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Merck’s Melanoma Drug, Keytruda, Receives Lung Cancer Indication

The FDA’s approval include a requirement that tumors be tested for PD-LD1

Pembrolizumab (Keytruda, Merck) has received clearance for an expansion of its label to include an indication for treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express PD-L1 and who have experienced disease progression on or after platinum-containing chemotherapy. The approval also includes a companion diagnostic, manufactured by Agilent Technologies, that measures the target protein level. The approval makes the product the first and only anti-PD1 therapy approved for both squamous and non-squamous metastatic NSCLC. Pembrolizumab had been previously approved as a treatment for melanoma.

In KEYNOTE-001, the clinical study supporting the FDA Breakthrough Designation for KEYTRUDA and this approval, KEYTRUDA demonstrated an overall response rate of 41 percent (n=25/61) in patients with a PD-L1 expression tumor proportion score (TPS) of 50 percent or more; all responses were partial responses (95% CI, 29, 54). Eighty-four percent (n=21/25) of those who responded had ongoing responses, including 11 patients with ongoing responses of six months or longer. Immune-mediated adverse reactions occurred with KEYTRUDA, including pneumonitis, colitis, hepatitis, hypophysitis, hyperthyroidism, hypothyroidism, type 1 diabetes mellitus, and nephritis. 

As noted by Bloomberg Business, the green light for pembrolizumab comes seven months after a related therapy, nivolumab (Opdivo, Bristol-Myers Squibb), was approved for patients with squamous NSCLC. Bristol-Myers’s drug doesn’t come with a requirement that tumors be tested for PD-L1.

According to Reuters, Merck has priced pembrolizumab at $12,500 per month, which works out to $150,000 per year. Wall Street analysts expect cancer immunotherapies like pembrolizumab to have a combined annual sales of over $20 billion by 2020, says Reuters.

Source: Merck, October 2, 2015; Bloomberg Business, October 2, 2015; Reuters, October 2, 2015

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