ASCO: Biotech Won't Be Forgotten

Genentech, Genzyme and Cell Genesys are among those presenting data at the cancer conference.
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Despite the fact that Big Pharma is making a big push at this year's American Society of Clinical Oncology annual meeting, biotech companies aren't about to sit out the show.

For one,

Genzyme

(GENZ)

said a late-stage clinical trial showed that Campath exhibited significantly higher overall and complete response rates over chlorambucil in previously untreated patients with progressive B-cell chronic lymphocytic leukemia.

Genzyme said 83% of patients on Campath responded to the drug, compared with 56% of those on chlorambucil. The company said 24% of the study participants getting Campath had a complete response, vs. 2% of the chlorambucil patients. Chlorambucil is considered by many to offer the most tolerable safety profile for previously untreated patients.

The phase III trial had 297 participants. The study's primary goal was to examine progression-free survival and the secondary targets included safety, response rate and overall survival.

Genzyme made the announcement along with a unit of Berlex Laboratories, a U.S. affiliate of Germany's

Schering AG

(SHR)

. Chlorambucil is marketed as Leukeran by

GlaxoSmithKline

(GSK) - Get Report

.

Campath received accelerated approval in 2001 and is currently indicated for the treatment of B-cell chronic lymphocytic leukemia in patients who have been treated with alkylating agents and who have failed fludarabine therapy. Once the final data from the study's primary endpoint of progression-free survival are available, Genzyme and Berlex expect to file an application seeking to expand the product's label.

Chronic lymphocytic leukemia is the most prevalent form of adult leukemia, affecting about 120,000 people in Europe and the U.S.

Elsewhere, new data from 4,000 patients show that Avastin enables patients with advanced colorectal cancer to live longer without their disease worsening, Switzerland's

Roche

said. Roche markets the drug with

Genentech

(DNA)

, a U.S. biotech company in which it owns a majority stake.

The data represent the largest data set on Avastin ever available and were presented at the ASCO meeting Saturday in Atlanta.

An international study and its U.S. counterpart investigated the use of Avastin in advanced colorectal cancer in combination with standard chemotherapies. The U.S. arm of the study found the median length of time without the cancer growing was 10.2 months, regardless of the chemo used.

In 2002, colorectal cancer was the third-most common cancer, with about 1 million new cases worldwide. More than 50% of people diagnosed with colorectal cancer will die of the disease, according to estimates, Roche said.

Avastin is currently approved for treating cancer of the colon or rectum along with intravenous 5-fluorouracil-based chemotherapy. Specifically, the drug is used for patients diagnosed with metastatic colorectal cancer for the first time. Metastatic cancer has spread to other organs in the body.

Roche and Genentech are investigating the use of Avastin in various tumor types, including those found in the breast, lungs, pancreas and ovaries.

Separately,

Cell Genesys

(CEGE)

reported what it called encouraging long-term follow-up data from a mid-stage trial of Gvax immunotherapy for chronic myelogenous leukemia. The company said adding Gvax to

Novartis'

(NVS) - Get Report

Gleevec reduced persistent leukemic disease in 10 of 19 patients in a study.

"We continue to be encouraged by the results of this phase II trial in CML, in particular by the achievement of sustained molecular responses when Gvax is added to ongoing

Gleevec therapy," said Joseph Vallner, the president and chief operating officer of Cell Genesys. "Gvax immunotherapy in our view may represent an important new treatment strategy for CML."

The median duration of Gleevec therapy prior to patients entering the study was three years. Patients were given four injections of Gvax at three-week intervals over nine weeks and then followed for nine months or longer. To date, all of the patients have tolerated the treatment well and completed the planned nine months of follow-up.

Clinical trials of Gvax cancer immunotherapies are under way for multiple types of cancer, including prostate cancer and pancreatic cancer.