Toripalimab-tpzi waxa u ansixisay FDA ee kansarka sanbabada

Oktoobarr 2023, FDA waxay ogolaatay toripalimab-tpzi (LOQTORZ, Coherus BioSciences, Inc.) oo leh cisplatin iyo gemcitabine oo ah daawaynta safka koowaad ee dadka qaba kansarka sanbabada ee naasopharyngeal (NPC) oo faafay ama soo noqday. FDA waxay ansixisay toripalimab-tpzi inay tahay hal daawaynta loogu talagalay dadka qaangaarka ah ee leh NPC-da aan la soo celin karin oo soo noqnoqota ama metastatic NPC oo horumartay intii lagu jiray ama ka dib kiimiko-ku-darka platinum.

Waxtarka toripalimab-tpzi oo leh cisplatin iyo gemcitabine ayaa lagu qiimeeyay JUPITER-02 (NCT03581786), oo aan kala sooc lahayn, xarun badan, hal gobol, laba-indho la'aan, tijaabada placebo-control ee bukaannada 289 ee qaba metastatic ama soo noqnoqda, NPC gudaha ah Horey ayaa loo helay kiimoterabi nidaamsan oo loogu talagalay cudurrada soo noqnoqda ama metastatic. Bukaannada ayaa si aan kala sooc lahayn loo qoondeeyay (1: 1) si ay u helaan toripalimab-tpzi oo leh cisplatin iyo gemcitabine, oo ay ku xigto toripalimab-tpzi, ama placebo oo leh cisplatin iyo gemcitabine, oo ay ku xigto placebo. Si aad u hesho macluumaad dhammaystiran oo ku saabsan hababka daaweynta kemotherabi, fadlan eeg xidhiidhka sare.

Qiyaasta natiijada waxtarka ee muhiimka ah waxay ahayd badbaadada-horumar-la'aanta (PFS), sida ay go'aamiyeen Guddiga Dib-u-eegista Madax-bannaan ee Indho-la'aanta ah (BIRC) iyagoo isticmaalaya RECIST v1.1. Guud ahaan badbaadada (OS) waxay ahayd natiijo kale. Isku-dhafka toripalimab-tpzi wuxuu muujiyay horumar la taaban karo oo ku yimid PFS, oo leh dhexdhexaad PFS ee bilaha 11.7 iyo bilaha 8.0 (saamiga khatarta [HR] 0.52 [95% CI: 0.36, 0.74], p-value = 0.0003). Horumarka la taaban karo ee OS ayaa sidoo kale la arkay, iyadoo dhexdhexaadinta OS aan la gaarin (95% CI: 38.7 bilood, aan la qiyaasi karin) ee nidaamka toripalimab-tpzi-ku jira iyo bilaha 33.7 (95% CI: 27.0, 44.2) ee placebo- nidaam ka kooban (HR 0.63 [95% CI: 0.45, 0.89], p=0.0083).

POLARIS-02 (NCT02915432) waxay ahayd calaamad furan, xarun badan, hal waddan, tijaabo kooxeedyo badan oo bukaanno 172 ah oo qaba NPC aan la sixin karin ama metastatic kuwaas oo helay kiimiko ku salaysan platinum-ka hore ama lahaa horumarinta cudurka 6 bilood gudahood marka la dhammeeyo daaweynta kemotherabi ku salaysan platinum. sida neoadjuvant, adjuvant, ama daawaynta chemoradiation qeexan ee cudurada deegaanka horumaray. Bukaannada waxaa la siiyay toripalimab-tpzi ilaa uu cudurku ka sii socdo RECIST v1.1 ama sunta aan loo dulqaadan karin.

Tallaabooyinka waxtarka leh ee muhiimka ah ayaa la xaqiijiyay heerka jawaabta guud (ORR) iyo muddada jawaabta (DOR), sida ay go'aamisay BIRC iyadoo la adeegsanayo RECIST v1.1. ORR wuxuu ahaa 21% (95% CI: 15, 28), oo leh dhexdhexaad DOR ah bilaha 14.9 (95% CI: 10.3, lama qiyaasi karo).

Toripalimab-tpzi waxay keentay jawaab celin liddi ku ah difaaca jirka sida pneumonitis, colitis, cagaarshow, endocrinopathy, nephritis oo leh kelyaha oo shaqeynayo, iyo falcelinta maqaarka. Toripalimab-tpzi oo leh cisplatin iyo gemcitabine ayaa sababay falcelinta xun ee ugu badan (≥20%), oo ay ku jiraan lallabbo, matag, rabitaanka cuntada oo yaraada, calool-istaagga, hypothyroidism, finan, pyrexia, shuban, neuropathy peripheral, qufac, muruq xanuun, caabuqa neef-mareenka, hurdo la'aan. dawakhaad, iyo xanuun. Daal, hypothyroidism, iyo raaxo la'aanta murqaha ayaa ah saameynta xun ee ugu badan (≥20%) lagu sheegay toripalimab-tpzi sida hal daawo.

Qiyaasta lagu taliyey ee toripalimab-tpzi oo leh cisplatin iyo gemcitabine waa 240 mg saddexdii toddobaadba mar ilaa uu cudurku ka sii socdo, suntan aan loo dulqaadan karin, ama ilaa 24 bilood. Qiyaasta lagu taliyey ee toripalimab-tpzi sida hal daawaynta hore loogu daaweeyay NPC waa 3 mg/kg labadii toddobaadba mar ilaa cudurku ka sii socdo ama sunta aan la aqbali karin.

Eeg macluumaadka qoritaanka oo buuxa LOQTORZI