Phase III CLL8 trial shows Rituxan plus FC chemotherapy improves patients with CLL

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 51^st 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

Sponsored by Roche and conducted by the German CLL Study Group, CLL8 was a global, multi-center, randomized, open-label, Phase III study that enrolled 817 patients with previously untreated (first-line) CD20-positive CLL. The primary endpoint for CLL8 was PFS and secondary endpoints were overall survival (OS), event-free survival, duration of response, response rate, complete response and toxicity. CLL8 evaluated Rituxan plus FC chemotherapy compared with FC chemotherapy alone and met the primary endpoint of improving PFS. The primary study analysis was reported at ASH 2008.

As previously reported, Grade 3 or greater adverse events occurred more frequently in the Rituxan plus FC arm, compared to the FC arm, in particular neutropenia, but this did not result in an increased infection rate. In CLL8, the most common adverse events that occurred more often in the Rituxan plus FC arm included blood and lymphatic system disorders, infections and neoplasms. Grade 3 or greater events that occurred more often in the Rituxan plus FC arm included hematologic toxicity (56 percent vs. 39 percent), neutropenia (34 percent vs. 21 percent) and leukocytopenia (24 percent vs. 12 percent).

CLL8 was one of two studies submitted for review by the U.S. Food and Drug Administration (FDA) in an application for a potential label for Rituxan plus FC in CLL. The companies are committed to making Rituxan plus FC an FDA-approved option for people with CLL.