Toripalimab-tpzi ta amince da FDA don ciwon daji na nasopharyngeal

A cikin Oktobar 2023, FDA ta amince da toripalimab-tpzi (LOQTORZ, Coherus BioSciences, Inc.) tare da cisplatin da gemcitabine a matsayin magani na farko ga mutanen da ke fama da ciwon daji na nasopharyngeal (NPC) wanda ya yada ko ya dawo. FDA ta amince da toripalimab-tpzi a matsayin magani guda ɗaya ga manya tare da NPC mai maimaitawa wanda ba a iya jurewa ba ko metastatic wanda ya ci gaba a lokacin ko bayan chemotherapy mai ɗauke da platinum.

An kimanta tasirin toripalimab-tpzi tare da cisplatin da gemcitabine a cikin JUPITER-02 (NCT03581786), bazuwar, yanki mai yawa, yanki guda ɗaya, makafi biyu, gwajin gwajin wuribo na marasa lafiya 289 tare da metastatic ko maimaitawa, NPC na gida waɗanda ba su da ci gaba. a baya an karɓi chemotherapy na tsarin don maimaita ko cutar metastatic. An ba da marasa lafiya bazuwar (1: 1) don karɓar toripalimab-tpzi tare da cisplatin da gemcitabine, sannan toripalimab-tpzi, ko placebo tare da cisplatin da gemcitabine, biye da placebo. Don cikakken bayani game da tsarin maganin chemotherapy, da fatan za a duba hanyar haɗin da ke sama.

Babban ma'aunin sakamako na tasiri shine tsira ba tare da ci gaba ba (PFS), kamar yadda Kwamitin Binciken Makafi mai zaman kansa ya ƙaddara (BIRC) ta amfani da RECIST v1.1. Gabaɗaya rayuwa (OS) wani sakamako ne. Haɗin toripalimab-tpzi ya nuna haɓakar ƙididdiga a cikin PFS, tare da matsakaicin PFS na watanni 11.7 tare da watanni 8.0 (rabin haɗari [HR] 0.52 [95% CI: 0.36, 0.74], p-darajar = 0.0003). An kuma ga ingantaccen ci gaba mai mahimmanci a cikin OS, tare da OS na tsakiya ba a samu ba (95% CI: watanni 38.7, ba ƙididdigewa ba) don tsarin toripalimab-tpzi mai ƙunshe da watanni 33.7 (95% CI: 27.0, 44.2) don placebo- dauke da tsari (HR 0.63 [95% CI: 0.45, 0.89], p=0.0083).

POLARIS-02 (NCT02915432) alama ce mai buɗewa, cibiyar sadarwa, ƙasa ɗaya, gwajin multicohort a cikin marasa lafiya 172 tare da marasa lafiya na 6 waɗanda ba za a iya gano su ba ko kuma sun sami ci gaban cutar sankara a cikin watanni 1.1 bayan kammala aikin chemotherapy na tushen platinum. a matsayin neoadjuvant, adjuvant, ko tabbataccen maganin chemoradiation don cututtukan da ke ci gaba a cikin gida. An bai wa marasa lafiya toripalimab-tpzi har sai cutar ta ci gaba ta hanyar RECIST vXNUMX ko rashin haƙuri mai guba.

An tabbatar da ma'aunin mahimmin mahimmin ma'auni na gaba ɗaya (ORR) da tsawon lokacin amsawa (DOR), kamar yadda BIRC ta ƙaddara ta amfani da RECIST v1.1. ORR ya kasance 21% (95% CI: 15, 28), tare da matsakaicin DOR na watanni 14.9 (95% CI: 10.3, ba ƙima ba).

Toripalimab-tpzi ya haifar da mummunan martani na rigakafi kamar su ciwon huhu, colitis, hepatitis, endocrinopathy, nephritis tare da gazawar koda, da halayen fata. Toripalimab-tpzi tare da cisplatin da gemcitabine sun haifar da halayen da ba su da kyau (≥20%), ciki har da tashin zuciya, amai, rage cin abinci, maƙarƙashiya, hypothyroidism, rash, pyrexia, gudawa, neuropathy na gefe, tari, ciwon musculoskeletal, kamuwa da cuta na numfashi na sama, rashin barci. , dizziness, da rashin jin daɗi. Rashin gajiya, hypothyroidism, da rashin jin daɗi na musculoskeletal sune mafi yawan tasirin da aka yi (≥20%) da aka ruwaito tare da toripalimab-tpzi a matsayin magani guda ɗaya.

Adadin da aka ba da shawarar na toripalimab-tpzi tare da cisplatin da gemcitabine shine 240 MG kowane mako uku har sai cutar ta ci gaba, rashin iya jurewa, ko har zuwa watanni 24. Adadin da aka ba da shawarar toripalimab-tpzi a matsayin jiyya ɗaya don maganin NPC da aka yi a baya shine 3 mg/kg kowane mako biyu har sai cutar ta ci gaba ko kuma rashin karɓuwa.

Duba cikakken bayanin rubutawa don LOQTORZI