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FDA Approves Frontline Pembrolizumab Regimen for Squamous NSCLC

Jason M. Broderick @jasoncology
Published: Tuesday, Oct 30, 2018

The FDA has approved first-line pembrolizumab (Keytruda) for use in combination with carboplatin and either paclitaxel or nab-paclitaxel (Abraxane) for the treatment of patients with metastatic squamous non–small cell lung cancer (NSCLC).

Two-hundred seventy-eight patients were treated in the pembrolizumab cohort and 281 patients received treatment in the chemotherapy-alone arm. In the pembrolizumab arm, 121 patients remained on treatment and 157 had discontinued. The primary reasons for discontinuing were progressive disease (n = 99) and adverse events (AEs; n = 48). In the chemotherapy-alone arm, 72 patients remained on treatment, with 208 having discontinued, primarily due to progression (n = 166) and AEs (n = 25).


Patient characteristics were well balanced at baseline between the 2 arms. In the pembrolizumab arm, the median age was 65.0 years (range, 29-87), 79.1% of patients were men, 73.7% had an ECOG performance status of 1, 7.2% had stable brain metastases, and 92.1% were current/former smokers. Additionally, 60.8% received paclitaxel as their taxane, 6.1% had prior thoracic radiation, and 1.8% had prior (neo)adjuvant therapy.

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