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Keytruda Extends Survival in Lung Cancer Study

Merck’s drug is superior to chemotherapy in certain patients

The recently approved lung cancer treatment pemobrolizumab (Keytruda, Merck) provided superior overall survival (OS) compared with chemotherapy in a late-stage study of patients with advanced disease whose tumors produce programmed death ligand 1 (PD-L1), which is associated with increased risk of the disease.

According to Reuters, the U.S. drugmaker said patients taking the approved 2-mg dosage of pemobrolizumab and those taking an experimental 10-mg dose had longer OS compared with those taking docetaxel, a standard treatment for non–small-cell lung cancer (NSCLC), the most common form of lung cancer. Pemobrolizumab thereby met the main goal of the study.

Patients whose tumors had especially high levels of PD-L1 also went longer without a progression of disease than those taking docetaxel, Merck said. Those whose tumors expressed PD-L1, but not at high levels, did not show such a statistically significant benefit in progression-free survival. The safety of pemobrolizumab was consistent with what had been seen in previous trials among lung cancer patients, Merck said in a release that included only summary "topline" information from the results. More detailed data from the study will be provided soon, Merck said, adding that it will ask the FDA later this year to add the new data to the drug's package insert label.

U.S. regulators in October approved pemobrolizumab on an accelerated basis for patients with advanced NSCLC whose tumors produce PD-L1. The approval was contingent on the company providing more detailed data in the future on pemobrolizumab’s safety and effectiveness. The medication and a similar treatment called nivolumab (Opdivo, Bristol-Myers Squibb) are antibodies designed to block the interaction between PD-L1 and the protein programmed death 1 (PD-1), whose natural function is to put checks on the immune system. By blocking the interaction, the drugs aim to enable the patient's own immune system to recognize and therefore attack the cancer. Wall Street analysts expect cancer immunotherapies to earn combined annual sales of more than $20 billion by 2020.

Source: Reuters, October 27, 2015.

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