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.
Isivivinyo se-KEYNOTE-811 (NCT03615326), isilingo esilawulwa nge-placebo kwiziguli ezine-HER2 positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma eyayingakaze ithole ukwelashwa kwesistimu yesifo se-metastatic, ithole imvume ngokususelwa ekuhlaziyweni kwesikhashana okucacisiwe kweziguli zokuqala ezingama-264. I-Pembrolizumab 200 mg noma i-placebo yanikezwa iziguli njalo emavikini amathathu ngokuhlangana ne-trastuzumab kanye ne-fluorouracil kanye ne-cisplatin noma i-capecitabine kanye ne-oxaliplatin.
Izinga lokuphendula lilonke (i-ORR) kwakuyimethrikhi yokuqala yokusebenza eyayisetshenziswe kulolu cwaningo, eyahlolwa yikomidi lokubuyekeza elizimele elingaboni. I-ORR engalweni ye-pembrolizumab ibingamaphesenti angama-74 (amaphesenti angama-95 we-CI 66, 82) kanti engalweni ye-placebo ibingamaphesenti angama-52 (amaphesenti angama-95 we-CI 43, 61) (inani elilodwa le-p-value 0.0001, elibalulekile ngokwezibalo). Isikhathi esiphakathi sokuphendula (i-DoR) sabahlanganyeli abaphathwe nge-pembrolizumab kwakuyizinyanga eziyi-10.6 (ububanzi 1.1+, 16.5+) nezinyanga eziyi-9.5 (ububanzi obungu-1.4 +, 15.4+) kulabo abasengalweni ye-placebo.
Iphrofayili yokuphendula engemihle ibikwe ku-Study KEYNOTE-811 abantu abathola i-pembrolizumab ifana nephrofayili yokuphepha epembrolizumab eyaziwayo.
Iziguli zabantu abadala ezinesisu esithuthukile noma esine-metastatic HER2 esiswini noma i-GEJ adenocarcinoma kufanele zithathe ama-200 mg njalo emavikini amathathu noma ama-3 mg njalo emavikini ayisithupha epembrolizumab ngokuhlangana ne-trastuzumab ne-chemotherapy.
Inkomba: https://www.fda.gov/
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