Immuno-Oncology Resource Center
Immuno-Oncology Resource Center
April 11, 2019
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FDA expands Keytruda approval for non-small cell lung cancer

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The FDA expanded the approval of pembrolizumab to include the first-line treatment of patients with stage III non-small cell lung cancer who are not able to undergo surgical resection or definitive chemoradiation, as well as those with metastatic disease.

The approval applies to patients with no EGFR or ALK genomic aberrations whose tumors express PD-L1, defined as tumor proportion score of 1% or greater as determined by an FDA-approved test.

The FDA previously approved pembrolizumab (Keytruda, Merck) — an anti-PD-1 therapy — as monotherapy for first-line treatment of patients with metastatic NSCLC whose tumors had PD-L1 tumor proportion scores of 50% or higher.

The agency based the expanded approval on results of the randomized, phase 3 KEYNOTE-042 trial, which included 1,274 patients with stage III or stage IV NSCLC who had received no prior systemic treatment for metastatic disease. All patients in the trial had PD-L1 tumor proportion scores of 1% or higher.

Researchers randomly assigned patients 1:1 to pembrolizumab 200 mg via IV every 3 weeks or investigator’s choice of a carboplatin-containing regimen with either paclitaxel or pemetrexed.

Results showed pembrolizumab prolonged median OS among patients with tumor proportion scores of 1% or higher (16.7 months vs. 12.1 months; HR = 0.81; 95% CI, 0.71-0.93), 20% or higher (17.7 months vs. 13 months; HR = 0.77; 95% CI, 0.64-0.92), and 50% or higher (20 months vs. 12.2 months; HR = 0.69; 95% CI, 0.56-0.85).

Researchers reported no significant differences in PFS or overall response rate between the pembrolizumab or chemotherapy groups.

The most common adverse reactions reported among at least 10% of patients who received single-agent pembrolizumab in KEYNOTE-042 included fatigue, decreased appetite, dyspnea, cough, rash, constipation, diarrhea, nausea, hypothyroidism, pneumonia, pyrexia and weight loss.