Avastin Study Supports New Use

Genentech Inc.’s Avastin prolonged the lives of lung cancer patients in a large clinical trial, the National Institutes of Health said Monday, sending shares of the company up nearly 25%.

Avastin has been approved for treating colon cancer but is being studied for others, including metastatic lung cancer.

The NIH said results of the clinical trial of 878 patients showed that people who received Avastin along with chemotherapy drugs had a median survival of 12.5 months, compared with 10.2 months for those who received only chemotherapy.

Alan B. Sandler of Vanderbilt University said Avastin was the first drug since the mid-1990s to improve survival in previously untreated lung cancer patients. Sandler was one of the academics who led the clinical study.

“This is very exciting,” he said. “In the not-too-distant future, patients will have a new treatment option.”

The cost of treating the disease probably would increase as well: Based on the dose used in the clinical study, a lung cancer patient would pay $8,800 a month for Avastin.

The NIH said the committee overseeing the trial recommended stopping it and releasing preliminary results because the trial met its goal of improving survival. More details will be presented in May at the annual meeting of the American Society of Clinical Oncology. The study was sponsored by the National Cancer Institute, a unit of the NIH.

Scott Saxman, a senior investigator with the National Cancer Institute, said the government made preliminary results available so patients could make informed decisions about treatments.

“This is an important, positive trial, and we need to make sure that people have the information,” he said.

Heather Wakelee, a Stanford University oncologist, said the clinical trial results were the best that had been seen for previously untreated metastatic lung cancer. Wakelee was one of the academics who administered Avastin to patients as part of the trial.

“For the first time, we have broken the one-year barrier for advanced non-small-cell lung cancer,” she said. “Two months doesn’t sound like much, but we’re talking about a disease where steps forward have been very small. This is a very significant jump.”

Genentech said it would seek Food and Drug Administration approval to market Avastin as a lung cancer treatment, based on the study. Hal Barron, Genentech’s senior vice president and chief medical officer, said the company was “surprised and excited by the findings.”

“We never expect all our trials to work,” he said. “We certainly had hopes.”

With 10-month sales of $554 million in 2004, its first year on the market, Avastin is an important driver of Genentech’s growth. On Monday, shares of South San Francisco-based Genentech moved up $10.92 to $55 on Nasdaq.

Avastin is an intravenous drug that slows the proliferation of new blood vessels that feed tumors. Without a blood supply, tumors die.

The worst side effect seen in the trial was life-threatening or fatal bleeding, chiefly from the lungs, the NIH said. The bleeding occurred infrequently but was more common in patients receiving Avastin, the NIH said.

Patients with squamous cell carcinomas or with lung cancer that had spread to the brain were excluded from the trial. In a previous clinical study, patients with squamous cell tumors had a higher risk of serious bleeding from the lung after taking Avastin and 6% of them died. In fact, many investors wrote the drug off as a lung cancer treatment after that clinical trial, which took place five years ago.

“It almost spelled doom for the drug,” the Medical Technology Stock Letter reported Monday. 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.”

About 40% of non-small-cell lung cancer patients fall into the groups excluded from the study reported Monday, shrinking the potential market for Avastin. The NIH said 172,570 Americans would be diagnosed this year with lung cancer, the leading cause of cancer death.

Geoffrey Porges, an analyst at Sanford Bernstein & Co., said Wall Street overreacted to the Avastin news. “The survival benefit looks like it is at the very low end of what is needed to achieve statistical significance,” he said.

Porges said he wanted to see data on side effects and the length of remissions experienced by people on Avastin, which slows down tumor growth for a while but not permanently.

Previously untreated lung cancer patients experience remissions of about four months on standard chemotherapy regimens, according to Genentech.