The US Food and Drug Administration has approved Pembrolizumab for adjuvant treatment following resection and platinum-based chemotherapy in patients with NSCLC (non-small cell lung cancer). This approval has been based on the results from the phase 3, multicenter, randomized and placebo-controlled KEYNOTE-091 trial.
In the trial, 1177 patients who had undergone resection with or without standard adjuvant chemotherapy were randomized into two treatment arms. One received 200mg intravenous pembrolizumab every three weeks for up to a year and other were treated with placebo every three weeks for up to a year. Patients in treatment arm 1 who received adjuvant chemotherapy had a median DFS was 58.7 months while patients in placebo arm receiving adjuvant chemotherapy had a median DFS of 34.9 months.
The adverse reactions observed in KEYNOTE-09 were gradually similar to those occurring in patients with NSCLC receiving KEYTRUDA as a single agent. The recommended dose of pembrolizumab is 200 mg every three weeks or 400 mg every six weeks until recurrence of disease or up to 12 months. This review has been conducted under Project Orbis which is an initiative of the FDA Oncology Center of Excellence.
Dr. Gregory Lubiniecki, vice president, oncology global clinical development, Merck Research Laboratories, said in a press release, “Six years ago, Keytruda was the first anti-PD-1 therapy approved for the first-line treatment of metastatic non-small cell lung cancer and has changed the way metastatic disease is treated. Today’s approval marks the fifth indication for Keytruda in non-small cell lung cancer and the first indication for Keytruda in patients with resected stage IB (T2a ≥4 cm), II, or IIIA disease following adjuvant chemotherapy.” “This is an important milestone as we continue our efforts to pursue meaningful advances for patients with non-small cell lung cancer,” he added.
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