Kua whakaaetia a TEVIMBRA i te US mō te Maimoatanga Tuatahi o te Mate Pukupuku Pūtau Squamous Essophageal Matatau i te taha o te Chemotherapy

I te 4 o Poutū-te-rangi, 2025, i panuitia e BeiGene kua whakaaetia e te US Food and Drug Administration (FDA) te TEVIMBRA (tislelizumab-jsgr), me te chemotherapy kei roto he platinum, hei maimoatanga tuatahi mō ngā pakeke he mate pukupuku squamous cell esophageal kāore e taea te tango, he mate pukupuku rānei kua horapa (ESCC) kei roto i ō rātou pukupuku te PD-L1 (≥1).

Ko te tohu tāpiri e ahu mai ana i ngā hua mai i te RATIONALE-306 a BeiGene (NCT03783442), he rangahau matapōkere, he whakahaere-placebo, he matapo-rua, ā-ao Wāhanga 3 hei aromatawai i te whai huatanga me te haumaru o TEVIMBRA me te chemotherapy kei roto he platinum hei maimoatanga raina tuatahi i roto i ngā tūroro pakeke (n=649) me te ESCC kāore e taea te tango, he ESCC kua horapa ā-rohe, he ESCC kua horapa rānei. I tutuki i te rangahau tōna pito tuatahi, ā, i whakaatu i te whakapainga nui o te tatauranga i roto i te oranga whānui (OS) mō ngā tūroro pakeke i whakaritea ki te TEVIMBRA me te chemotherapy ki te whakataurite ki te placebo me te chemotherapy. I whakaatuhia e ngā tātaritanga tūhura ko te whakapainga o te taupori hiahia-ki-te-maimoatanga (ITT) i ahu mai i ngā hua i kitea i roto i te rōpū iti o ngā tūroro me te PD-L1 ≥1. I whakaatuhia e te tātaritanga o te OS i roto i te taupori PD-L1 pai (≥1) (n=481) he OS toharite o te 16.8 marama mō ngā tūroro i rongoatia ki te TEVIMBRA me te chemotherapy, ki te whakaritea ki te 9.6 marama mō ngā tūroro i rongoatia ki te placebo me te chemotherapy (HR: 0.66, [95% CI: 0.53, 0.82]), ā, i hua ake he 34% te hekenga o te mōrearea o te mate. Ko ēnei hua he whakapainga kāore i kitea i mua i roto i te OS i roto i ngā tūroro ESCC raina tuatahi.

Mō TEVIMBRA (tislelizumab-jsgr)®

He paturopi monoclonal immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) a TEVIMBRA i hangaia motuhaketia, he kaha te hononga me te here motuhake ki te PD-1. Kua hangaia hei whakaiti i te here ki ngā kaiwhakawhiwhi Fc-gamma (Fcγ) i runga i ngā macrophage, hei āwhina i ngā pūtau ārai mate o te tinana ki te kite me te whawhai ki ngā pukupuku.

Mō te Mate Pukupuku Pūtau Squamous Essophageal (ESCC)

I te ao whānui, ko te mate pukupuku korokoro te tuaono o ngā tino take o ngā mate e pā ana ki te mate pukupuku, ā, ko te ESCC te momo histological tino noa, e tata ana ki te 90% o ngā mate pukupuku korokoro. E matapaetia ana he 957,000 ngā kēhi mate pukupuku korokoro hou e matapaetia ana i te tau 2040, he pikinga tata ki te 60% mai i te tau 2020, e whakaatu ana i te hiahia mō ētahi atu maimoatanga whai hua.1 He mate tere te mate pukupuku korokoro, ā, neke atu i te rua hautoru o ngā tūroro he mate kua horapa, kua horapa rānei i te wā e tātaritangahia ai, me te reiti oranga e rima tau te roa e tumanakohia ana he iti iho i te 6% mō te hunga kua horapa tawhiti.

Kua whakaaetia hoki a TEVIMBRA i te US hei rongoā kotahi mō ngā tūroro pakeke e pāngia ana e te mate pukupuku pūtau squamous esophageal kāore e taea te tango, kua horapa rānei i muri i te chemotherapy pūnaha o mua kāore i whakaurua he aukati PD-(L)1, ā, hei rongoā tahi me te chemotherapy mō te maimoatanga raina tuatahi o ngā pakeke e pāngia ana e te mate pukupuku puku me te gastroesophageal junction (G/GEJ).

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.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)