Janssen has revealed multiple pooled data analyses for its Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib) in the first-line treatment for patients with high-risk chronic lymphocytic leukaemia (CLL).
The results, both for the drug as a monotherapy and when combined with other treatments, were presented at the 2020 American Society of Hematology (ASH) Annual Meeting.
Data revealed through an integrated analysis of two Phase 3 trials with 79 months of follow-up showed that rates of progression-free survival (PFS) and overall response (ORR) in patients receiving Imbruvica-based therapy were found to be comparable regardless of the presence of high-risk genomic features int heir disease, including in patients with del(17p)/TP53-mutated/BIRC3-mutated forms.
Furthermore, these benefits were also significant when compared to patients receiving chlorambucil-based therapy, regardless of their genomic risk.
In additional pooled data from four trials with over four years of follow-up, comprising 89 participants whose high-risk CLL demonstrated TP53 aberrations, Imbruvica also displayed “sustained efficacy”, boosting PFS rates and improved poor prognosis.
“These large integrated datasets with follow-up up to six years, in addition to other data presented at the meeting in similar populations, contribute to the accumulating evidence supporting the clinically meaningful, long-term treatment benefit of ibrutinib as first-line therapy for patients with CLL,” commented Dr Craig Tendler, Vice President, Late Development and Global Medical Affairs, Oncology at Janssen Research & Development. “Ibrutinib is an approved standard of care in first-line treatment of CLL, and the data presented at the ASH Annual Meeting further demonstrate the durability of responses in CLL patients with traditional high-risk features.”
Matt Fellows
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