The FDA approved Merck’s KeytrudaR (pembrolizumab), the company’s anti-PD-1  therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression, with no EGFR or ALK genomic tumor aberrations. With this new indication, Keytruda is now the only anti-PD-1 therapy to be approved in the first-line treatment setting for these patients, according to officials at Merck.

In addition, the FDA approved a labeling update to include data from the Keynote-010 Phase III clinical trial in the second-line or greater treatment setting for patients with metastatic NSCLC whose tumors express PD-L1 as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. A Merck spokesperson noted that patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. In metastatic NSCLC, Keytruda is approved for use at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Keytruda, a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells, blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

“Keytruda improved survival, compared to traditional chemotherapy, in patients with non-small cell lung cancer whose tumors express high levels of PD-L1,” said Roger M. Perlmutter, M.D., Ph.D., president, Merck Research Laboratories. “The approval of Keytruda for the first-line treatment of metastatic non-small cell lung cancer has the potential to change the treatment landscape for these patients.”

“With this new indication, Keytruda can now be a first treatment option instead of chemotherapy for patients with metastatic non-small cell lung cancer whose tumors express high levels of PD-L1,” added Roy S. Herbst, M.D., Ph.D., professor of medicine and chief of medical oncology, Yale Cancer Center and Smilow Cancer Hospital at Yale New Haven. “These data reaffirm the importance of testing for PD-L1 expression in non-small cell lung cancer in order to identify those patients who are most likely to benefit from treatment with Keytruda.”

Keytruda had previously been approved for the treatment of patients with unresectable or metastatic melanoma and for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

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