Combined data from phase III studies of Imbruvica shows efficacy and safety in high-risk, previously untreated chronic lymphocytic leukemia and real-world data indicating low biomarker testing rates . AbbVie.

AbbVie announced results from a long-term integrated analysis of two Phase III clinical studies and additional pooled analysis evaluating the effect of Imbruvica (ibrutinib) based therapies for the first-line treatment of high-risk patients with chronic lymphocytic leukemia (CLL)b> The totality of data featured at the virtual 2020 American Society of Hematology (ASH) Annual Meeting continues to establish the treatment benefit of Imbruvica for CLL patients with or without high-risk disease. Results from an integrated analysis of two Phase III clinical trials (RESONATE-2 and iLLUMINATE) with up to 6.5 years of long-term follow-up investigating the use of Imbruvica-based therapies in patients with CLL/small lymphocytic lymphoma (SLL) with first-line treatment showed similar progression-free survival (PFS) and overall response rates (ORR) in patients with or without high-risk genomic features (Abstract #2220).Additionally, a pooled analysis across four clinical trials with up to 8 years of follow-up, including three Phase III studies (RESONATE-2, iLLUMINATE, E1912), and the Phase II PCYC-1122e study - sponsored by the National Heart, Lung, and Blood Institute (NHLBI)- showed that first-line treatment with Imbruvica-based therapies resulted in sustained, long-term efficacy with high 4-year PFS rates in high-risk CLL patients, defined as del(17p) or TP53 gene mutations (Abstract 2219). "The presence of del(17p) or TP53 gene mutation is a strong negative predictor of survival in patients with CLL, and testing for these markers is important so patients receive optimal therapy," said John Allan, M.D., assistant professor of medicine in the Division of Hematology and Medical Oncology and a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and principal study investigator of the pooled analysis. "Although these patients remain at risk for disease progression, first-line treatment with ibrutinib based therapy may meaningfully improve the poor prognosis in this high-risk population." The informCLL real-world prospective observational registry assessing treatment patterns was featured in an oral presentation. Data from this real-world evidence study showed low testing rates for prognostic and biomarker features among patients with CLL. Further, when biomarker testing was performed, the selection of chemo-immunotherapy (CIT) continued for a considerable proportion of patients with del(17p)/TP53 mutational status, which is inconsistent with current guidelines (Abstract 547). As well, a retrospective, chart review study of real world patients featured as an oral presentation examined treatment patterns and time to next treatment (TTNT) in patients with CLL. Results showed high-risk patients with CLL treated with Imbruvica monotherapy had longer TTNT than those treated with CIT, and that Imbruvica therapy showed similar results in high risk and non-high-risk patients (Abstract 372).