Kekemapa 04, 2024, ua hāʻawi ʻia ka New Drug Application (NDA) no ka hui pū ʻana o TYVYT® (sintilimab injection) a me ELUNATE® (fruquintinib) i ka ʻae ʻia ma Kina no ka mālama ʻana i nā maʻi me ka maʻi ʻaʻai endometrial holomua me nā puʻupuʻu Mismatch Repair proficient (pMMR) i hāʻule i ka lāʻau lapaʻau systemic ma mua a ʻaʻole ia he mau moho no ke ʻoki kino curative a i ʻole ka radiation. Ma hope o kēia ʻae ʻia ke kūlana loiloi koʻikoʻi a me ka hoʻolālā ʻana o ka breakthrough therapy e ka National Medical Products Administration (NMPA) o Kina a hōʻailona i ka hōʻailona ʻewalu i ʻae ʻia no TYVYT® (sintilimab injection).
Ua kākoʻo ʻia ka ʻae ʻia ʻana e ka NMPA e ka ʻikepili pae hoʻopaʻa inoa mai FRUSICA-1, ka hui hoʻopaʻa inoa maʻi ʻaʻai endometrial o kahi noiʻi Phase 2 multi-center, open-label e noiʻi ana i ka sintilimab i hui pū ʻia me fruquintinib i nā poʻe maʻi ʻaʻai endometrial i loaʻa i ka hoʻi hou ʻana o ka maʻi, ka holomua o ka maʻi a i ʻole ka ʻawaʻawa hiki ʻole ke hoʻomanawanui me ka mālama ʻana ma ka chemotherapy doublet i hoʻokumu ʻia i ka platinum. Ua hōʻike ʻia nā hopena mai FRUSICA-1 ma ka hālāwai makahiki o ka American Society of Clinical Oncology i Iune 2024.
AUa kākau inoa ʻia he 98 mau pts me ke kūlana pMMR a loaʻa i ka lāʻau lapaʻau hui pū ʻia. Ua loaʻa mua i nā pts āpau ma ka liʻiliʻi o ka lāʻau lapaʻau ʻōnaehana platinum laina mua, a ua loaʻa i ka 22.4% pts ka lāʻau lapaʻau bevacizumab. Ua hōʻuluʻulu ʻia nā moʻolelo maʻi kikoʻī ma ka papa. Me ka manawa hahai waena (95% CI) o 15.7m (14.6, 17.7), 87/98 pts i loaʻa ma ka liʻiliʻi hoʻokahi hopena loiloi tumor post-baseline (efficacy evaluable pts), i waena o lākou, ʻo IRC-assessed ORR a me DCR he 35.6% (CR: 2/87 a me PR: 29/87) a me 88.5% pakahi; ʻAʻole i hiki ʻia ʻo DoR a ʻo ka helu 9m-DoR he 80.7%. Ma waena o 98 pts, ʻo ka awelika (95% CI) PFS a me OS he 9.5m (5.6, -) a me 21.3m (17.3, -) pakahi. Ma muli o ka lāʻau lapaʻau bevacizumab ma mua, ʻo ORR he 40.9% vs 30.3%, a ʻo ka awelika (95%CI) PFS he 13.8m (4.1, -) vs 9.5m (5.5, -).
Ua kūlike nā hanana ʻino me nā mea i hōʻike ʻia no nā lāʻau lapaʻau like ʻole o ka immunotherapy a me nā mea antiangiogenic.
E pili ana iā Sintilimab
ʻO Sintilimab, i kūʻai ʻia aku ma ke ʻano he TYVYT (sintilimab injection) ma Kina, he PD-1 immunoglobulin G4 monoclonal antibody i hoʻomohala pū ʻia e Innovent lāua ʻo Eli Lilly and Company. ʻO Sintilimab kahi ʻano immunoglobulin G4 monoclonal antibody, kahi e hoʻopaʻa ai i nā molekala PD-1 ma luna o ka ʻili o nā T-cell, e ālai ana i ke ala PD-1 / PD-Ligand 1 (PD-L1), a hoʻāla hou i nā T-cell e pepehi i nā cell cancer. Ma Kina, ua ʻae ʻia ʻo sintilimab a ua hoʻokomo ʻia i loko o ka NRDL hou no ʻehiku mau hōʻailona. ʻO ka laulā uku hoʻihoʻi NRDL hou no TYVYT (sintilimab injection) e komo pū ana me:
No ka mālama ʻana i ka lymphoma Hodgkin maʻamau i hoʻihoʻi ʻia a paʻakikī paha ma hope o ʻelua mau laina a ma hope paha o ka chemotherapy systemic;
No ka lāʻau lapaʻau mua o ka maʻi kanesa māmā non-squamous non-small cell lung cancer hiki ʻole ke ʻoki ʻia ma kahi holomua a metastatic paha me ka nele i nā mutations gene driver EGFR a i ʻole ALK;
No ka mālama ʻana i nā poʻe maʻi me ka maʻi kanesa māmā non-smamous cell lung cancer i hoʻololi ʻia ma kahi o EGFR a i ʻole metastatic i holomua ma hope o ka lāʻau lapaʻau EGFR-TKI;
No ka mālama mua ʻana i ka maʻi kanesa māmā squamous non-small cell i hoʻomaka ʻole ʻia a i ʻole metastatic;
No ka lāʻau lapaʻau mua o ka carcinoma hepatocellular hiki ʻole ke ʻoki ʻia a metastatic paha me ka ʻole o ka lāʻau lapaʻau ʻōnaehana mua;
No ka mālama mua ʻana i ka carcinoma squamous cell esophageal holomua, recurrent a metastatic paha i hiki ʻole ke ʻoki ʻia;
No ka mālama mua ʻana i ka adenocarcinoma gastric a i ʻole gastroesophageal junction i hiki ʻole ke ʻoki ʻia ma kahi holomua, recurrent a metastatic paha.
Eia kekahi, ʻo ka hōʻailona ʻewalu o sintilimab, i hui pū ʻia me fruquintinib no ka mālama ʻana i nā maʻi me ka maʻi ʻaʻai endometrial holomua me nā ʻōpū pMMR i hāʻule ʻole i ka lāʻau lapaʻau systemic ma mua a ʻaʻole he mau moho no ke ʻoki ʻana i ka lāʻau lapaʻau a i ʻole ka radiation, ua ʻae ʻia e ka NMPA i Dekemaba 2024.
Eia kekahi, ua hālāwai ʻelua mau haʻawina lapaʻau o sintilimab i kā lākou mau hopena mua:
Haʻawina Pae 2 o ka sintilimab monotherapy ma ke ʻano he lāʻau lapaʻau lua o ka esophageal squamous cell carcinoma;
Ke aʻo ʻana i ka pae 3 o ka sintilimab monotherapy ma ke ʻano he lāʻau lapaʻau lua no ka maʻi kanesa māmā squamous non-small cell me ka holomua o ka maʻi ma hope o ka chemotherapy platinum-based.
E pili ana iā Fruquintinib
He mea hoʻopaʻa waha koho ʻo Fruquintinib o nā mea loaʻa ʻekolu o ka vascular endothelial growth factor ("VEGF") (VEGFR-1, -2 a me -3). He kuleana koʻikoʻi ko nā mea hoʻopaʻa VEGFR i ka pale ʻana i ka angiogenesis tumor. Ua hoʻolālā ʻia ʻo Fruquintinib e loaʻa ka selectivity i hoʻonui ʻia e kaupalena ana i ka hana kinase off-target, e ʻae ana i ka hōʻike ʻana i ka lāʻau lapaʻau e hoʻokō ai i ka pale mau ʻana o ka pahuhopu a me ka maʻalahi no ka hoʻohana hiki ke hoʻohana ʻia ma ke ʻano he ʻāpana o ka hui pū ʻana o ka lāʻau lapaʻau.
Ua ʻāpono ʻia ʻo Fruquintinib no ke kūʻai aku ʻana no ka mālama ʻana i nā poʻe maʻi me ka maʻi kanesa colorectal metastatic i loaʻa mua i ka chemotherapy fluoropyrimidine, oxaliplatin a me ka irinotecan, a me ka poʻe i loaʻa mua a ʻaʻole kūpono paha no ka loaʻa ʻana o ka lāʻau anti-VEGF a i ʻole ka lāʻau anti-epidermal growth factor receptor ("EGFR") (RAS wild-type) ma Kina, kahi i hoʻomohala pū ʻia ai a kūʻai pū ʻia e HUTCHMED lāua ʻo Eli Lilly and Company ma lalo o ka inoa inoa ʻo ELUNATE. Ua hoʻokomo ʻia i loko o ka China National Reimbursement Drug List ("NRDL") i Ianuali 2020. Mai kona hoʻomaka ʻana ma Kina, ua mālama ʻia ma mua o 100,000 mau poʻe maʻi me ka maʻi kanesa colorectal me fruquintinib.
I Dekemaba 2024, ua ʻāpono ʻia ʻo fruquintinib e NMPA i hui pū ʻia me sintilimab no ka mālama ʻana i nā maʻi me ka maʻi ʻaʻai endometrial holomua me nā ʻōpū pMMR i hāʻule ʻole i ka lāʻau lapaʻau systemic ma mua a ʻaʻole ia he mau moho no ke ʻoki kino curative a i ʻole ka radiation.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
Leka uila:myimmnet@163.com
Nā Kuhikuhi
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
Ka manawa hoʻouna: Dec-16-2024