NEW YORK, Dec 7 (Reuters) - Cephalon Inc’s Treanda was as effective in treating non-Hodgkin’s lymphoma as the standard chemotherapy regimen with far less toxicity, according to interim analysis of a late-stage study that could pave the way for the drug’s use as an initial treatment for the disease.
Treanda, known chemically as bendamustine, is approved to treat non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of a treatment regimen that includes Rituxan — a widely used cancer drug sold by Genentech Inc DNA.N and Biogen Idec Inc (BIIB.O). Approval as an initial, or first-line, treatment could significantly expand sales of Cephalon’s CEPH.O new cancer medicine.
“In practice I would say that a lot of doctors will be convinced to use and to consider bendamustin/rituxan from now on as first-line treatment,” Dr Mathias Rummel, the study’s lead investigator from University Hospital of Giessen in Germany, said in an interview.
The Phase III “non-inferiority” study compared Treanda plus Rituxan with the commonly used chemotherapy regimen known as CHOP plus Rituxan as a first-line treatment for the slowly developing, or indolent, form of cancer.
With data from 462 patients available for analysis in the three-year trial, Treanda was at least as effective as the CHOP regimen in the study’s primary goal of progression-free survival, with a trend toward superiority that had not reached statistical significance, said Rummel, who was awaiting data from 50 more patients.
“It appears even superior and it is clearly and for very sure not inferior,” said Rummel, who presented the data at the American Society of Hematology scientific meeting in San Francisco on Sunday.
In other measures of effectiveness the two regimens appeared to be very similar.
In the Treanda group, 41 percent achieved complete remission and the overall response rate was 94 percent. Thirty-two percent in the CHOP group reached complete remission with a 93 percent overall response rate.
But Treanda had a far superior side-effect profile.
No patients taking the Cephalon drug lost their hair compared with 91 percent on CHOP — a clear measure of toxicity.
Some 14 percent of Treanda patients experienced a significant drop in white blood cell count, which greatly increases the risk of infection, compared with 38 percent on CHOP. Five percent of Treanda patients in the study required treatment with a white blood cell booster, such as Amgen Inc’s (AMGN.O) Nuepogen, compared with 21 percent of CHOP patients.
Rummel said he expects oncologists will soon become very comfortable using Treanda in place of CHOP “because clearly this treatment makes less side effects and less complications and this is of course a big advantage for the doctor and the patient.”
JP Morgan analyst Chris Schott said in a research note that the latest data should help boost Treanda revenue.
“We continue to view first-line indolent NHL as a significant potential upside driver to Treanda (sales) forecasts,” he said. (Editing by Matthew Lewis)