FDA Approves Pembrolizumab for PD-L1+ Gastric Cancer
The FDA has approved pembrolizumab (Keytruda) for the treatment of patients with PD-L1–positive recurrent or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received 2 or more lines of chemotherapy, including fluoropyrimidine- and platinum-containing chemotherapy, and, if appropriate, HER2/neu-targeted therapy.
The approval is based on findings from the phase II KEYNOTE-059 study. In the study, 143 of 259 patients had PD–L1-positive tumors (combined positive score ≥1) and microsatellite stable tumor status or undetermined microsatellite instability or mismatch repair status. The overall response rate (ORR) in these patients was 13.3% (95% CI, 8.2-20.0), including a complete response (CR) rate of 1.4% and a partial response (PR) rate of 11.9%.The duration of response among the 19 responding patients ranged from 2.8+ to 19.4+ months. Responses were 6 months or longer in 11 (58%) patients and 12 months or longer in 5 (26%) patients.
The approval is based on findings from the phase II KEYNOTE-059 study. In the study, 143 of 259 patients had PD–L1-positive tumors (combined positive score ≥1) and microsatellite stable tumor status or undetermined microsatellite instability or mismatch repair status. The overall response rate (ORR) in these patients was 13.3% (95% CI, 8.2-20.0), including a complete response (CR) rate of 1.4% and a partial response (PR) rate of 11.9%.The duration of response among the 19 responding patients ranged from 2.8+ to 19.4+ months. Responses were 6 months or longer in 11 (58%) patients and 12 months or longer in 5 (26%) patients.
http://www.onclive.com/web-exclusives/fda-approves-pembrolizumab-for-pdl1-gastric-cancer
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