August 2021: Pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, fluoropyrimidine-, and platinum-containing chemotherapy has been granted accelerated approval by the Food and Drug Administration for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Iyo KEYNOTE-811 (NCT03615326) kuyedza, multicenter, yakasarudzika, yakapofomara, yakapetwa-inodzorwa-placebo-inotongwa muvarwere vane HER2 yakanaka yepamusoro gastric kana gastroesophageal junction (GEJ) adenocarcinoma uyo akange asati ambowana systemic kurapa kwechirwere chemastastatic, akagamuchira mvumo pane yakatarwa nguva yekuongorora kwevarwere 264 vekutanga. Pembrolizumab 200 mg kana placebo yakapihwa kuvarwere vhiki nhatu dzese pamwe chete netrastuzumab uye ingava fluorouracil pamwe cisplatin kana capecitabine pamwe oxaliplatin.
Iyo yakazara yekupindura mwero (ORR) yaive yekutanga metric inoshanda yakashandiswa muchidzidzo chino, iyo yakaongororwa nekapofumadzwa yakazvimiririra yekuongorora komiti. Iyo ORR iri pembrolizumab ruoko yaive 74 muzana (95 muzana CI 66, 82) uye mune ruoko rwe placebo yaive 52 muzana (95 muzana CI 43, 61) (imwe-mativi p-kukosha 0.0001, inoverengeka yakakosha). Nguva yepakati yekupindura (DoR) yevatori vechikamu yaibatwa nepembrolizumab yaive mwedzi gumi nematanhatu (renji 10.6+, 1.1+) nemwedzi 16.5 (renji 9.5+, 1.4+) yeavo vari munzvimbo yeplacebo.
Iyo yakaipa mhinduro mhinduro yakataurwa muChidzidzo KEYNOTE-811 vanhu vanogamuchira pembrolizumab inofanidza inozivikanwa pembrolizumab chengetedzo profil.
Varwere vakuru vane nzvimbo yepamusoro isingachinjiki kana metastatic HER2 yakanaka gastric kana GEJ adenocarcinoma vanofanirwa kutora 200 mg masvondo matatu ega ega kana 3 mg masvondo matanhatu ese epembrolizumab pamwe chete netrastuzumab uye chemotherapy.
Referensi: https://www.fda.gov/
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