MSD’s immunotherapy Keytruda has received approval from the European Commission (EC) in combination with chemotherapy as a first line treatment for certain oesophageal cancer patients.
The EC has authorised Keytruda (pembrolizumab) in combination with platinum- or fluoropyrimidine-based chemotherapy for the initial treatment of patients with locally advanced unresectable or metastatic oesophageal cancer or HER2-negative gastroesophageal junction (GEJ) cancer in adults whose tumours express PD-L1.
The approval is based on data from the Phase III KEYNOTE-590 trial, which enrolled 749 patients with locally advanced unresectable or metastatic oesophageal or GEJ cancer, who were not eligible for surgery or definitive chemoradiation.
In this trial, Keytruda plus 5-fluorouracil (5-FU) and cisplatin reduced the risk of death by 27% and reduced the risk of disease progression or death by 35% compared with 5-FU and cisplatin alone.
A pre-specified analysis of patients whose tumours expressed PD-L1 showed Keytruda plus 5-FU and cisplatin reduced the risk of death by 38% and reduced the risk of disease progression or death by 49% versus chemotherapy alone.
In addition to the overall survival (OS) and progression-free survival (PFS) data, Keytruda plus 5-FU and cisplatin-treated patients demonstrated an objective response rate (ORR) of 51.1%, with a complete response (CR) rate of 5.9% and a partial response (PR) rate of 45.2%.
Again, this was an improvement on 5-FU and cisplatin alone, with patients in this group demonstrating ORR of 26.9%, with a CR rate of 2.5% and a PR rate of 24.4%.
“Keytruda plus chemotherapy is the first anti-PD1 therapy approved in Europe in this first-line setting, allowing these patients to be treated with immunotherapy earlier in the course of their treatment,” said Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories.