News From Study Could Increase Demand for Rituxan
Idec Pharmaceuticals Corp. and Genentech Inc. could see demand rise for their Rituxan cancer drug on new data showing that when combined with chemotherapy, it helps patients with aggressive lymphoma survive.
An interim analysis of a 400-patient study conducted by European partner Roche Holding AG indicates that the combination therapy prolongs survival in elderly patients with an aggressive form of non-Hodgkin’s lymphoma, a disease that afflicts more than 350,000 people in the U.S.
The research, presented today at a medical conference, could help convince physicians to prescribe Rituxan as part of a first-line therapy. The drug is currently approved for a slower-growing form of the disease, and only for those patients who either don’t respond to chemotherapy or radiation or who have relapsed after earlier success with those treatments.
“This news should have a very profound, near-term impact on sales,” said Laurence Blumberg, president of Blumberg Capital Management. “It seems to me that oncologists will have to very rapidly adopt the use of Rituxan” in patients with aggressive non- Hodgkin’s lymphoma.
The research was one of the most anticipated among investors and physicians attending the annual meeting of the American Society of Hematology in San Francisco, where the study was presented.
First approved by the U.S. Food and Drug Administration in November 1997 for so-called low-grade NHL, Rituxan generated more than $260 million in U.S. sales last year. About 60,000 people in the U.S. are diagnosed each year with non-Hodgkin’s lymphoma, with about 35,000 of those in the low-grade, slower-growing category. The remainder are patients that the new study addresses.
Made from a genetically engineered antibody found in mice, the drug works by binding to a site on certain human cells that are common in tumors and then marking them as targets for the body’s own immune system to attack.
The new study examined 328 of 400 previously untreated patients who were divided into two groups: those receiving a standard four-drug chemotherapy known as CHOP and those receiving CHOP together with Rituxan.
After one year, 68% of those on the combination therapy survived without any “events,” defined as progression of the disease or relapse, death or switching to a new treatment. For those only on chemotherapy, 49% survived without events.
“The combination [of Rituxan] and chemotherapy will become the standard of treatment” for the disease, said Bertrand Coiffier, the principal investigator in the study.
About 10% of patients taking Rituxan and CHOP experienced a serious, though reversible, reaction to the therapy. Most of the reactions happened after the first infusion, and the combination therapy didn’t appear to cause a significant increase in reactions compared to chemotherapy alone, the companies said.
A U.S. trial examining the combination therapy continues, though Genentech said it temporarily stopped enrolling patients in its own trial that mirrors the one conducted in Europe by Roche.
The Roche study is expected to continue for about another year, though it’s possible the companies could use the interim data as the basis for an application seeking approval from the U.S. Food and Drug Administration, said Dr. Gwen Fyfe, Genentech’s senior director of oncology.
“This is a huge improvement in survival. We didn’t expect to see such remarkable data this early in the course of the trial,” Fyfe said. “Our big message is that Rituxan benefits patients the most when given early and in combination therapy.”
