ORLANDO - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced combination data from two studies and a long-term integrated analysis evaluating the use of IMBRUVICA (ibrutinib) for the treatment of previously untreated patients with CLL or small lymphocytic lymphoma (SLL).

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 American Society of Hematology (ASH) Annual Meeting.

'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 Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. 'We are also excited to see the first MRD data from the fixed-duration regimen of IMBRUVICA plus venetoclax in the Phase 2 CAPTIVATE trial, reporting a high rate of undetectable MRD at 15 months both in the peripheral blood and bone marrow.'

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 ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health - were also presented. As previously reported in earlier data readouts, the study evaluated 354 previously untreated patients with CLL ages 70 years or younger who were randomly assigned to receive IMBRUVICA and rituximab or six courses of intravenous FCR every 28 days.

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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