Na Eprel 23, Penpulimab nke Akeso nwetara nkwenye site na Cisplatin ma ọ bụ carboplatin na gemcitabine maka ọgwụgwọ mbụ nke ndị toro eto nwere ọrịa kansa nasopharyngeal na-abụghị keratinizing (NPC) na-emegharị ugboro ugboro ma ọ bụ metastatic. FDA kwadokwara penpulimab-kcqx dị ka otu ọgwụ maka ndị toro eto nwere NPC na-abụghị keratinizing metastatic nke nwere ọganihu ọrịa na ma ọ bụ mgbe ọgwụ chemotherapy dabere na platinum dabere na ya na ma ọ dịkarịa ala otu usoro ọgwụgwọ ọzọ gara aga.
A tụlere irè nke penpulimab-kcqx na cisplatin ma ọ bụ carboplatin na gemcitabine na Study AK105-304 (NCT04974398), nnwale a na-eme n'ọtụtụ ebe n'ime mmadụ 291 nwere NPC ugboro ugboro ma ọ bụ nke na-anaghị enweta chemotherapy sistemụ mbụ maka ọrịa ugboro ugboro ma ọ bụ nke na-eme ka ahụ gbakee. A na-enye ndị ọrịa ọgwụ (1:1) iji nweta penpulimab-kcqx na cisplatin ma ọ bụ carboplatin na gemcitabine, wee nye penpulimab-kcqx, ma ọ bụ placebo na cisplatin ma ọ bụ carboplatin na gemcitabine, wee nye placebo. A kọwara usoro ọgwụgwọ kemotherapy na ozi zuru oke nke dọkịta nyere.
Ihe kacha pụta ìhè n'ihe gbasara arụmọrụ bụ ndụ na-enweghị ọganihu (PFS), dịka Kọmitii Nyocha Ndị Nọọrọ Onwe Ha Kwuru Nyochaa dịka RECIST v1.1 si kwuo. Ndụ zuru oke (OS) bụ isi ihe dị mkpa n'ọgwụgwụ nke abụọ. Ọkara PFS bụ ọnwa 9.6 (95% CI: 7.1, 12.5) n'aka penpulimab-kcqx na ọnwa 7.0 (95% CI: 6.9, 7.3) n'aka placebo (oke ihe egwu [HR] 0.45 [95% CI: 0.33, 0.62], uru p-akụkụ abụọ <0.0001), yana 31% na 11% nke ndị ọrịa dị ndụ ma ghara inwe ọganihu mgbe ọnwa 12 nke nleba anya na ogwe penpulimab-kcqx na placebo gasịrị, n'otu n'otu. Ọ bụ ezie na nsonaazụ OS ezughị oke, yana 70% nke ọnwụ e buru ụzọ kọwaa maka nyocha ikpeazụ akọpụtara, a hụghị ihe na-emerụ ahụ.
A nwalere irè nke otu ọgwụ penpulimab-kcqx na Study AK105-202 (NCT03866967), nnwale ogwe aka mepere emepe, nke nwere ọtụtụ etiti, nke e mere n'otu mba. Nnwale ahụ gụnyere ngụkọta nke ndị ọrịa 125 nwere NPC na-enweghị ike iwepụ ma ọ bụ nke na-abụghị keratinizing nke nwere ọganihu ọrịa mgbe ha mechara ọgwụgwọ ọgwụ platinum dabere na ya na opekata mpe otu usoro ọgwụgwọ ọzọ. Ndị ọrịa natara penpulimab-kcqx ruo mgbe ọrịa ahụ ga-aga n'ihu ma ọ bụ nsí a na-anaghị anabata, ruo ọnwa 24.
Ihe ndị bụ isi e ji chọpụta ihe kpatara ya bụ ọsọ nzaghachi (ORR) na oge nzaghachi (DOR) dịka RECIST v1.1 si kwuo dịka Kọmitii Nyocha Radiology Onwe Ya si kwuo. Na ụbọchị njedebe data (Septemba 28, 2022), otu onye ọrịa nwetara nzaghachi zuru oke na ndị ọrịa 34 nwetara nzaghachi akụkụ. ORR bụ 28.0% (95% CI 20.3–36.7%). Azịza ya siri ike, yana 66.8% ka nọ na nzaghachi na ọnwa 9. Ndị ọrịa 33 (26.4%) ka nọ na ọgwụgwọ. PFS na OS etiti bụ ọnwa 3.6 (95% CI = ọnwa 1.9–7.3) na ọnwa 22.8 (95% CI = ọnwa 17.1 ka e ruteghị), n'otu n'otu. Ndị ọrịa iri (7.6%) nwetara ọkwa 3 ma ọ bụ karịa irAEs. Penpulimab nwere ọrụ mgbochi etuto ahụ na nsí ndị a na-anabata nke ọma n'ime ndị ọrịa NPC nke a na-agwọbeghị nke ọma, na-akwado mmepe ahụike ọzọ dị ka ọgwụgwọ nke atọ nke NPC nke a na-agwọkarị.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
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Oge ozi: Eprel-25-2025