FDA Approves Pembrolizumab for Advanced Esophageal/GEJ Cancer

The FDA has approved pembrolizumab (Keytruda) for use in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma who are ineligible for surgical resection or definitive chemoradiation.

The regulatory decision was based on data from the KEYNOTE-590 (NCT03189719), which enrolled a total of 749 patients with metastatic or locally advanced esophageal or gastroesophageal junction carcinoma who were ineligible for surgical resection or definitive chemoradiation.

Participants were randomized 1:1 to receive either pembrolizumab plus cisplatin/fluorouracil or placebo with cisplatin/fluorouracil. Treatment was administered until either intolerable toxicity or progressive disease. The primary outcome measures for the trial included overall survival (OS) and progression-free survival (PFS), per investigator assessment and RECIST v1.1 criteria.

Results indicated that pembrolizumab plus chemotherapy led to a statistically significant improvement in both OS and PFS. The median OS in the investigative arm was 12.4 months (95% CI, 10.5-14.0) vs 9.8 months (95% CI, 8.8-10.8) in the control arm (HR 0.73; 95% CI, 0.62-0.86; P <.0001). Additionally, the median PFS with pembrolizumab/chemotherapy was 6.3 months (95% CI, 6.2-6.9) vs 5.8 months with chemotherapy alone (95% CI, 5.0-6.0), (HR 0.65; 95% CI, 0.55-0.76; P<.0001).

Regarding safety, the common adverse effects experienced by patients who received the pembrolizumab combination included nausea, constipation, diarrhea, vomiting, stomatitis, fatigue/asthenia, decreased appetite, and weight loss.

Reference

FDA approves pembrolizumab for esophageal or GEJ carcinoma. News release. FDA. March 22, 2021. Accessed March 22, 2021. http://bit.ly/31908Di

This article was originally published on OncLive.