Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG;
OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) today announced that
three-year follow up of the pivotal Phase III CLL8 trial showed Rituxan
plus fludarabine and cyclophosphamide (FC) chemotherapy helped patients
in the trial with previously untreated chronic lymphocytic leukemia
(CLL) live longer than FC alone. No new safety signals were observed and
the safety profile was consistent with those previously reported for
Rituxan. The data were presented today at the 51st Annual
Meeting of the American Society of Hematology (ASH) in New Orleans.
“These data showed that at three years of follow up, more patients who
received Rituxan with fludarabine and cyclophosphamide chemotherapy were
alive compared with those who received the chemotherapy combination
alone,” said Hal Barron, M.D., executive vice president, Global
Development and chief medical officer, Genentech. "This is important
because CLL is incurable and potential treatment options that may help
people live longer are needed."
New data from the Phase III CLL8 study showed that 87.2 percent of
patients with previously untreated CLL who received Rituxan plus FC were
alive after more than three years of follow up (37.7 months) compared to
82.5 percent of patients who received FC alone>
“Rituxan was the first targeted B-cell therapy approved for cancer in
the U.S. and these new data once again illustrate Rituxan’s ability to
improve patient outcomes,” said Greg Reyes, M.D., Ph.D., senior vice
president, Oncology Research and Development, Biogen Idec. “These
three-year data are exciting for people living with CLL.”
CLL8 Survival Results: First-Line Treatment with Fludarabine,
Cyclophosphamide, and Rituximab Improves Overall Survival in Previously
Untreated Patients with Advanced CLL: Results of a Randomized
Phase III Trial on Behalf of an International Group of Investigators and
the German CLL Study Group (Abstract #535) – Monday, December 7,
2009, 2:45 p.m. CST, Hall F