chaw ntawm T-cells, thaiv txoj kev PD-1 / PD-Ligand 1 (PD-L1), thiab rov ua kom T-cells tua cov hlwb qog noj ntshav. Hauv Suav teb, sintilimab tau pom zoo thiab suav nrog hauv NRDL hloov kho tshiab rau xya qhov cim qhia. Qhov hloov kho tshiab NRDL them rov qab rau TYVYT (sintilimab txhaj tshuaj) suav nrog:
Rau kev kho mob ntawm cov kab mob Hodgkin uas rov qab mob dua lossis tsis kho tau tom qab ob kab lossis tom qab ntawm kev kho mob chemotherapy;
Rau kev kho mob thawj kab ntawm mob qog nqaij hlav hauv zos uas tsis tuaj yeem phais tau lossis kis mus rau lwm qhov uas tsis yog mob qog nqaij hlav me me uas tsis muaj kev hloov pauv ntawm EGFR lossis ALK;
Rau kev kho mob rau cov neeg mob uas muaj mob qog nqaij hlav hauv lub ntsws uas tsis yog squamous non-small cell lossis EGFR-mutated uas tau hloov pauv mus rau lwm qhov chaw uas tau nce qib tom qab kev kho mob EGFR-TKI;
Rau kev kho mob thawj kab ntawm mob qog nqaij hlav squamous non-small cell lung cancer uas tsis tuaj yeem phais tau hauv zos lossis metastatic;
Rau kev kho mob thawj kab ntawm cov mob qog nqaij hlav hepatocellular carcinoma uas tsis tuaj yeem phais lossis kis mus rau lwm qhov uas tsis muaj kev kho mob ua ntej;
Rau kev kho mob thawj kab ntawm cov mob qog nqaij hlav esophageal squamous cell carcinoma uas tsis tuaj yeem phais tau hauv zos, rov tshwm sim lossis kis mus rau lwm qhov;
Rau kev kho mob thawj kab ntawm cov qog nqaij hlav gastric lossis gastroesophageal junction adenocarcinoma uas tsis tuaj yeem phais tau hauv zos, rov tshwm sim lossis kis mus rau lwm qhov.
Ntxiv mus, sintilimab qhov cim qhia thib yim, ua ke nrog fruquintinib rau kev kho mob ntawm cov neeg mob uas muaj mob qog nqaij hlav endometrial nrog cov qog pMMR uas tau ua tsis tiav kev kho mob yav dhau los thiab tsis yog cov neeg sib tw rau kev phais mob lossis kev kho hluav taws xob, tau pom zoo los ntawm NMPA thaum Lub Kaum Ob Hlis 2024.
Ntxiv rau, ob txoj kev tshawb fawb txog sintilimab tau ua tiav lawv cov ntsiab lus tseem ceeb:
Kev tshawb fawb theem 2 ntawm sintilimab monotherapy ua kev kho mob thib ob ntawm esophageal squamous cell carcinoma;
Kev tshawb fawb theem 3 ntawm sintilimab monotherapy ua kev kho mob thib ob rau mob qog nqaij hlav squamous non-small cell nrog kev nce qib ntawm tus kab mob tom qab platinum-based chemotherapy.
Txog Fruquintinib
Fruquintinib yog ib qho tshuaj uas xaiv tau los ntawm kev noj uas tiv thaiv tag nrho peb yam vascular endothelial growth factor (“VEGF”) receptors (VEGFR-1, -2 thiab -3). VEGFR inhibitors ua lub luag haujlwm tseem ceeb hauv kev tiv thaiv qog angiogenesis. Fruquintinib tau tsim los kom muaj kev xaiv zoo dua uas txwv tsis pub muaj kev ua haujlwm ntawm cov kinase uas tsis yog lub hom phiaj, uas ua rau muaj kev siv tshuaj uas ua rau muaj kev txwv tsis pub muaj lub hom phiaj thiab yooj yim rau kev siv ua ib feem ntawm kev kho mob ua ke.
Fruquintinib tau txais kev pom zoo rau kev lag luam rau kev kho mob rau cov neeg mob uas muaj mob qog nqaij hlav colorectal metastatic uas tau txais fluoropyrimidine, oxaliplatin thiab irinotecan-based chemotherapy, thiab cov neeg uas tau txais lossis tsis tsim nyog rau kev txais kev kho mob anti-VEGF lossis anti-epidermal growth factor receptor ("EGFR") therapy (RAS wild-type) hauv Suav teb, qhov chaw uas nws tau tsim thiab ua lag luam los ntawm HUTCHMED thiab Eli Lilly thiab Company nyob rau hauv lub npe lag luam ELUNATE. Nws tau suav nrog hauv Daim Ntawv Teev Tshuaj Rov Qab Nyiaj Hauv Tebchaws Suav ("NRDL") thaum Lub Ib Hlis 2020. Txij li thaum nws tau tso tawm hauv Suav teb, ntau dua 100,000 tus neeg mob uas muaj mob qog nqaij hlav colorectal tau kho nrog fruquintinib.
Thaum Lub Kaum Ob Hlis Ntuj xyoo 2024, fruquintinib tau txais kev pom zoo los ntawm NMPA ua ke nrog sintilimab rau kev kho mob rau cov neeg mob uas muaj mob qog nqaij hlav endometrial siab heev nrog cov qog pMMR uas tau ua tsis tiav kev kho mob yav dhau los thiab tsis yog cov neeg sib tw rau kev phais kho lossis kev kho hluav taws xob.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
Email:myimmnet@163.com
Cov ntaub ntawv siv los ua piv txwv
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
Lub sijhawm tshaj tawm: Lub Kaum Ob Hlis-16-2024