TPS183 Background: Pembrolizumab (pembro) is a humanized monoclonal antibody against PD-1 that prevents PD-1 from interacting with PD-L1 and PD-L2 and permits activation of an antitumor immune response. In KEYNOTE-012, pembro showed a manageable safety profile and a 22% ORR in pts with advanced gastric cancer. The randomized, open-label, phase 3 KEYNOTE-061 study (NCT02370498) is designed to compare the efficacy and safety of pembro with those of standard-of-care paclitaxel in the second-line treatment of advanced gastric cancer. Methods: KEYNOTE-061 is designed for patients with metastatic or unresectable gastric or GEJ adenocarcinoma that progressed after first-line treatment with platinum and fluoropyrimidine doublet chemotherapy. Patients with HER2/neu-positive tumors are eligible if they have documented progression on a regimen that also included trastuzumab. Other key eligibility criteria include measurable disease per RECIST v1.1, ECOG PS 0-1, no chemotherapy within 2 wk of first dose of study drug, and provision of a newly obtained or archival tumor sample for assessing PD-L1 status. Eligible pts are randomized 1:1 to receive pembro 200 mg Q3W or paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of each 28-d cycle. Treatment will continue until disease progression, intolerable toxicity, refusal by pt or investigator, or completion of 24 mo of therapy (pembro arm only). Pts in the pembro arm who have a CR after ≥ 24 wk may discontinue after ≥ 2 doses following initial CR. Clinically stable pts who progress per RECIST v1.1 may continue pembro at the discretion of the investigator until a confirmatory CT scan performed ≥ 4 wk later. Response will be assessed every 6 wk for the first 6 mo and every 12 wk thereafter per RECIST v1.1 by central review and per RECIST adapted for immunotherapy response patterns. AEs will be assessed throughout treatment and for 30 d thereafter (up to 90 d for serious AEs). Primary efficacy end points are PFS per RECIST v1.1 and OS in pts with PD-L1+ tumors. Secondary end points include PFS and OS in all pts, time to progression, ORR, and duration of response. Enrollment in KEYNOTE-061 is ongoing and will continue until up to 720 pts are enrolled. Clinical trial information: NCT02370498.
Quality of Life in Flags Trial a Randomized, Comparative, Open Label, Multicenter, Phase 3 of S-1 + Cisplatin (CS) Compared to 5-Fu + Cisplatin (CF) in Untreated advanced Gastric Cancer (AGC) Patients
