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LGND and SRGN are mentioned on WSJ Interactive, in an article about Genentech !
Genentech Drug Is Viewed to Be Successful Against Breast Cancer
By RALPH T. KING JR.
Staff Reporter of THE WALL STREET JOURNAL
LOS ANGELES -- Genentech Inc. disclosed Sunday that its drug,
Herceptin, markedly slows progression of a virulent form of metastatic
breast cancer, marking the first evidence of success of gene-based
treatments against the disease.
The promising clinical results come amid a buzz of excitement at the
opening of the huge American Society of Clinical Oncology convention,
where more than 19,000 cancer researchers, doctors and drug-industry
officials have gathered.
Herceptin is one of a new generation of genetically engineered drugs expected to add precious months or years to the lives of cancer patients, without the toxic effects of chemotherapy or radiation.
The drug was tested on patients with a type of metastatic breast cancer that afflicts up to 30% of the 180,000 women diagnosed with the disease annually in the U.S. In combination with chemotherapy, Herceptin caused tumors to shrink substantially in 53% more women than those on chemotherapy alone. It also slowed progression of the disease by three months, to 7.6 months.
'A Big Effect'
"This is the biggest difference I've seen in advanced-stage breast cancer. This is a big effect," said Larry Norton, head of medical oncology at Memorial Sloan-Kettering Cancer Center in New York and one of the trial investigators.
In other hot developments, British drug maker Zeneca PLC is promoting
two recently released studies that indicate tamoxifen, which it sells as Novaldex, could help prevent breast cancer for certain women at high risk of the disease and improve chances that women who have had breast cancer can avoid a recurrence.
Drug makers, eager to capitalize on promising tests for their products, are wooing the medical professionals in conference rooms and at lavish soirees. Sunday night, drug giant Eli Lilly & Co. took over the Universal Studios amusement park and treated several thousand conventioneers to glitzy special-effects shows, an all-you-can-eat Mexican buffet and plenty of free beer and wine.
Herceptin could be on the market by the end of the year, assuming the
Food and Drug Administration gives its approval based on the trial results reported Sunday. Researchers say some prostate, bone and bladder cancer patients could also benefit.
Pricey Treatment
Still, investigators cautioned that the drug didn't benefit a majority of patients, all of whom have tumors with an overactive gene called Her2 that spurs tumor growth. In the Herceptin-only trial, a mere 16% showed a positive response. The drug also carries a slightly increased risk of heart failure in patients on the chemotherapy drug anthracycline. Also, given its likely cost of around $10,000 per year, health insurers may prove reluctant to foot the bill.
Yet patients who benefited are euphoric. "I wouldn't call it a miracle, but it's pretty damn good," says Margaret O'Donnell, 59 years old, a San Francisco lawyer who was told she had two years to live when she was diagnosed with breast cancer in 1991. After 2 1/2 years on Herceptin, her condition is stable. "It has added years to my life, and I hope it's still adding years."
Herceptin is actually the second cancer drug for Genentech, which along with Idec Pharmaceuticals Inc. launched Rituxan for non-Hodgkin's lymphoma in November. Seragen Inc. is seeking FDA approval for another lymphoma drug next month. Ligand Pharmaceuticals Inc. has a group of so-called retinoid drugs in trials that show promise in attacking various tumors, analysts say.
"This is a foot in the door. These are new ways of doing things and there are dozens of molecules out there being tested," said I. Craig Henderson, a breast-cancer expert who is chief executive of Sequus Pharmaceuticals Inc. "We didn't get responses as good as these back when we started testing chemotherapy."
One concern among researchers here is that good news about drugs that
could help certain sufferers of certain cancers will get distorted in the translation to the lay public, leading to confusion and disappointment.
Many Differences
The reality, researchers here say, is that there likely will never be a single "cure" for cancer because there is no single kind of cancer. In the case of breast cancer, for example, there are several different types of breast cancer cells, which respond to different kinds of treatment. Treatment could be different depending on a woman's age, whether or not she has had children, and whether she or close relatives have had cancer.
"It's clear over the past two or three months that there's a great deal of confusion," Harmon Eyre, executive vice president for research and medical affairs at the American Cancer Society, said during a Sunday morning news conference called by Zeneca to highlight recent tamoxifen studies.
Zeneca officials worry about confusion in part because rival Eli Lilly has early trials that suggest its raloxifene, already approved for osteoporosis in older women, also acts to reduce breast cancer risk.
Zeneca and Lilly have agreed to support a major trial to begin later this year that would test the two drugs head to head for effectiveness in breast cancer prevention, Norman Wolmark, chairman of the National Surgical Breast and Bowel Project said Sunday.
Zeneca last month applied to the FDA for approval to market tamoxifen
for prevention of breast cancer and expects the agency to act within the next six months. In studies publicized before the conference, researchers found that tamoxifen cut by 45% the incidence of breast cancer in a trial of 13,388 women at high risk for the disease. A separate study found that women who received tamoxifen after treatment for certain kinds of "estrogen receptor positive" breast tumors had substantially better rates of long term survival.
No Magic Bullet
In the meantime, there is no simple answer for women asking whether they should take tamoxifen or raloxifene. And there is no magic bullet for women already diagnosed with severe breast cancer.
Herceptin was tested in two Phase 3 clinical trials including 691 patients. In one trial that included chemotherapy, women taking the agent Taxol had a rate of tumor shrinkage more than double that of the chemotherapy-only group. In the second trial, with Herceptin alone, 4% of patients had complete tumor shrinkage, and 12% had shrinkage of more than 50%. Ginger Empey, 53 years old, a Bakersfield, Calif., nurse, said she had already failed two chemotherapy regimens when she heard about tests for Herceptin headed by Dennis Slamon at the University of California at Los Angeles School of Medicine.
Her cancer had spread to her liver and she was dying. "Most people with liver metastasis don't make three months," she said. She started taking the drug in mid 1995, and after eight weeks, the spots on her liver were "significantly reduced," she said. They continued to shrink until last October when her condition stabilized.
"I'm thankful for every breath, Ms. Empey said.
--Rhonda L. Rundle contributed to this article. |
