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Wall Street Journal reports Genentech working on "next generation" Herceptin!
Targeted Cancer Drugs Gain Backers
By RON WINSLOW and JEANNE WHALEN
June 5, 2006
ATLANTA -- Several large pharmaceutical companies reported promising results for new cancer drugs, signaling their intention to join biotechnology firms in the emerging transformation of treatment for the disease.
New data on experimental agents from Bristol-Myers Squibb Co., GlaxoSmithKline PLC and Wyeth presented at the meeting of the American Society of Clinical Oncology here are expected to add to the growing arsenal of so-called targeted drugs doctor have available to fight cancer. A study on Pfizer Inc.'s recently approved drug Sutent confirmed its value against patients with advanced kidney cancer.
Despite their promise, however, the drugs generally provide some benefit for only some patients with the cancers they target. Cures, especially for patients with advanced disease, remain elusive.
During the past few years, the cancer world has been energized by new compounds, exemplified by Genentech Inc.'s breast-cancer drug Herceptin and Novartis SA's Gleevec for chronic myelogenous leukemia, or CML, and other rare cancers. The drugs work by disrupting signaling pathways that enable tumor cells to grow and spread. Except for Gleevec, most of these drugs have emerged from biotech labs, but their potential effect on the disease -- and their financial success -- have gotten the attention of traditional drug makers.
"The Big Pharmas are back in force," said Roy Herbst, a lung cancer researcher at M.D. Anderson Cancer Center at the University of Texas, Houston.
Glaxo, the world's second-biggest drug maker by sales, behind Pfizer, estimates that the annual market for cancer drugs will jump to $70 billion by 2009 from $42 billion today.
Glaxo is a small player in cancer, with about £1 billion ($1.9 billion) in oncology sales last year, representing about 5% of its total revenue of £21.7 billion. But the company has several cancer drugs in late-stage clinical development and aims to boost its ranking in that field.
Its leading candidate is Tykerb, a treatment for an aggressive form of breast cancer. Data presented at the meeting showed that Tykerb was effective at treating this kind of breast cancer in patients who don't respond to Herceptin, giving hope to women with otherwise limited treatment options.
When taken with a standard chemotherapy treatment in a clinical study, Tykerb nearly doubled the time to 8.5 months before the average patient's breast cancer got worse compared with chemotherapy alone. No significant extra side effects were experienced with Tykerb and chemotherapy, compared with those taking just chemotherapy.
Bristol-Myers, which was the industry's dominant cancer company during the 1990s, is counting on an experimental drug calls dasatinib to help it regain its stature in the disease. Dasatanib's initial indication is expected to be for patients with CML who fail to respond or develop resistance to Gleevec.
An advisory panel to the Food and Drug Administration recommended approval Friday. Additional data presented Saturday offered more evidence of its benefit in Gleevec-resistant patients.
Doctors and analysts expect Glaxo and Bristol-Myers will seek to prove these two drugs are effective first-line treatments and to eventually compete against Herceptin and Gleevec, respectively. But both Genentech and Novartis are building defenses. Genentech is developing a next-generation Herceptin it hopes will avoid some cardiovascular side effects associated with the drug. Novartis said yesterday that it plans to file an application by year's end for its next-generation Gleevec compound.
Brian Druker, the Oregon Health & Science University, Portland, and Howard Hughes Medical Institute researcher who led development of Gleevec for CML, reported yesterday that after five years, 18% of patients who started on the drug had developed resistance and 5% were unable to take it because of side effects. But overall survival for Gleevec patients after five years was 89%, findings that Robert Mayer, a researcher at Dana-Farber Cancer Institute, Boston, termed "really remarkable."
Researchers reported a drug called temsirolimus being developed by Wyeth improved overall survival in kidney-cancer patients by about 3.5 months to 10.9 months compared with patients given standard treatment with interferon.
Side effects such as rashes and increased blood sugar were associated the Wyeth drug, but researchers said they weren't severe.
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