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FDA Approves Pembrolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Squamous NSCLC

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On October 30, 2018, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with carboplatin and either paclitaxel or nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) as first-line treatment of metastatic squamous non–small cell lung cancer (NSCLC).

Approval was based on KEYNOTE-407, a randomized, multicenter, double-blind, placebo-controlled trial in 559 patients with metastatic squamous NSCLC, regardless of programmed cell death ligand 1 tumor-expression status, who had not previously received systemic therapy for metastatic disease. Patients were randomly assigned (1:1) to receive pembrolizumab at 200 mg or placebo in combination with carboplatin and investigator’s choice of either paclitaxel every 3 weeks or nab-paclitaxel weekly on a 3-week cycle for 4 cycles followed by pembrolizumab or placebo. Patients continued on pembrolizumab or placebo until disease progression, unacceptable toxicity, or a maximum of 24 months. 

Key Findings of KEYNOTE-407

The main efficacy outcome measures were overall survival, progression-free survival, and overall response rate as assessed by blinded independent review. The trial demonstrated statistically significant improvements in all three of these outcomes for patients receiving pembrolizumab plus chemotherapy compared with those receiving placebo plus chemotherapy. 

The median overall survival was 15.9 and 11.3 months for the pembrolizumab/chemotherapy and placebo/chemotherapy arms, respectively (hazard ratio [HR] = 0.64, 95% confidence interval [CI] = 0.49–0.85; = .0017). The median progression-free survival was 6.4 and 4.8 months for the pembrolizumab/chemotherapy and placebo/chemotherapy arms, respectively (HR = 0.56, 95% CI = 0.45–0.70; < .0001). 

The analysis of overall response rate was limited to the initial 204 patients randomized. The overall response rates were 58% and 35%, favoring the pembrolizumab-containing arm (difference of 23.6%; 95% CI = 9.9–36.4; P= .0008). The estimated median response durations were 7.2 and 4.9 months, respectively.

The most common adverse reactions in at least 20% of patients who received pembrolizumab on KEYNOTE-407 were fatigue/asthenia, nausea, constipation, diarrhea, vomiting, pyrexia, decreased appetite, rash, cough, dyspnea, alopecia, and peripheral neuropathy.

The recommended pembrolizumab dose for metastatic squamous NSCLC is 200 mg intravenously every 3 weeks, prior to chemotherapy when given on the same day, until disease progression, unacceptable toxicity, or 24 months after initiation.

The FDA granted this application Priority Review. For full prescribing information for pembrolizumab, see the package insert.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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