Should the indication for the monotherapy use of pembrolizumab in CPS ≥ 1 gastric/GEJ adenocarcinoma (third-line or greater) be maintained pending final results of ongoing studies?

Given two negative trials of pembrolizumab as monotherapy, are any of the applicant’s proposed alternative trials appropriate to confirm clinical benefit in patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed cell death 1 ligand 1 (PD-L1) [combined positive score (CPS≥1)] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, human epidermal growth factor receptor 2 (HER2)/neu-targeted therapy?

Keytruda, Opdivo’s Retention Of Hepatocellular Carcinoma Indication May Depend On Ongoing Studies

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