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FDA Approves Pembrolizumab for Advanced Esophageal and GEJ Carcinoma Treatment
On March 22, 2021, the FDA approved pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy, for the treatment of patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) carcinoma.
The approval of pembrolizumab was based on the KEYNOTE-590 multicenter, randomized, placebo-controlled trial, which enrolled 749 patients with metastatic or locally advanced esophageal or GEJ junction carcinoma who were not candidates for surgical resection or definitive chemoradiation. PD-L1 status was centrally determined in tumor specimens in all patients using the PD-L1 IHC 22C3 pharmDx kit.
Study participants were randomized via 1:1 ratio to receive pembrolizumab in combination with cisplatin and fluorouracil or placebo with cisplatin and fluorouracil, until experiencing signs of unacceptable toxicity or disease progression.
Overall, findings presented a significant improvement in in OS and PFS for patients randomized to receive pembrolizumab with chemotherapy (modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ).
Median OS was 12.4 months (95% CI = 10.5, 14.0) for the pembrolizumab arm versus 9.8 months (95% CI = 8.8, 10.8) for the chemotherapy arm (hazard ratio = 0.73; 95% CI = 0.62, 0.86; p < 0.0001). Median PFS was 6.3 (95% CI = 6.2, 6.9) and 5.8 months (95% CI = 5.0, 6.0), respectively (hazard ratio = 0.65; 95% CI = 0.55, 0.76; p < 0.0001).
The most common (≥20%) adverse reactions associated with the pembrolizumab combination included nausea, constipation, diarrhea, vomiting, stomatitis, fatigue/asthenia, decreased appetite, and weight loss. -Alexis Hyams
Source: US Food and Drug Administration. FDA approves pembrolizumab for esophageal or GEJ carcinoma. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-esophageal-or-gej-carcinoma. Accessed March 23, 2021.
