I te 4 o Tīhema 2024, kua whakaaetia te Tono Rongoā Hou (NDA) mō te whakakotahitanga o te TYVYT® (werohanga sintilimab) me te ELUNATE® (fruquintinib) i Haina mō te maimoatanga o ngā tūroro he mate pukupuku endometrial matatau me ngā pukupuku Mismatch Repair proficient (pMMR) kua rahua te maimoatanga pūnaha o mua, ā, kāore e taea te whakamahi i te pokanga whakaora, i te irahiko rānei. E whai ana tēnei whakaaetanga i te mana arotake matua me te tohu whakaora hou e te National Medical Products Administration (NMPA) o Haina, ā, ko te waru o ngā tohu kua whakaaetia mō te TYVYT® (werohanga sintilimab).
I tautokona te whakaaetanga ā-ture e te NMPA e ngā raraunga wāhanga rēhita mai i FRUSICA-1, te rōpū rēhita mate pukupuku endometrial o tētahi rangahau Wāhanga 2 maha-pokapū, tuwhera-tohu e tirotiro ana i te sintilimab me te fruquintinib i roto i ngā tūroro mate pukupuku endometrial kua pāngia e te hokinga mai o te mate, te haere whakamua o te mate, te paitini kore e taea te manawanui me te maimoatanga i runga i te chemotherapy takirua e hangai ana ki te platinum. I tukuna ngā hua mai i FRUSICA-1 ki te hui ā-tau a te American Society of Clinical Oncology i te Pipiri 2024.
HeE 98 ngā tohu katoa me te mana pMMR i whakaurua, ā, i whiwhi i te maimoatanga whakakotahi. Kua whiwhi ngā tohu katoa i te iti rawa i te rongoā pūnaha kei roto i te platinum raina tuatahi, ā, e 22.4% ngā tohu kua whiwhi i te rongoā bevacizumab. Kua whakarāpopototia ngā hītori mate taipitopito ki te ripanga. Me te wā aroturuki waenga (95% CI) o te 15.7m (14.6, 17.7), 87/98 ngā tohu i te iti rawa i te kotahi te hua aromatawai pukupuku i muri i te tīmatanga (ngā tohu aromatawai whai hua), i roto i ēnei, ko te ORR me te DCR i aromatawaihia e te IRC he 35.6% (CR: 2/87 me te PR: 29/87) me te 88.5% ia; kāore i eke te DoR, ā, ko te reiti 9m-DoR he 80.7%. I roto i ngā tohu 98, ko te toharite (95% CI) o te PFS me te OS he 9.5m (5.6, -) me te 21.3m (17.3, -) ia. I runga i te rongoā bevacizumab o mua, ko te ORR he 40.9% vs 30.3%, ā, ko te toharite (95%CI) o te PFS he 13.8m (4.1, -) vs 9.5m (5.5, -).
He rite tonu ngā pānga kino ki ngā mea i pūrongohia mō ngā maimoatanga whakakotahitanga o te immunotherapy me ngā kaihoko antiangiogenic.
Mō Sintilimab
Ko te Sintilimab, e hokohokohia ana ko TYVYT (werohanga sintilimab) i Haina, he paturopi monoclonal PD-1 immunoglobulin G4 i whakawhanakehia tahitia e Innovent me Eli Lilly and Company. Ko te Sintilimab he momo paturopi monoclonal immunoglobulin G4, e herea ana ki ngā ngota PD-1 i runga i te mata o ngā pūtau-T, e aukati ana i te ara PD-1 / PD-Ligand 1 (PD-L1), ā, e whakahohe ana i ngā pūtau-T ki te patu i ngā pūtau matepukupuku. I Haina, kua whakaaetia te sintilimab, ā, kua whakaurua ki te NRDL whakahoutia mō ngā tohu e whitu. Ko te whānuitanga utu NRDL whakahoutia mō te TYVYT (werohanga sintilimab) kei roto:
Hei rongoā i te mate pukupuku Hodgkin tawhito kua hoki mai, kua uaua rānei te rongoā i muri i ngā momo rongoā chemotherapy pūnaha e rua, neke atu rānei;
Mō te maimoatanga tuatahi mō te mate pukupuku pūkahukahu kore-pūtau iti kāore e taea te tango, ā-rohe kua horapa, kāore rānei he whakarerekētanga ira EGFR, ALK rānei;
Hei rongoā i ngā tūroro he mate pukupuku pūkahukahu kore-pūtau iti kua whakarerekētia ki te EGFR ā-rohe, he mate pukupuku pūkahukahu kore-pūtau iti kua horapa ki te tinana, ā, kua whanake haere i muri i te rongoā EGFR-TKI;
Mō te maimoatanga tuatahi mō te mate pukupuku pūkahukahu kore-pūtau iti kāore e taea te tango, ā-rohe kua horapa, kua horapa rānei;
Mō te maimoatanga tuatahi o te mate pukupuku hepatocellular kāore e taea te tango, te mate pukupuku rānei kua horapa, kāore he maimoatanga pūnaha i mua;
Mō te maimoatanga tuatahi o te mate pukupuku pūtau squamous esophageal kua horapa ā-rohe, kua hokihoki mai, kua horapa rānei;
Mō te maimoatanga rārangi tuatahi o te adenocarcinoma o te puku, o te gastroesophageal junction rānei kua horapa ā-rohe, kāore e taea te tango, kua horapa rānei.
I tua atu, i whakaaetia e te NMPA i te Hakihea 2024 te tohu tuawaru o te sintilimab, me te fruquintinib mō te maimoatanga o ngā tūroro he mate pukupuku endometrial kua whanake haere me ngā pukupuku pMMR kua rahua te maimoatanga pūnaha o mua, ā, kāore e taea te whakamahi i te pokanga whakaora, i te irahiko rānei.
Hei tāpiritanga, e rua ngā rangahau haumanu mō te sintilimab kua tutuki i ā rāua whāinga matua:
Te rangahau Wāhanga 2 o te sintilimab monotherapy hei maimoatanga raina tuarua mō te mate pukupuku pūtau squamous esophageal;
He rangahau wāhanga 3 mō te sintilimab monotherapy hei maimoatanga tuarua mō te mate pukupuku pūkahukahu kore-pūtau iti me te haere whakamua o te mate whai muri i te chemotherapy e hangai ana ki te platinum.
Mō Fruquintinib
He aukati ā-waha whiriwhiri a Fruquintinib mō ngā kaiwhakawhiwhi tipu endothelial vascular (“VEGF”) e toru (VEGFR-1, -2 me -3). He mahi nui tā ngā aukati VEGFR ki te aukati i te angiogenesis pukupuku. I hangaia a Fruquintinib kia nui ake te whiriwhiringa e whakawhāiti ana i te mahi kinase i waho o te ūnga, e āhei ai te whakaaturanga rongoā e tutuki ai te aukati ūnga pumau me te ngāwari mō te whakamahinga pea hei wāhanga o te rongoā whakakotahi.
Kua whakaaetia a Fruquintinib mō te hokohoko hei rongoā mō ngā tūroro e pāngia ana e te mate pukupuku koroni kua horapa ki te toto, kua whiwhi kē i te rongoā chemotherapy e hangai ana ki te fluoropyrimidine, oxaliplatin me te irinotecan, me te hunga kua whiwhi kē, kāore rānei i te tika mō te rongoā anti-VEGF, te rongoā anti-epidermal growth factor receptor (“EGFR”) (RAS wild-type) rānei i Haina, i reira i whakawhanakehia ngātahitia ai, i hokohoko ngātahitia ai hoki e HUTCHMED me Eli Lilly and Company i raro i te ingoa waitohu ELUNATE. I whakaurua ki roto i te Rārangi Rongoā Whakahoki Moni ā-Motu o Haina (“NRDL”) i te marama o Hānuere 2020. Mai i tōna whakarewatanga i Haina, neke atu i te 100,000 ngā tūroro e pāngia ana e te mate pukupuku koroni kua rongoātia ki te fruquintinib.
I te Hakihea 2024, i whakaaetia te fruquintinib e te NMPA me te sintilimab hei rongoā mō ngā tūroro he mate pukupuku endometrial kua pāngia e ngā pukupuku pMMR kua rahua i te rongoā pūnaha o mua, ā, kāore e taea te whakamahi i te pokanga whakaora, i te irahiko rānei.
I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.
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Ngā Tohutoro
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
Wā tuku: Hakihea-16-2024