The Food and Drug Administration has approved pembrolizumab (Keytruda) for patients with recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1, as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
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FDA approval was based on results of two clinical trials: KEYNOTE-180 and KEYNOTE-181. KEYNOTE-181 was a randomized, open-label, active-controlled trial of 628 patients with recurrent, locally advanced, or metastatic esophageal cancer who progressed on or after one prior line of systemic treatment for advanced or metastatic disease. Patients who received pembrolizumab had a median overall survival of 10.3 months, compared with 6.7 months for patients who received control drugs.
In KEYNOTE-180, a single-arm, open-label trial of 121 patients with esophageal cancer who progressed after two prior lines of treatment, patients who had a PD-L1 combined positive score of at least 10 had an overall response rate of 20%, with response durations ranging from 4.2 to over 25.1 months, and with 71% of those patients having a response time over 6 months.
Adverse reactions reported in KEYNOTE-180 and –181 were similar to those in previous trials involving pembrolizumab in patients with melanoma and non–small cell lung cancer. The most common reactions were fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain.
The PD-L1 IHC 22C3 pharmDx kit was approved as the companion diagnostic device, the FDA said.
Find the full press release on the FDA website.