Ua ʻāpono ʻia ʻo TEVIMBRA ma ʻAmelika Hui Pū ʻIa no ka Lapaʻau Laina Mua o ka Advanced Esophageal Squamous Cell Carcinoma i hui pū ʻia me Chemotherapy

Ma Malaki 4, 2025, ua hoʻolaha ʻo BeiGene ua ʻāpono ka US Food and Drug Administration (FDA) iā TEVIMBRA (tislelizumab-jsgr), i hui pū ʻia me ka chemotherapy i loaʻa ka platinum, no ka mālama mua ʻana i nā pākeke me ka unresectable a i ʻole metastatic esophageal squamous cell carcinoma (ESCC) nona nā tumors e hōʻike ana i ka PD-L1 (≥1).

Hoʻokumu ʻia ka hōʻailona hou aʻe ma nā hopena mai ka RATIONALE-306 a BeiGene (NCT03783442), he noiʻi Phase 3 randomized, placebo-controlled, double-blind, global e loiloi i ka pono a me ka palekana o TEVIMBRA i hui pū ʻia me ka chemotherapy platinum-loaʻa ma ke ʻano he lāʻau lapaʻau mua i nā poʻe maʻi makua (n=649) me ka ESCC recurrent a metastatic paha i hiki ʻole ke hoʻopau ʻia, locally advanced. Ua hālāwai ke aʻo ʻana me kāna hopena mua a hōʻike i kahi hoʻomaikaʻi koʻikoʻi i ka helu helu i ke ola holoʻokoʻa (OS) no nā poʻe maʻi makua i randomized i TEVIMBRA i hui pū ʻia me ka chemotherapy i hoʻohālikelike ʻia me ka placebo i hui pū ʻia me ka chemotherapy. Ua hōʻike nā loiloi ʻimi i ka hoʻomaikaʻi ʻana o ka heluna kanaka i manaʻo ʻia e mālama (ITT) i nā hopena i ʻike ʻia ma ka hui liʻiliʻi o nā poʻe maʻi me PD-L1 ≥1. Ua hōʻike ka loiloi o OS i loko o ka heluna kanaka PD-L1 maikaʻi (≥1) (n=481) i kahi OS waena o 16.8 mau mahina no nā maʻi i mālama ʻia me TEVIMBRA me ka chemotherapy i hoʻohālikelike ʻia me 9.6 mau mahina no nā maʻi i mālama ʻia me ka placebo me ka chemotherapy (HR: 0.66, [95% CI: 0.53, 0.82]), e hopena ana i ka emi ʻana o 34% i ka pilikia o ka make. Hōʻike kēia mau hopena i kahi hoʻomaikaʻi mua ʻole ʻia ma OS i nā maʻi ESCC laina mua.

E pili ana iā TEVIMBRA (tislelizumab-jsgr)®

He antibody monoclonal immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) i hoʻolālā kūikawā ʻia ʻo TEVIMBRA me ka affinity kiʻekiʻe a me ke kikoʻī paʻa e kūʻē i ka PD-1. Ua hoʻolālā ʻia e hōʻemi i ka nakinaki ʻana i nā mea loaʻa Fc-gamma (Fcγ) ma nā macrophages, e kōkua ana i nā ʻōnaehana pale o ke kino e ʻike a hakakā i nā ʻōpū.

E pili ana i ka Esophageal Squamous Cell Carcinoma (ESCC)

Ma ke ao holoʻokoʻa, ʻo ke kanesa esophageal ke ono o nā kumu maʻamau o nā make e pili ana i ke kanesa, a ʻo ESCC ka subtype histologic maʻamau, e helu ana no kahi kokoke i 90% o nā kanesa esophageal. Ua manaʻo ʻia he 957,000 mau hihia kanesa esophageal hou i ka makahiki 2040, he piʻi ʻana o kahi kokoke i 60% mai ka makahiki 2020, e hōʻike ana i ka pono no nā lāʻau lapaʻau hou aʻe.1 He maʻi make koke ke kanesa esophageal, a ʻoi aku ma mua o ʻelua hapakolu o nā maʻi i loaʻa i ka maʻi holomua a metastatic paha i ka manawa o ka ʻike ʻana, me ka manaʻo o ka helu ola ʻelima makahiki ma lalo o 6% no ka poʻe me nā metastases mamao.

Ua ʻāpono ʻia hoʻi ʻo TEVIMBRA ma ʻAmelika Hui Pū ʻIa ma ke ʻano he monotherapy no ka mālama ʻana i nā poʻe maʻi makua me ka unresectable a i ʻole metastatic esophageal squamous cell carcinoma ma hope o ka chemotherapy systemic mua i hoʻokomo ʻole ʻia i kahi PD-(L)1 inhibitor a me ka hui pū ʻana me ka chemotherapy no ka mālama mua ʻana i nā poʻe maʻi me ka gastric a me ka gastroesophageal junction (G/GEJ).

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

Email：myimmnet@163.com

Nā Kuhikuhi

1.国家药品监督管理局 (nmpa.gov.cn)

2.百济神州 |癌症没有国界。我们也没有。 (beigene.com)