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Genentech Stops Enrolling Patients in Study

Posted on: Friday, 23 September 2005, 15:00 CDT

SOUTH SAN FRANCISCO, Calif. -- The maker of a promising ovarian cancer drug said Friday it stopped enrolling patients in a study because of gastrointestinal perforations.

Genentech Inc. said five out of 44 patients given Avastin developed the problem, a known possible risk of using the drug, but said that was a higher than expected number. The trial was expected to enroll 53 patients with ovarian cancer who had not responded to other chemotherapy.

Patients already enrolled in the trial can choose to continue the treatment or drop out of the study. Genentech decided to halt enrollment after talks with the Food and Drug Administration. Its shares fell nearly 3 percent in afternoon trading.

The FDA approved the drug last year for advanced colon cancer, but Avastin is also being studied to treat prostate, kidney and pancreatic cancer.

Avastin has been one of the most highly touted drugs in Genentech's portfolio and was the first success story for hopes of attacking tumors by starving their blood supply. It is the only FDA-approved drug that does this, and many doctors have been using it "off label" against a variety of cancer types, based on success reported two years ago against advanced colon cancer.

Dr. David Spriggs, chief of solid tumors at Memorial Sloan-Kettering Cancer Center in New York, one of the places where the ovarian cancer study was being conducted, said the problem could be a direct result of the drug's ability to kill tumor cells that have replaced healthy bowel tissue, leading to a dead area that then perforates.

"What I'm afraid of is it's because it works so well. It's probably the best drug since Taxol for ovarian cancer," he said.

None of the other "targeted" drugs like Erbitux, Iressa or Tarceva work the same way, and should not share the problem seen with Avastin, he and other cancer experts said. AstraZeneca PLC makes Iressa, Genentech makes Tarceva, ImClone Systems Inc. makes Erbitux.

Hal Barron, Genentech's chief medical officer, said the company didn't expect these results to affect plans to study Avastin in earlier-stage ovarian cancer or other cancers.

Genentech said patients in this study had more advanced disease, which typically involves the bowel, and had received more prior chemotherapy than in previous clinical trials of Avastin in ovarian cancer.

Avastin sales in the United States increased 85 percent to $245.7 million for the quarter ended June 30, from $133 million in the same period a year ago.

Genentech shares fell $2.58, or 2.9 percent, to $85.42 in afternoon trading on the New York Stock Exchange, down from a recent 52-week high of $94.99.

Source: Associated Press/AP Online

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