Results from a 48-month follow-up analysis of the Phase 3 E1912 clinical study reported a statistically significant difference in PFS and OS for IMBRUVICA plus rituximab compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR). Further, the latest integrated analysis from the Phase 3 RESONATE (PCYC-1112) and RESONATE-2 (PCYC-1115/1116) studies investigating the use of single-agent IMBRUVICA in CLL, reported that at up to six years of follow-up, PFS, OS and response rates improved when IMBRUVICA was used in earlier lines of therapy. During this extended follow-up, IMBRUVICA was tolerated across all lines of therapy with 19 percent of patients discontinuing due to adverse events.
In addition, results presented from the Phase 2 CAPTIVATE study suggest that patients who received IMBRUVICA plus venetoclax as a time-limited treatment achieved high rates of uMRD in peripheral blood (75 percent of patients) and bone marrow (72 percent of patients).
These new findings from the E1912, RESONATE/RESONATE-2 and CAPTIVATE studies were presented at the 2019
'We're pleased to see follow-up results from the Phase 3 E1912 trial, where the investigational use of IMBRUVICA plus rituximab is shown to extend OS for previously untreated patients with CLL. In addition, with the integrated analysis of the Phase 3 RESONATE and RESONATE-2 studies, IMBRUVICA demonstrated an OS benefit in untreated and relapsed patients with improved outcomes in early lines of therapy,' said
E1912 extended follow-up of investigational use of IMBRUVICA plus rituximab compared to FCR in patients with CLL/SLL ages 70 or younger (Abstract #33)
Longer-term outcomes data from the Phase 3 E1912 clinical trial - designed and conducted by the
At a median follow-up of 48 months, 73 percent of patients in the IMBRUVICA plus rituximab treatment arm remained on IMBRUVICA with median time on treatment of 43 months. PFS benefits were observed for the IMBRUVICA plus rituximab arm as compared to the FCR treatment arm (hazard ratio [HR], 0.39; 95 percent confidence interval [CI], 0.26-0.57; p
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