Top Line: Is pembrolizumab an effective alternative to chemotherapy as second-line treatment for advanced esophageal cancer?
The Study: Here we have publication of final survival outcomes of the Keynote-181 trial. Over 600 patients with advanced squamous cell carcinoma or adenocarcinoma of the esophagus that progressed on one prior line of standard therapy were randomized to pembrolizumab monotherapy or second-line chemotherapy (paclitaxel, docetaxel, or irinotecan). Most patients had metastatic disease (~92%), squamous cell histology (~64%), and a low (< 10) PD-L1 combined positive score (CPS) (~65%). The primary endpoint was overall survival in three groups: those with PD-L1 CPS ≥ 10, those with squamous cell carcinoma, and the overall population. As you might expect, median OS was significantly longer with pembro in those with PD-L1 CPS ≥ 10 (6.7 → 9.3 months), and OS at 12 months was more than doubled (20.4 → 43%). There was, statistically, no difference in median OS among patients with SCC receiving pembro (8.2 vs 7.1 months). However, there was a noticeable difference in the rate of OS at 12 months (39.4 vs 24.9%). Furthermore, patients with SCC and CPS ≥ 10 saw the biggest survival benefit with pembro. In the overall population (~⅔ with PD-L1 CPS < 10), there was no difference in median OS (7.1 months).TBL: Pembrolizumab is more effective than second-line chemotherapy in patients with advanced esophageal squamous cell carcinoma and a PD-L1 CPS ≥ 10. | Kojima, J Clin Oncol 2020