RITUXAN + FC SIGNIFICANTLY IMPROVED PFS IN FIRST-LINE AND PREVIOUSLY TREATED CLL 1,2

Primary endpoint: progression-free survival (PFS), defined as the time from randomization to progression, relapse, or death, as determined by investigators.

*Randomized, multicenter, open-label study comparing FC alone or in combination with RITUXAN for up to 6 cycles in patients with previously untreated CLL (n=817). Patients received fludarabine 25 mg/m2/day and cyclophosphamide 250 mg/m2/day on days 1, 2, and 3 of each cycle, with or without RITUXAN. Seventy-one percent of CLL patients received 6 cycles and 90% received at least 3 cycles of RITUXAN-based therapy. 1,2

Primary endpoint: progression-free survival (PFS), defined as the time from randomization to progression, relapse, or death, as determined by an independent review committee.

Randomized, multicenter, open-label study comparing FC alone or in combination with RITUXAN for up to 6 cycles in patients with previously treated CLL (n=552). Patients received fludarabine 25 mg/m2/day and cyclophosphamide 250 mg/m2/day on days 1, 2, and 3 of each cycle, with or without RITUXAN. Seventy-one percent of CLL patients received 6 cycles and 90% received at least 3 cycles of RITUXAN-based therapy. 1,2

Treatment considerations

These trials were not designed or powered to detect a significant difference in PFS by age category. However, exploratory analyses defined by age suggest no observed benefit with the addition of RITUXAN to FC chemotherapy in previously untreated CLL patients 70 years of age or older and in previously treated CLL patients 65 years of age or older.

CLL8: SELECT IMPORTANT SAFETY INFORMATION

RITUXAN IN COMBINATION WITH FC FOR PREVIOUSLY UNTREATED CLL

  • In the CLL8 study of patients with previously untreated CLL, detailed safety data collection was limited to Grade 3 and 4 adverse reactions and serious adverse reactions
  • Grade 3 or 4 adverse reactions that occurred more frequently in patients treated with R-FC vs. FC were infusion reactions (9% in the R-FC arm), neutropenia (30% vs. 19%), febrile neutropenia (9% vs. 6%), leukopenia (23% vs. 12%), and pancytopenia (3% vs. 1%)
  • The frequency of prolonged neutropenia for patients who received R-FC vs. FC was 8.5% and 5.8% respectively. For patients who did not have prolonged neutropenia, the frequency of late-onset neutropenia for patients who received R-FC vs. FC was 14.8% and 4.3%, respectively
  • Grade 3 or 4 adverse reactions that occurred more frequently in R-FC-treated patients ≥70 years of age compared to younger patients were neutropenia (44% vs. 31%), febrile neutropenia (16% vs. 6%), pancytopenia (7% vs. 2%), and anemia (5% vs. 2%)

REACH: SELECT IMPORTANT SAFETY INFORMATION

RITUXAN IN COMBINATION WITH FC FOR PREVIOUSLY TREATED CLL

  • Grade 3 or 4 adverse reactions that occurred more frequently in patients treated with R-FC vs. FC were infusion reactions (7% in R-FC arm), neutropenia (49% vs. 44%), febrile neutropenia (15% vs. 12%), thrombocytopenia (11% vs. 9%), hypotension (2% vs. 0%), and hepatitis B (2% vs. <1%)
  • The frequency of prolonged neutropenia for patients who received R-FC vs. FC was 24.8% and 19.1% respectively. For patients who did not have prolonged neutropenia, the frequency of late-onset neutropenia for patients who received R-FC vs. FC was 38.7% and 13.6%, respectively
  • Grade 3 or 4 adverse reactions that occurred more frequently in R-FC-treated patients ≥70 years of age compared to younger patients were neutropenia (56% vs. 39%), infections (30% vs. 14%), anemia (21% vs. 10%), thrombocytopenia (19% vs. 8%), and pancytopenia (7% vs. 2%)
  • Fifty-nine percent of R-FC–treated patients experienced an infusion reaction

FC=fludarabine and cyclophosphamide; PFS=progression-free survival; CLL=chronic lymphocytic leukemia; R=RITUXAN.

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