A ranar 23 ga Afrilu, Penpulimab na Akeso ya sami amincewar Hukumar Abinci da Magunguna da cisplatin ko carboplatin da gemcitabine don maganin farko ga manya da ke fama da cutar kansa ta nasopharyngeal wadda ba ta sake faruwa ba ko kuma ta sake faruwa (NPC). Hukumar FDA ta kuma amince da penpulimab-kcqx a matsayin magani guda ɗaya ga manya da ke fama da cutar kansa ta nasopharyngeal wadda ba ta sake faruwa ba, wadda ke da ci gaban cututtuka a kan ko bayan maganin chemotherapy na platinum da kuma aƙalla wani magani na baya.
An kimanta ingancin penpulimab-kcqx tare da cisplatin ko carboplatin da gemcitabine a cikin Nazarin AK105-304 (NCT04974398), wani gwaji na bazuwar, makafi biyu, mai cibiyoyi da yawa a cikin marasa lafiya 291 da ke fama da NPC mai maimaitawa ko mai tasowa waɗanda ba su taɓa shan maganin chemotherapy na tsarin ba a baya don cututtukan da suka sake dawowa ko masu tasowa. An ba marasa lafiya damar karɓar ko dai penpulimab-kcqx tare da cisplatin ko carboplatin da gemcitabine, sannan sai penpulimab-kcqx, ko placebo tare da cisplatin ko carboplatin da gemcitabine, sannan sai placebo. An bayyana tsarin chemotherapy a cikin cikakken bayanin da aka rubuta.
Babban ma'aunin sakamako mai inganci shine rayuwa ba tare da ci gaba ba (PFS), kamar yadda Kwamitin Bita Mai Zaman Kanta Mai Rufe Ido ya kimanta bisa ga RECIST v1.1. Jimlar rayuwa (OS) babban ma'auni ne na biyu. Matsakaicin PFS shine watanni 9.6 (95% CI: 7.1, 12.5) a cikin hannun penpulimab-kcqx da watanni 7.0 (95% CI: 6.9, 7.3) a cikin hannun placebo (rabowar haɗari [HR] 0.45 [95% CI: 0.33, 0.62], ƙimar p mai gefe biyu <0.0001), tare da 31% da 11% na marasa lafiya da ke raye kuma ba su da ci gaba bayan watanni 12 na bin diddigin a cikin hannun penpulimab-kcqx da placebo, bi da bi. Duk da cewa sakamakon OS bai balaga ba, tare da kashi 70% na mutuwar da aka riga aka ƙayyade don binciken ƙarshe, ba a lura da wani mummunan yanayi ba.
An kimanta ingancin maganin penpulimab-kcqx a cikin Nazarin AK105-202 (NCT03866967), wani gwaji mai lakabin budewa, mai cibiya da yawa, da hannu ɗaya da aka gudanar a ƙasa ɗaya. Gwajin ya haɗa da jimillar marasa lafiya 125 da ke ɗauke da NPC mara keratinizing wanda ba za a iya cirewa ba ko kuma wanda ya kamu da cutar bayan maganin chemotherapy na tushen platinum da aƙalla wani magani guda ɗaya. Marasa lafiya sun karɓi maganin penpulimab-kcqx har sai cutar ta ci gaba ko kuma guba da ba za a iya yarda da ita ba, na tsawon watanni 24.
Manyan matakan sakamako masu inganci sune ƙimar amsawar da aka yi da gangan (ORR) da tsawon lokacin amsawar (DOR) bisa ga RECIST v1.1 kamar yadda Kwamitin Bita na Radiology Mai Zaman Kansa ya kimanta. A ranar yanke bayanai (Satumba 28, 2022), majiyyaci 1 ya sami cikakken amsawa kuma marasa lafiya 34 sun sami cikakken amsawa. ORR ya kasance 28.0% (95% CI 20.3–36.7%). Amsar ta daɗe, tare da 66.8% har yanzu suna cikin amsawa a watanni 9. Marasa lafiya talatin da uku (26.4%) har yanzu suna kan magani. Matsakaicin PFS da OS sun kasance watanni 3.6 (95% CI = watanni 1.9–7.3) da watanni 22.8 (95% CI = watanni 17.1 ba a kai su ba), bi da bi. Marasa lafiya goma (7.6%) sun sami ajin 3 ko sama da haka irAEs. Penpulimab yana da ayyukan hana ƙari da kuma guba mai kyau ga marasa lafiya da suka kamu da cutar NPC da suka kamu da cutar kafin a yi musu magani, wanda ke taimakawa wajen ci gaba da samun ci gaba a asibiti a matsayin magani na uku na cutar NPC da ta kamu da cutar.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Lokacin Saƙo: Afrilu-25-2025