Penpulimab Yalandira Chilolezo cha NMPA cha Chithandizo Choyamba cha Khansa ya M'mphuno

Pa 16 Marichi, 2025, Akeso adalengeza kuti mankhwala ake atsopano oletsa khansa ya PD-1 monoclonal, penpulimab, avomerezedwa mwalamulo ndi National Medical Products Administration (NMPA) kuti agwiritsidwe ntchito pochiza khansa ya m'mphuno yobwerezabwereza kapena yofalikira (NPC) pamodzi ndi chemotherapy.

Penpulimab (PD-1 Monoclonal Antibody） pakadali pano ndiye antibody yokhayo ya PD-1 monoclonal yomwe imagwiritsa ntchito mtundu wa IgG1 ndi Fc-nulldomain yosinthidwa, yomwe ingathandize kwambiri kuchiza matenda a chitetezo chamthupi ndikuchepetsa zotsatira zoyipa zokhudzana ndi chitetezo chamthupi. Imagwiritsidwa ntchito pochiza matenda akuluakulu monga khansa ya m'mapapo, lymphoma, khansa ya m'mphuno, khansa ya chiwindi, ndi khansa ya m'mimba, ndi chitetezo chokwanira komanso kugwira ntchito bwino monga momwe zasonyezedwera m'maphunziro azachipatala.

Ichi ndi chizindikiro chachinayi chovomerezeka cha penpulimab. Kuwonjezera pa zizindikiro ziwiri za NPC, penpulimab imavomerezedwanso kuti igwiritsidwe ntchito pochiza khansa ya m'mapapo ya squamous non-small cell (NSCLC) yomwe yakhala ikugwiritsidwa ntchito m'malo mwake ikaphatikizidwa ndi chemotherapy, komanso pochiza odwala omwe ali ndi matenda a Hodgkin lymphoma (cHL) omwe adachira kapena omwe adalandirapo mitundu iwiri ya chemotherapy. Kuphatikiza apo, New Drug Application (sNDA) yowonjezera ya penpulimab pamodzi ndi anlotinib pochiza khansa ya m'mapapo yapakhungu (HCC) ikuwunikidwanso pakadali pano.

Kale, penpulimab idavomerezedwa kuti igwiritsidwe ntchito ngati chithandizo cha mzere wachitatu cha NPC yapamwamba. Ndi chivomerezo chatsopanochi, penpulimab tsopano imapereka chithandizo chokwanira m'magawo onse a NPC, ndikupatsa odwala njira yopitilira yothandizira chitetezo chamthupi kuyambira mzere woyamba mpaka wachitatu.

Pa June 19, 2024, bungwe la “Signal Transduction and Targeted Therapy” linafalitsa zotsatira za kafukufuku wa gawo lachiwiri pa chithandizo cha khansa ya m'mphuno yomwe inayamba kufalikira ndi pembrolizumab.

Kuyesa kwa gawo lachiwiri kumeneku komwe kunachitika m'zipatala 20 zapamwamba ku China kunalembetsa odwala akuluakulu omwe ali ndi khansa ya m'mphuno (NPC) yomwe inafalikira m'mizere iwiri kapena kuposerapo ya mankhwala am'mbuyomu. Odwala adalandira penpulimab 200 mg kudzera m'mitsempha milungu iwiri iliyonse (masabata anayi pa nthawi iliyonse) mpaka matenda atakula kapena poizoni wosapiririka. Mapeto ake anali olondola poyankha (ORR) pa RECIST (mtundu 1.1), monga momwe komiti yodziyimira payokha yowunikira ma radiology inawunikira. Mapeto ake achiwiri anali opitilira popanda kupulumuka (PFS) ndi kupulumuka konse (OS). Odwala zana limodzi ndi makumi atatu adalembetsa ndipo 125 adayesedwa bwino. Pa tsiku lomaliza la deta (Seputembala 28, 2022), wodwala m'modzi adayankha mokwanira ndipo odwala 34 adayankha pang'ono. ORR inali 28.0% (95% CI 20.3–36.7%). Mayankho anali olimba, ndipo 66.8% adayankhabe ali ndi miyezi 9. Odwala makumi atatu ndi atatu (26.4%) anali akadali pa chithandizo. Avereji ya PFS ndi OS inali miyezi 3.6 (95% CI = miyezi 1.9–7.3) ndi miyezi 22.8 (95% CI = miyezi 17.1 kuti isafike), motsatana. Odwala khumi (7.6%) adakumana ndi irAEs ya giredi 3 kapena kupitirira apo. Penpulimab ili ndi ntchito zabwino zotsutsana ndi chotupa komanso poizoni wovomerezeka mwa odwala a NPC omwe adachiritsidwa kale, zomwe zimathandiza chitukuko china chachipatala ngati chithandizo chachitatu cha NPC yofalikira.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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