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FDA Approves Anti-PD1 Regimen for Squamous NSCLC
The FDA has granted approval to pembrolizumab (Keytruda; Merck) in combination with carboplatin and paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous non–small-cell lung cancer (NSCLC). This is the first time an anti-PD1 regimen has been authorized for first-line use in squamous NSCLC regardless of tumor PD-L1 status.
“Today’s approval expands our current lung cancer indications to include combination treatment in patients with squamous cell carcinoma, a type of lung cancer that is particularly difficult to treat. Approval by the FDA has the potential to mean that KEYTRUDA can be used to improve survival for more patients with this debilitating disease,” said Roger M. Perlmutter, MD, PhD, President, Merck Research Laboratories, Rahway, NJ, in a press release about the approval (October 2018).
The approval was based on results from the phase 3 KEYNOTE-407 clinical trial, in which patients, regardless of PD-L1 status, received pembrolizumab plus chemotherapy or chemotherapy alone. The pembrolizumab plus chemotherapy regimen significantly improved overall survival, reducing the risk for death by 36% compared with chemotherapy alone (hazard ratio, 0.64; 95% confidence interval, 0.49-0.85; P = .0017).
“The results that support this approval from the KEYNOTE-407 trial demonstrate the potential of KEYTRUDA in combination with chemotherapy in patients with squamous non-small cell lung cancer, regardless of PD-L1 expression,” Balazs Halmos, MD, MS, Director of the Thoracic Oncology, Montefiore Einstein Center for Cancer Care, Bronx, NY, said in the press statement.
“With this important approval, more patients will have the opportunity to benefit from immunotherapy,” he added.
Immune-mediated adverse reactions associated with pembrolizumab include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. The drug can also potentially cause severe or life-threatening infusion-related adverse reactions.—Janelle Bradley
