ORLANDO, Fla. and HORSHAM, Pa., Dec. 7, 2015 /PRNewswire/ -- Results from a sub-analysis of the Phase 2 RESONATE-17 (PCYC-1117) study showed IMBRUVICA® (ibrutinib) was associated with robust efficacy and a positive risk-benefit profile in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have the genetic alteration del 17p. Notably, IMBRUVICA was associated with a high overall response rate (Independent Review Committee [IRC]-assessed ORR; the primary endpoint) and long progression-free survival (PFS) across a variety of baseline genetic characteristics or mutations. These data will be presented in an oral session today at the 2015 American Society of Hematology (ASH) meeting in Orlando, FL. IMBRUVICA is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.
These results will be presented in full by RESONATE-17 study investigator Stephan Stilgenbauer, M.D., Associate Professor, Department of Hematology, Oncology, Rheumatology and Infectious Diseases at the University of Ulm, Germany, during the “CLL: Therapy, excluding Transplantation: Relapsed/Refractory CLL Therapy Excluding Transplantation” session on Monday, December 7 at 5:30 p.m. ET. This sub-analysis was compiled from RESONATE-17 results first presented last year at the ASH 2014 annual meeting. IMBRUVICA was approved by the U.S. Food and Drug Administration (FDA) in July 2014 to treat patients with del 17p CLL.
“CLL patients with the genetic alteration del 17p are considered to be high risk and typically have poor prognoses,” said Dr. Stilgenbauer. “IMBRUVICA was the first therapy approved specifically for this difficult-to-treat patient population and the positive data seen in this analysis reinforce its clinical utility in CLL patients with del 17p.”
RESONATE-17 is one of the largest dedicated studies conducted in patients with relapsed or refractory CLL with del 17p. The study evaluated 144 previously treated patients with del 17p (137 with CLL, seven with SLL), who received single-agent IMBRUVICA once daily until progression or unacceptable toxicity. A total of 116 patients were determined to have baseline genetic characteristics with the potential to influence treatment outcomes. The primary endpoint of the open-label, single-arm, multi-center trial was ORR, as measured by the IRC. Duration of response (DOR), PFS and safety were key secondary endpoints. At the time of the data assessment, the median treatment duration was 11.1 months and 70 percent of people continued treatment with IMBRUVICA.
After a median follow-up of 11.5 months, the investigator-assessed ORR including partial response with lymphocytosis (PR-L) for all treated patients was 83 percent in the RESONATE-17 trial; specifically, 17 percent of patients experienced a PR-L. While median PFS and OS were not yet reached, the 12-month PFS and OS rates were 79 and 84 percent, respectively. Overall, results were consistent across subgroups with additional baseline characteristics or mutations (e.g., del 11q, del 13q, NOTCH1, TP53, etc.).
“IMBRUVICA was the first therapy to be approved by the FDA specifically for CLL patients with the del 17p genetic alteration. The RESONATE-17 trial is one of the largest prospective trials ever conducted solely in this patient population, whose outcome is usually quite poor when treated with available therapies,” said Craig Tendler, M.D., Vice President, Late-Stage Development and Global Medical Affairs for Oncology, Janssen Research & Development. “As we look deeper into the role of IMBRUVICA for the treatment of patients with CLL, we are very encouraged by the durable remissions and well tolerated safety profile achieved with IMBRUVICA in patients with del 17p CLL, in spite of the poor prognosis associated with this genetic alteration.”
The most common adverse events (AEs =20 percent) of any Grade included diarrhea (36 percent), fatigue (31 percent), cough (24 percent) and arthralgia (22 percent). Serious AEs (SAEs) occurred in 40 percent of patients; 38 percent of all SAEs were Grade 3 or greater.
About IMBRUVICA® (ibrutinib)
IMBRUVICA was one of the first therapies to receive U.S. approval after having received the FDA’s Breakthrough Therapy Designation. IMBRUVICA works by blocking a specific protein called Bruton’s tyrosine kinase (BTK).1 The BTK protein transmits important signals that tell B cells to mature and produce antibodies and is needed by specific cancer cells to multiply and spread.1,2 IMBRUVICA targets and blocks BTK, inhibiting cancer cell survival and spread.1 For more information, visit www.IMBRUVICA.com.
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