Trial design
SAWYER TRIAL: STUDIED PREVIOUSLY UNTREATED CLL 1,2
SAWYER was a 2-part, open-label study to investigate RITUXAN HYCELA vs RITUXAN (rituximab), when both were combined with FC
Patient Characteristics:
- Median age was 60 years
- Median BSA was 1.9 m2 (range: 1.41-2.42 m2)
- 35% female and 65% male
Trial results
PRIMARY ENDPOINT 1
- Primary Endpoint: Non-inferiority of the PK profile of RITUXAN HYCELA vs RITUXAN (rituximab)
ADDITIONAL ENDPOINT: INVESTIGATOR-ASSESSED RESPONSE RATES 1
Adverse reactions
SAWYER TRIAL: ADVERSE REACTIONS 1
Incidence of adverse reactions in ≥5% of patients with previously
untreated CLL receiving RITUXAN HYCELA or RITUXAN (rituximab) in
combination with FC
Select SAWYER Safety Information
- The incidences of adverse reactions were balanced between the two treatment groups (96% RITUXAN HYCELA vs. 91% RITUXAN), and the common adverse reactions (occurring in ≥20% of patients in any arm) were infections, neutropenia, nausea, thrombocytopenia, pyrexia, anemia, vomiting, and injection site erythema. The incidences of Grade 3-4 adverse reactions were also balanced between the two treatment groups (69% RITUXAN HYCELA vs. 71% RITUXAN). The incidence of serious adverse reactions was 29% for RITUXAN HYCELA and 33% for RITUXAN. The incidence of administration-related reactions in CLL was 44% for RITUXAN HYCELA and 45% for RITUXAN. Of the reported ARRs, local cutaneous reactions with RITUXAN HYCELA were reported in 15 patients. These events resolved within a median of 6 days from the onset (range 3 to 29 days). Majority of these reactions were Grade 1 and 2 and were observed in 14 patients (16%)
- A total of 9 patients (5%) died, including 5 patients in the RITUXAN HYCELA and 4 patients in the RITUXAN group. In the RITUXAN HYCELA group, 1 patient died due to herpes zoster infection, 1 patient died as a result of progressive multifocal leukoencephalopathy (PML) (considered by the investigator as related to rituximab), and 3 patients died due to disease progression. In the RITUXAN group, 2 patients died due to diarrhea and listeriosis, and 2 patients died due to disease progression
