OBJECTIVES: Pembrolizumab in combination with lenvatinib obtained an European marketing authorization on November 15^th, 2021 for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. An Early Access Program (EAP) post-marketing authorization for this indication has been granted on March 17^th, 2022 by HAS.

METHODS: We conducted a prospective non-interventional study from April 12, 2022 to August 26, 2022. Hospitals that prescribed pembrolizumab as part of the EAP had to submit information while requesting access to pembrolizumab and during discontinuation. This included some patient characteristics, and date of discontinuation.

RESULTS: During this period, 433 patients from 191 French centers were included in the EAP. Keytruda was prescribed for the majority of patients at 200mg (97,2%). The median (IQR) age of patients was 70,1 (65 - 75) years. Most patients were overweight or obese (56.1%), while 39.3% had a normal BMI. 94.5% of patients had metastatic endometrial cancer at the time of the access request and metastases sites were predominantly lymph node (58.1%), peritoneum (52.6%), and lung (41.4%). In this interim analysis, 15 patients permanently discontinued pembrolizumab (progression n=9, death = 4, other =2).

CONCLUSIONS: This is the first real-world study of pembrolizumab in advanced endometrial cancer in France to our knowledge. Patients were administered pembrolizumab in accordance with the SmPC. Furthermore, the population characteristics were comparable to the overall population, and particularly to the French sub-group, in the KEYNOTE-775 trial. The large number of patients and centers who were able to access novel therapy before final reimbursement demonstrates the success of the EAP program in France.