FDA inodzokorora chiratidzo chepembrolizumab chegomarara remudumbu

Chikafu neDrug Administration yakagadziridza kushandiswa kwakabvumidzwa kwepembrolizumab (Keytruda, Merck) pamwe chete netrastuzumab, fluoropyrimidine, uye platinum-ine chemotherapy yekurapa HER2-positive gastric kana gastroesophageal junction adenocarcinoma iyo iri munharaunda yepamusoro, isingagadziriswi muvarwere, kana metastatic. vasati vawana kurapwa. Mvumo yakadzokororwa inodzikamisa kushandiswa kwechiratidzo ichi kune varwere vane mapundu anoratidza PD-L1 (CPS ≥ 1) sezvaonekwa neFDA-yakatenderwa bvunzo, vachiri kutevedzera yakakurumidza kubvumidzwa mirau.

Iyo FDA yakabvumidza iyo Agilent PD-L1 IHC 22C3 pharmDx sechishandiso chekuongorora chekuziva varwere vane gastric kana GEJ adenocarcinoma vane mapundu ane PD-L1 kutaura (CPS ≥ 1).

Kubudirira kwakaongororwa muKEYNOTE-811 (NCT03615326), chidzidzo chakaitwa munzvimbo dzakawanda, apo varwere vane HER2-positive munharaunda yepamusoro kana metastatic gastric kana GEJ. adenocarcinoma avo vakanga vasati vaita chirongwa chekurapa kwechirwere chemetastatic vakagoverwa kuti vagamuchire kurapwa kana kuti placebo nenzira mbiri-mapofu. Varwere vakagoverwa kuti vagamuchire pembrolizumab 200 mg intravenously kana placebo masvondo ose e2 pamwe chete netrastuzumab uye fluorouracil pamwe necisplatin kana capecitabine pamwe neoxaliplatin muchiyero che1: 1.

Iwo ekutanga ekuita magumo eKEYNOTE-811 kupona kwese (OS) uye kufambira mberi-kusina kupona (PFS). Mvumo yaChivabvu 5, 2021, yakapihwa mushure mekuongorora kuongororwa kwechinguvana kwechinangwa chekupindura chiyero (ORR) uye nguva yekupindura (DOR). ORR neDOR zvakaongororwa mukutanga 264 randomized vatori vechikamu panguva iyoyo. Chinangwa chekupindura (ORR) chaiva 74% (95% CI: 66, 82) mu pembrolizumab pamwe nekemotherapy boka uye 52% (95% CI: 43, 61) mu placebo pamwe nekemotherapy boka (p-value <0.0001) . Nguva yepakati yekupindura yaive mwedzi 10.6 (kureba: 1.1 kusvika 16.5) uye 9.5 mwedzi (range: 1.4 kusvika 15.4) mumapoka akasiyana.

Ongororo yenguva pfupi yekuyedza yakanyoreswa yakazara nevatori vechikamu 698 yakaratidza kuti muchikamu chevarwere ve104 vane PD-L1 CPS <1, iyo hazard ratios (HR) yekupona kwese (OS) uye kufambira mberi-kusina kupona (PFS) yaive 1.41 ( 95% CI 0.90, 2.20) uye 1.03 (95% CI 0.65, 1.64) maererano.

Iyo yekuchengetedza mbiri yevarwere vanorapwa ne pembrolizumab uye trastuzumab + chemotherapy muKEYNOTE-811 yakanga yakafanana neyakagadzikwa kuchengetedza profiles yetrastuzumab + chemotherapy chete kana pembrolizumab monotherapy.

Chiyero chinokurudzirwa chepembrolizumab i200 mg mavhiki matatu ega ega kana 3 mg masvondo matanhatu ega ega kusvika kufambira mberi kwechirwere, huturu husingagoneki, kana kweanopfuura mwedzi makumi maviri nemana. Tonga pembrolizumab pamberi petrastuzumab uye chemotherapy kana zvikapihwa pazuva rimwe chete.