FDA Approves New Drug for Advanced Lung Cancer

Promising results from a clinical trial led by lung cancer specialist, Alan Sandler, M.D., director of Thoracic Oncology at Vanderbilt-Ingram Cancer Center, have helped in the effort to get a new drug approved by the Food and Drug Administration to fight an advanced form of the disease.

The trial involved the drug bevacizumab, now marketed as Avastin, being tested in nearly 900 patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC) who had not received any prior chemotherapy. The study was part of the Eastern Cooperative Oncology Group (ECOG), one of the largest clinical cancer research organizations in the United States, and involved over 150 other study sites across the country. The patients were randomized and half received the new drug in addition to chemotherapy; the other half of the group received chemotherapy alone, which is the standard treatment option.

Patients who received Avastin combined with chemotherapy lived, on average, about two months longer than the group who only received chemotherapy. Sandler said it might not sound like a huge improvement, but for patients with this advanced, and often deadly, form of lung cancer, it is a major advancement. “Patients overwhelmingly want to live longer. It is important to note, these numbers represent an ‘average;’ some patients may not achieve any benefit while some patients may receive a survival benefit far beyond the two-month average.”

In addition, the study also showed that some patients who received the drug plus chemotherapy saw their tumors shrink or go away altogether. Sandler said the results were groundbreaking.

“This is the first time in more than 10 years that we’ve seen an increase in survival in patients with metastatic, non-small cell lung cancer. More specifically, bevacizumab represents the first targeted agent, that when combined with chemotherapy in the chemotherapy-naïve setting, revealed an improvement in overall survival. We believe that this concept will ultimately translate into more patients being cured of their disease if we can get to them before it has spread,” said Sandler, who is also the medical director of Hematology and Oncology at Vanderbilt-Ingram.

Non-small cell lung cancer is the most common kind of the disease, with about 175,000 new cases diagnosed each year in the U.S. Each year, about 160,000 Americans die from the disease, which is more than the second, third, fourth and fifth most common cancers combined in the U.S.

The drug works by stopping the development of new blood vessels, which feed a tumor and allow it to grow. It is a humanized, monoclonal antibody that binds to or blocks a specific protein or pathway that is needed for blood vessel development. “It blocks VEGF, or vascular endothelial growth factor, which appears to be extremely important in new blood vessel development,” explained Sandler.

Because Avastin is directed against a specific target, Sandler said it primarily spares normal, healthy cells in the process, and therefore, side effects are not as severe as chemotherapy. “It is generally very well tolerated.” However, there are some unique side effects and Sandler said the most serious is bleeding from the primary lung tumor. “There were five patients who died secondary to a pulmonary hemorrhage that was felt to be treatment-related. It is a drug that works on blood vessels, and that is something that we need to pay close attention to,” he added.