I-Toripalimab-tpzi igunyazwe yi-FDA ye-nasopharyngeal carcinoma

Ngo-Okthobar 2023, i-FDA igunyaze i-toripalimab-tpzi (LOQTORZ, Coherus BioSciences, Inc.) nge-cisplatin ne-gemcitabine njengokwelashwa komugqa wokuqala kubantu abanomdlavuza we-nasopharyngeal othuthukisiwe (i-NPC) osabalele noma obuyayo. I-FDA igunyaze i-toripalimab-tpzi njengokwelashwa okukodwa kwabantu abadala abane-NPC engalungiseki noma ye-metastatic eqhubeke phakathi noma ngemva kwe-chemotherapy equkethe i-platinum.

Ukusebenza kwe-toripalimab-tpzi ene-cisplatin ne-gemcitabine kuhlolwe ku-JUPITER-02 (NCT03581786), isifunda esingahleliwe, esimaphakathi, esisodwa, esingaboni kabili, isilingo esilawulwa yi-placebo seziguli ezingama-289 ezine-metastatic noma eziphindaphindayo, i-NPC ethuthukisiwe yasendaweni eyayingazange ngaphambili ithole i-systemic chemotherapy yesifo esiphindaphindayo noma se-metastatic. Iziguli zabelwa ngokungahleliwe (1:1) ukuze zithole i-toripalimab-tpzi ene-cisplatin ne-gemcitabine, ilandelwe yi-toripalimab-tpzi, noma i-placebo ene-cisplatin ne-gemcitabine, ilandelwe yi-placebo. Ukuze uthole ulwazi oluphelele lokuchaza ngemithi yokwelapha ngamakhemikhali, sicela ubheke isixhumanisi esingenhla.

Isilinganiso esibalulekile somphumela wokuphumelela kwaba ukusinda-mahhala (i-PFS), njengoba kunqunywe iKomidi Lokubuyekeza Elizimele Elingabonisiwe (BIRC) lisebenzisa i-RECIST v1.1. Ukusinda sekukonke (OS) bekungomunye umphumela. Inhlanganisela ye-toripalimab-tpzi ibonise ukuthuthuka okuphawulekayo kwezibalo ku-PFS, nge-PFS emaphakathi yezinyanga eziyi-11.7 iqhathaniswa nezinyanga eziyi-8.0 (isilinganiso sengozi [HR] 0.52 [95% CI: 0.36, 0.74], p-value=0.0003). Ukuthuthukiswa okuphawulekayo kwezibalo ku-OS kuphinde kwabonwa, nge-median OS engafinyelelwanga (95% CI: izinyanga ezingu-38.7, akucabangeki) ngohlelo oluqukethe i-toripalimab-tpzi kanye nezinyanga ezingu-33.7 (95% CI: 27.0, 44.2) ye-placebo- equkethe uhlobo lwemithi (HR 0.63 [95% CI: 0.45, 0.89], p=0.0083).

I-POLARIS-02 (NCT02915432) bekuyisivivinyo selebula elivulekile, elimaphakathi, ezweni elilodwa, ezigulini eziyi-172 ezine-NPC engenakuvinjwa noma ene-metastatic eyake yathola ukwelashwa ngamakhemikhali okusekelwe ku-platinum ngaphambili noma yaba nokuqhubekela phambili kwesifo phakathi nezinyanga ezingu-6 kuqedwe ukwelashwa ngamakhemikhali okusekelwe ku-platinum. njengokwelashwa kwe-neoadjuvant, i-adjuvant, noma i-chemoradiation eqondile yesifo esithuthuke endaweni. Iziguli zanikezwa i-toripalimab-tpzi kuze kube yilapho isifo siqhubeka nge-RECIST v1.1 noma ubuthi obungabekezeleleki.

Izinyathelo ezibalulekile zemiphumela yokusebenza ngempumelelo ziye zaqinisekiswa izinga lokuphendula eliphelele (ORR) kanye nobude besikhathi sokuphendula (DOR), njengoba kunqunywa i-BIRC isebenzisa i-RECIST v1.1. I-ORR yayingu-21% (95% CI: 15, 28), ene-DOR emaphakathi yezinyanga ezingu-14.9 (95% CI: 10.3, engalinganiselwe).

I-Toripalimab-tpzi iholele ekuphenduleni okungalungile kwe-immune-mediated njenge-pneumonitis, i-colitis, i-hepatitis, i-endocrinopathies, i-nephritis enokuhluleka kwezinso, kanye nokusabela kwesikhumba. I-Toripalimab-tpzi ene-cisplatin ne-gemcitabine ibangele ukusabela okubi okuvame kakhulu (≥20%), okuhlanganisa isicanucanu, ukuhlanza, ukuncipha kwesifiso sokudla, ukuqunjelwa, i-hypothyroidism, ukuqubuka, i-pyrexia, isifo sohudo, i-peripheral neuropathy, ukukhwehlela, ubuhlungu be-musculoskeletal, i-insomnia ukutheleleka kokuphefumula, , isiyezi, nokungalungi. Ukukhathala, i-hypothyroidism, kanye nokungakhululeki kwe-musculoskeletal kwakuyimiphumela emibi kakhulu (≥20%) ebikwe nge-toripalimab-tpzi njengesidakamizwa esisodwa.

Umthamo onconyiwe we-toripalimab-tpzi ene-cisplatin ne-gemcitabine ngu-240 mg njalo emavikini amathathu kuze kube yilapho isifo siqhubeka, ubuthi obungabekezeleleki, noma kufika ezinyangeni ezingu-24. Umthamo onconyiwe we-toripalimab-tpzi njengokwelashwa okukodwa kwe-NPC eyalashwe ngaphambilini ngu-3 mg/kg njalo emavikini amabili kuze kuqhubeke isifo noma ubuthi obungamukeleki.

Buka imininingwane egcwele ye-LOQTORZI