Avastin Can Increase Survival Times for Lung Cancer Patients

The cancer medication Avastin, manufactured by California-based biotechnology company Genentech, can provide a "modest but significant" increase in survival times for certain lung cancer patients, according to "unexpected" preliminary results from a large clinical trial released on Monday, the Wall Street Journal reports (Hamilton, Wall Street Journal, 3/15). FDA last year approved Avastin as a treatment for colorectal cancer.

The trial, sponsored by the National Cancer Institute, included 878 patients with advanced nonsmall cell lung cancer, half of whom received Avastin in combination with the chemotherapy medications paclitaxel and carboplatin and half of whom received only the chemotherapy treatments (Pollack, New York Times, 3/15). Trial participants in the Avastin group received double the dose recommended for use in colorectal cancer patients.

The trial found that about half of participants who received Avastin lived at least 12.5 months, compared with 10.2 months for those who only received the chemotherapy medications, a 23% difference. The trial results "bolstered some of the more optimistic hopes for Avastin," which "researchers and investors alike" have considered a potential treatment for "so-called solid tumors," the Journal reports (Wall Street Journal, 3/15).

Genentech also is testing Avastin as a treatment for breast, kidney, ovarian and other cancers (New York Times, 3/15). Genentech officials said that they plan to hold discussions with FDA about approval of Avastin as a lung cancer treatment (Wall Street Journal, 3/15). Genentech will present the full results of the trial in May at the annual meeting of the American Society of Clinical Oncology (New York Times, 3/15).

Scott Saxman of NCI said that the institute released the preliminary results to help lung cancer patients make informed decisions about treatment (Gellene, Los Angeles Times, 3/15).

According to Saxman, a small number of trial participants who received Avastin -- fewer than 3% -- experienced life-threatening bleeding from the lungs (New York Times, 3/15). An earlier trial had found Avastin led to six serious cases of bleeding from the lungs, four of which were fatal (Wall Street Journal, 3/15). According to the Los Angeles Times, "many investors wrote the drug off as a lung cancer treatment after that clinical trial, which took place five years ago" (Los Angeles Times, 3/15).

The most recent trial excluded patients likely to have a high risk for bleeding from the lungs, such as those with a history of the condition and those with a form of lung cancer called squamous cell carcinoma (Wall Street Journal, 3/15). Such patients account for about one-third of those with advanced nonsmall cell lung cancer, according to cancer experts (New York Times, 3/15).

According to the Medical Technology Stock Letter, Genentech "is the best at scrutinizing failed clinical trials and figuring out how to design trials that will show that the failed drug candidate actually works" (Los Angeles Times, 3/15).

The preliminary results of the most recent trial of Avastin "present the first study combining a targeted biologic therapy with chemotherapy to show an overall survival improvement in the first-line nonsmall cell lung cancer setting," Genentech Chief Medical Officer Hal Barron said in a statement (Sarkar, San Francisco Chronicle, 3/15).

Alan Sandler, lead investigator of the trial and an associate professor at Vanderbilt Medical Center, said that the trial marked the first large study in which survival times for patients with nonsmall cell lung cancer -- the most common form of the disease -- exceeded 12 months (New York Times, 3/15). Sandler also said that bleeding from the lungs might occur in some patients when Avastin "works too well" and causes tumors to collapse and destroy blood vessels, adding that researchers have begun to examine methods to prevent the condition (Szabo, USA Today, 3/15).

Roy Herbst, chief of thoracic oncology at the M.D. Anderson Cancer Center, said that in recent years nine or 10 medications, such as Iressa and Tarceva, have failed to increase survival times for patients in similar trials. Herbst, who has consulted for Genentech, said, "The fact that this trial is positive is actually an extraordinary result" (New York Times, 3/15). He added, "It makes me feel like everything we are doing in lung cancer is worthwhile" (USA Today, 3/15).

However, Michael Perry of the University of Missouri, an investigator in the trial and owner of about 160 Genentech shares, said, "This is a clear single to center field. It's not a home run, a triple, not even a double," adding, "But in the field of lung cancer, where strikeouts are common, getting a solid hit is something to be proud of."

Geoffrey Porges of Sanford C. Bernstein also raised concerns about the benefits of Avastin and the number of trial participants who experienced bleeding from the lungs (New York Times, 3/15). Porges said, "The survival benefit looks like it is at the very low end of what is needed to achieve statistical significance" (Los Angeles Times, 3/15).