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Rituxan Plus Fludarabine and Cyclophosphamide Improves Overall Survival in Patients with CLL

Strategic Insights

— 2 min read

Genentech, a wholly owned member of the Roche Group, and Biogen Idec recently announced that three-year follow-up data from the pivotal Phase III CLL8 trial showed that Rituxan, in combination with fludarabine and cyclophosphamide (FC) chemotherapy, significantly improved overall survival in patients with previously untreated chronic lymphocytic leukemia (CLL). The trial, sponsored by Roche and conducted by the German CLL Study Group, enrolled 817 patients with first-line CD20-positive CLL. The primary endpoint of the trial was progression-free survival (PFS), and secondary endpoints included overall survival (OS), event-free survival, duration of response, response rate, complete response, and toxicity.

Key Takeaways:

  • The three-year follow-up data from the CLL8 trial showed that 87.2 percent of patients with previously untreated CLL who received Rituxan plus FC were alive, compared to 82.5 percent of patients who received FC alone (p=0.012).
  • The median survival has not yet been reached, with a median progression-free survival (PFS) of 51.8 months observed in the Rituxan plus FC arm, compared to 32.8 months in the FC-alone arm (p=0.012).
  • 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, such as hematologic toxicity, neutropenia, and leukocytopenia, occurred more frequently in the Rituxan plus FC arm, but did not result in an increased infection rate.
  • The safety profile of Rituxan plus FC was consistent with those previously reported for Rituxan.
  • Supplemental new drug application for Rituxan plus FC is pending review with the U.S. Food and Drug Administration (FDA).
  • Rituxan is a therapeutic antibody that targets the CD20 protein on the surface of cancerous and normal B-cells.

Statistics:

  • 87.2 percent of patients who received Rituxan plus FC were alive after more than three years of follow-up (37.7 months).
  • 82.5 percent of patients who received FC alone were alive after more than three years of follow-up (37.7 months).
  • Median progression-free survival (PFS) was 51.8 months in the Rituxan plus FC arm.
  • Median PFS was 32.8 months in the FC-alone arm.
  • Grade 3 or greater hematologic toxicity occurred in 56 percent of patients in the Rituxan plus FC arm, compared to 39 percent in the FC-alone arm.

Sources:

  • 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
  • American Cancer Society. Chronic Lymphocytic Leukemia (CLL): A Guide for Patients.
  • Biogen Idec. About CLL.
  • Genentech. About CLL.

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