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.
The KEYNOTE-811 (NCT03615326) probatio multicenter, randomised, duplicatus caecus, placebo moderatus iudicium in aegris cum HER2 positivo progressu gastrico vel gastroesophageali coniunctione (GEJ) adenocarcinoma, qui systemicam theraphim pro metastatica morbo antea non recepit, approbatione nititur. de prae- certa analysi interim primae 264 aegris. Pembrolizumab 200 mg seu placebo aegris tribus hebdomadibus data est coniuncta cum trastuzumab et vel fluorouracil plus cisplatina vel capecitabina plus oxaliplatina.
Suprema responsionis rate (ORR) fuit primaria efficacia metrica in hoc studio adhibita, quae ab obcaecatae recensionis commissione independenter examinata est. OrR in bracchio pembrolizumab erat 74 centesimas (95 cento CI 66, 82) et in bracchio placebo erat 52 centesimas (95 percent CI 43, 61) (unum quadratum p-value 0.0001, peraeque significant). Mediana periodus responsionis (DoR) pro participibus cum pembrolizumab tractata erat 10.6 mensium (range 1.1+, 16.5+) et 9.5 mensium (range 1.4+, 15.4+) pro iis qui in bracchio placebo.
Responsio adversa responsionis profile nuntiavit in Study KEYNOTE-811 homines accipientes pembrolizumab notae pembrolizumab profile salutis aequant.
Adulti aegroti cum HER2 gastrico vel metastatico localiter progressi positivi gastrici vel GEJ adenocarcinoma capiant 200 mg per 3 septimanas vel 400 mg quaelibet 6 septimanae pembrolizumab in conjunctione cum trastuzumab et chemotherapy.
Reference: https://www.fda.gov/
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