FDA Approves Pembrolizumab for Metastatic, Locally Advanced Esophageal or Gastroesophageal Carcinoma


Investigators found a statistically significant improvement in both overall survival and progression-free survival for patients who received pembrolizumab with chemotherapy.

Pembrolizumab (Keytruda, Merck Sharp & Dohme Corp) has been approved by the FDA in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) carcinoma who are not candidates for surgical resection or definitive chemoradiation.

The approval is based on KEYNOTE-590, a multicenter, randomized, placebo-controlled trial that enrolled 749 patients with metastatic or locally advanced esophageal or GEJ junction carcinoma. Programmed death-ligand 1 (PD-L1) status was centrally determined in tumor specimens in all patients, and participants were randomized to receive either pembrolizumab in combination with cisplatin and fluorouracil or a placebo with cisplatin and fluorouracil.

According to a press release, the main efficacy outcome measures were overall survival (OS) and progression-free survival (PFS). The investigators found a statistically significant improvement in both measures for patients who received pembrolizumab with chemotherapy. Specifically, the median OS was 12.4 months for the pembrolizumab arm compared to 9.8 months for the chemotherapy arm. Similarly, the median PFS was 6.3 and 5.8 months, respectively.

The most common adverse reactions reported in patients who received pembrolizumab included nausea, constipation, diarrhea, vomiting, stomatitis, fatigue or asthenia, decreased appetite, and weight loss. The recommended pembrolizumab dose for esophageal cancer is 200 mg every 3 weeks or 400 mg every 6 weeks, according to the press release.

“Because esophageal cancer generally has poor survival rates, new first-line therapies are urgently needed for these patients,” said Peter Enzinger, MD, director of the Center for Esophageal and Gastric Cancer at the Dana-Farber/Brigham and Women’s Cancer Center, in the press release. “Today’s approval of this indication for Keytruda introduces a new option, which has shown a superior survival benefit compared to FU and cisplatin alone, for newly diagnosed patients with locally advanced or metastatic esophageal or GEJ carcinoma that is not amenable to surgical resection or definitive chemoradiation, regardless of PD-L1 expression status and tumor histology.”


FDA Approves Merck’s Keytruda (pembrolizumab) Plus Platinum- and Fluoropyrimidine-Based Chemotherapy for Treatment of Certain Patients With Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction (GEJ) Carcinoma [news release]. Merck; March 23, 2021. https://www.merck.com/news/fda-approves-mercks-keytruda-pembrolizumab-plus-platinum-and-fluoropyrimidine-based-chemotherapy-for-treatment-of-certain-patients-with-locally-advanced-or-metastatic-esophageal-or-g/. Accessed March 23, 2021.

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