A supplemental New Drug Application (sNDA) for IMBRUVICA® (ibrutinib) has been submitted to the FDA for front-line use in patients with chronic lymphocytic leukemia (CLL), Janssen Biotech Inc. has announced. The filing is based on data from the randomized, multi-center, open-label Phase 3 RESONATE™-2 (PCYC-1115) trial assessing the use of ibrutinib versus chlorambucil in patients with treatment-naive CLL or small lymphocytic lymphoma (SLL) aged 65 years or older. IMBRUVICA is jointly developed and commercialized by Janssen and Pharmacyclics LLC, an AbbVie company. Pharmacyclics is the investigational new drug (IND) holder for IMBRUVICA in the U.S. and submitted the application to the FDA on behalf of the companies.
"Treatment-naive patients with this disease typically relapse or become refractory to standard chemotherapy, so new options are greatly needed to potentially change the CLL/SLL treatment paradigm," said Jan Burger, M.D., Ph.D., Associate Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX and study lead investigator.
The RESONATE-2 trial enrolled 269 patients with treatment-naive CLL/SLL aged 65 years or older in the U.S., EU and other regions. Patients were randomized to receive either ibrutinib 420 mg orally, once daily until progression or toxicity or chlorambucil 0.5 to 0.8 mg/kg on days 1 and 15 of each 28-day cycle for up to 12 cycles. At the time of the final analysis, the primary endpoint was met, with ibrutinib shown to be superior to chlorambucil in terms of progression-free survival (PFS). In addition, ibrutinib demonstrated significant improvements in key secondary efficacy endpoints, including overall survival (OS), overall response rate (ORR) and in hematologic function.
"This submission to expand the use of IMBRUVICA for patients with treatment-naive CLL is very significant, as this patient population represents the largest group of patients with CLL," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen Research & Development, LLC. "The submission highlights our commitment to developing medicines that truly transform treatment paradigms and patient outcomes, as well as our commitment to further develop IMBRUVICA in hematologic malignancies."
The RESONATE-2 trial was sponsored by Pharmacyclics. The data have been submitted for presentation at an upcoming medical conference and for publication in a peer-reviewed journal. More information about the study can be found on www.clinicaltrials.gov.
Janssen Research & Development, LLC and Pharmacyclics are continuing an extensive clinical development program for IMBRUVICA, including Phase 3 study commitments in multiple patient populations.