Phase 2a study of ALD518 for treatment of non small cell lung cancer (NSCLC) symptoms

Alder Biopharmaceuticals announced that patients with late-stage non-small cell lung cancer (NSCLC) showed improvement in cancer-related anemia and symptoms of the disease in a Phase 2a clinical trial of ALD518. This double-blind, placebo-controlled, randomized study was conducted in 124 patients with advanced NSCLC at 43 sites worldwide. All patients had demonstrated weight loss of more than 5 percent of body weight in the preceding three months and hemoglobin levels greater than 7 g/dL. Patients were randomized across the placebo and three dose cohorts. Patients received injections of ALD518 or placebo every eight weeks for the 24-week duration. Efficacy data was measured at 12 weeks, while safety data continued to be collected through 24 weeks. After 12 weeks of treatment with the anti-inflammatory therapeutic, 58 percent of patients who received ALD518 experienced hemoglobin level increases from less than 11 g/dL to more than 12 g/dL, while no patients receiving placebo experienced this increase. In addition, patients who received ALD518 had an average lean body mass loss of 0.19 kg, compared to an average loss of 1.5 kg in those who received placebo. Additional symptoms of the disease such as fatigue were also reduced in patients who received ALD518.

ALD518 is a novel asialated, humanized monoclonal antibody directed against IL-6.

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