Alder Biopharmaceuticals reports positive data from ALD518 Phase 2a clinical trial for NSCLC

Jun 7 2010

Alder Biopharmaceuticals Inc. today 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, a monoclonal antibody directed against interleukin-6 (IL-6).

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. The data were presented in two posters at the annual meeting of the American Society of Clinical Oncology.

"Underlying inflammation leads to many of the problems faced by cancer patients, such as cachexia and anemia," said Michael Schuster, M.D., director of the hematologic malignancy program at Stony Brook University Medical Center and author of the posters.  "In anemia, for example, we see considerable concern around erythroid growth factors and patients needing blood transfusions. A new therapeutic approach in the area has the potential to be very helpful."

James R. Rigas, M.D., director of the comprehensive thoracic oncology program at Norris Cotton Cancer Center, added, "Cachexia in patients with lung cancer is extremely disabling and associated with significant morbidity. The prevention of loss of lean body mass observed in NSCLC patients with cachexia treated with ALD518 suggests that blocking interleukin 6 is a promising approach to treating this unmet medical need."

Safety data through 24 weeks showed the treatment to be safe and well-tolerated in patients. Infusions of ALD518 did not lead to serious infusion reactions or evident immunogenicity. There were 52 deaths in the study, all of which investigators considered to be due to the progression of the disease and unrelated to the study. Other reasons for discontinuation from the study were determined to be unrelated to the treatment.

"In addition to the impressive data presented in these posters, we were pleased to learn from the investigators that some patients were able to resume their normal daily activities after treatment with ALD518," said Randall Schatzman, president and CEO of Alder Biopharmaceuticals. "We consider the data to support the continued investigation of ALD518 as a unique approach to treating cancer patients."

The 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.

Data about the anemia results were presented by Dr. Schuster in poster 46B, titled, "ALD518, a humanized anti-IL-6 antibody, treats anemia in patients with advanced non-small cell lung cancer (NSCLC): Results of a Phase II, randomized, double-blind, placebo-controlled trial." Data about lean body mass loss and other disease symptoms were presented by Dr. Rigas in poster 45A titled, "Effect of ALD518, a humanized anti-IL-6 antibody, on lean body mass loss and symptoms in patients with advanced non-small cell lung cancer (NSCLC): Results of a Phase II randomized, double-blind safety and efficacy trial."