Ikigo gishinzwe ibiribwa n'imiti muri Amerika cyemeye kwamamaza penpulimab

Ku ya 23 Mata, penpulimab ya Akeso yemejwe n’Ikigo gishinzwe Ibiribwa n’Imiti hamwe na cisplatin cyangwa carboplatin na gemcitabine mu kuvura abantu bakuru bafite kanseri y’inkangu isubira cyangwa isubira inyuma. FDA kandi yemeje penpulimab-kcqx nk'umuti umwe ku bantu bakuru bafite NPC isubira inyuma kandi indwara ikomeza nyuma ya platine cyangwa nyuma ya platine ndetse nibura n'ubundi buryo bumwe bwo kuvura mbere.

Ingufu za penpulimab-kcqx hamwe na cisplatin cyangwa carboplatin na gemcitabine zasuzumwe mu Inyigo ya AK105-304 (NCT04974398), igerageza ryakozwe ku barwayi 291 barwaye NPC isubira cyangwa isubira inyuma batari barahawe imiti ya chimiotherapie isanzwe mbere y’indwara isubira inyuma cyangwa isubira inyuma. Abarwayi bakorewe ku buryo butaziguye (1:1) kugira ngo bahabwe penpulimab-kcqx hamwe na cisplatin cyangwa carboplatin na gemcitabine, hagakurikiraho penpulimab-kcqx, cyangwa placebo hamwe na cisplatin cyangwa carboplatin na gemcitabine, hagakurikiraho placebo. Imiti ya chimiotherapie isobanurwa mu makuru yuzuye yo gutanga imiti.

Igipimo cy'ibanze cy'umusaruro w'ingaruka nziza cyari ukurokoka kutagira iterambere (PFS), nk'uko byagenzuwe na Komite Ishinzwe Isuzuma ryigenga rya Blinded nk'uko bivugwa na RECIST v1.1. Kurokoka muri rusange (OS) byari ingenzi cyane. PFS yari amezi 9.6 (95% CI: 7.1, 12.5) mu kuboko kwa penpulimab-kcqx n'amezi 7.0 (95% CI: 6.9, 7.3) mu kuboko kwa placebo (igipimo cy'ibyago [HR] 0.45 [95% CI: 0.33, 0.62], agaciro ka p-impande ebyiri <0.0001), aho 31% na 11% by'abarwayi bariho kandi nta iterambere ryabo nyuma y'amezi 12 yo gukurikiranwa mu kuboko kwa penpulimab-kcqx na placebo, uko bikurikirana. Nubwo ibisubizo bya OS bitari bikiri bito, aho 70% by'impfu zavuzwe mbere ku isesengura rya nyuma byatangajwe, nta ngaruka mbi zagaragaye.

Ingufu za penpulimab-kcqx imwe zasuzumwe mu Inyigo ya AK105-202 (NCT03866967), igerageza ryakozwe mu gihugu kimwe, ryakozwe mu nzego nyinshi, rigizwe n'abarwayi 125 bafite NPC idakira cyangwa idatera keratiniza, barwaye nyuma yo guhabwa imiti ya chimiotherapie ishingiye kuri platine ndetse nibura n'ubundi buryo bumwe bwo kuvura. Abarwayi bahawe penpulimab-kcqx kugeza igihe indwara ikomeje cyangwa uburozi budakwiye, mu gihe kitarenze amezi 24.

Ibipimo by'ingenzi byakozwe mu gupima ingaruka z'ingaruka ni igipimo cy'ingaruka zifatika (ORR) n'igihe cy'ingaruka (DOR) nk'uko byagaragajwe na RECIST v1.1 nk'uko byagenzuwe na Komite Yigenga Ishinzwe Isuzuma rya Radiologie. Ku itariki ntarengwa yo gusuzuma amakuru (ku ya 28 Nzeri 2022), umurwayi 1 yasubije neza naho abarwayi 34 basubije igice. ORR yari 28.0% (95% CI 20.3–36.7%). Igisubizo cyari kirambye, aho 66.8% bagisubije mu mezi 9. Abarwayi 33 (26.4%) bari bakiri ku miti. Igipimo cya PFS na OS bari bafite amezi 3.6 (95% CI = amezi 1.9–7.3) n'amezi 22.8 (95% CI = amezi 17.1 kugeza ubu). Abarwayi icumi (7.6%) bagaragaje irAEs zo mu cyiciro cya 3 cyangwa hejuru. Penpulimab ifite ibikorwa byiza byo kurwanya ikibyimba n'uburozi bwemewe ku barwayi ba NPC bavuwe mbere y'uko bavurwa, ishyigikira iterambere ry'ubuvuzi nk'uburyo bwa gatatu bwo kuvura NPC ya metastatic.

Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.

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