Musi wa23 Kubvumbi, mushonga weAkeso's penpulimab wakawana mvumo kubva kuFood and Drug Administration pamwe chete ne cisplatin kana carboplatin uye gemcitabine yekurapa vanhu vakuru vane chirwere chekenza chenasopharyngeal carcinoma (NPC) chinodzokororwa kana kuti chinopararira. FDA yakabvumidzawo penpulimab-kcqx semushonga mumwe chete kuvanhu vakuru vane chirwere chenasopharyngeal NPC chine chirwere chinoramba chichikura mushure me chemotherapy yeplatinum kana mushure me chemotherapy uye imwe nzira yekurapa yaimbovapo.
Kushanda kwepenpulimab-kcqx ne cisplatin kana carboplatin uye gemcitabine kwakaongororwa muChidzidzo cheAK105-304 (NCT04974398), bvunzo yerandomized, double-blind, multi-center muvarwere 291 vane recurrent kana metastatic NPC vasina kugamuchira systemic chemotherapy kare nekuda kwechirwere cherecurrent kana metastatic. Varwere vakaitwa randomized (1:1) kuti vagamuchire penpulimab-kcqx ne cisplatin kana carboplatin uye gemcitabine, ichiteverwa ne penpulimab-kcqx, kana placebo ne cisplatin kana carboplatin uye gemcitabine, ichiteverwa ne placebo. Chemotherapy regimens inotsanangurwa muruzivo rwakazara rwekunyorerwa.
Chiyero chikuru chekubudirira kwemhedzisiro yaive progression-free survival (PFS), sezvakaongororwa neBlinded Independent Review Committee zvichienderana neRECIST v1.1. Overall survival (OS) yaive secondary endpoint yakakosha. Median PFS yaive mwedzi 9.6 (95% CI: 7.1, 12.5) mu penpulimab-kcqx arm uye mwedzi 7.0 (95% CI: 6.9, 7.3) mu placebo arm (hazard ratio [HR] 0.45 [95% CI: 0.33, 0.62], two-sided p-value <0.0001), ne31% ne11% yevarwere vari vapenyu uye vasina progression mushure memwedzi gumi nemiviri yekutevera mu penpulimab-kcqx ne placebo arms, zvichiteerana. Kunyange hazvo mhedzisiro yeOS yakanga isati yakwana, ne70% yevakafa vakatarwa kare vekupedzisira ongororo yakashuma, hapana maitiro akaipa akaonekwa.
Kushanda kwemushonga we penpulimab-kcqx mumwe chete kwakaongororwa muChidzidzo cheAK105-202 (NCT03866967), bvunzo yeruoko rumwe chete, yakavhurika, yakaitwa munzvimbo dzakasiyana-siyana, yakaitwa munyika imwe chete. Kuongororwa uku kwakabatanidza varwere vanosvika zana nemakumi maviri nevashanu vane NPC isingabvisike kana kuti yakapararira mumuviri isina keratinizing avo vakaenderera mberi nechirwere mushure mekurapwa ne platinum-based chemotherapy uye imwe nzira yekurapa. Varwere vakagamuchira penpulimab-kcqx kusvika chirwere chaenderera mberi kana chepfu isingagamuchirwi, kwemwedzi inosvika makumi maviri nemana.
Zviyero zvikuru zvekubudirira kwemhedzisiro zvaive chiyero chekupindura chakanangana (ORR) uye nguva yekupindura (DOR) zvichienderana neRECIST v1.1 sezvakaongororwa neIndependent Radiology Review Committee. Pazuva rekupedzisira redata (Gunyana 28, 2022), murwere mumwe chete akagamuchira mhinduro yakazara uye varwere makumi matatu nevana vakawana mhinduro isina kukwana. ORR yaive 28.0% (95% CI 20.3–36.7%). Mhinduro yacho yaive yakasimba, ne66.8% vachiri kupindura pamwedzi mipfumbamwe. Varwere makumi matatu nevatatu (26.4%) vaive vachiri kurapwa. Avhareji yePFS neOS vaive nemwedzi 3.6 (95% CI = mwedzi 1.9–7.3) uye mwedzi 22.8 (95% CI = mwedzi 17.1 kusvika yasvika), zvichiteerana. Varwere gumi (7.6%) vakasangana ne irAEs dzegiredhi rechitatu kana kupfuura. Penpulimab ine mabasa anovimbisa ekudzivirira bundu uye chepfu inogamuchirwa muvarwere veNPC vakanyanya kurapwa vasati vatora mishonga, zvichitsigira kukura kwekiriniki senzira yechitatu yekurapa NPC yakapararira.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
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Nguva yekutumira: Kubvumbi-25-2025