Keytruda for Gastric Cacner – pro
The antiPD-1 monoclonal antibody, pembrolizumab (MK-3475), demonstrated promising antitumor activity in advanced gastric cancer, results from the KEYNOTE-012 study presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. Among patients who were PD-L1positive, overall response rate (ORR), the primary end point, was 22.2% (95% CI: 10.1, 39.2) by central review and 33.3% (95% CI: 19.1, 50.2). In Keynote 059 study, there was manageable safety and promising antitumor activity for pembro alone and pembro + chemo in pts with G/GEJ cancer.
Based on this, on September 22.2017, The Food and Drug Administration (FDA) has granted accelerated approval to the immunotherapy drug pembrolizumab (Keytruda®) for use in some patients with advanced gastric (stomach) cancer.
Bang Y-J, Chung H-C, Shankaran V, et al. Relationship between PD-L1 expression and clinical outcomes in patients with advanced gastric cancer treated with the anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) in KEYNOTE-012. J Clin Oncol. 2015;33:(suppl; abstr 4001).
Z.A. Wainberg, KEYNOTE-059 Update: Efficacy and Safety of Pembrolizumab Alone or in Combination With Chemotherapy in Patients With Advanced Gastric … Annals of Oncology (2017) 28 (suppl_5): v605-v649.