Janssen’s Imbruvica shows superiority in Phase 3 trials
pharmafile | June 4, 2019 | News story | Manufacturing and Production | Janssen, imbruvia, leukaemia, pharma, phase 3, trial
Phase 3 data from ASCO 2019 has shown Janssen’s leukaemia drug Imbruvica (ibrutinib) had significant benefits over ofatumumab.
In the Phase 3 RESONATE trial Imbruvica sustained progression free survival (PFS) for 44.1 months in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) compared to ofatumumab which sustained survival for 8.1 months.
A second set of data from the RESONATE-2 trial showed imbruvica’s superiority over chlorambucil in patients with previously untreated CLL.
“Since its first European approval in 2014, ibrutinib has redefined treatment paradigms for CLL, and these study results offer further evidence to both clinicians and patients of the longer-term benefits and tolerability ibrutinib offers as a single agent,” said Dr Peter Hillmen, Professor of Experimental Haematology and Honorary Consultant Haematologist at Leeds Teaching Hospitals NHS Trust, investigator in both studies.
“Not only is superior progression-free survival and overall survival maintained with ibrutinib follow-up, but frequently the quality of response rates improves from partial to complete over time.”
“Ibrutinib has already impacted more than 140,000 patients, and the RESONATE and RESONATE-2 long-term follow-up studies provide important data in support of its continued use in the effective management of CLL,” said Dr Patrick Laroche, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen-Cilag France.
“We are excited to explore how best this BTK inhibitor can continue to enhance the lives of people living with CLL, both as a monotherapy and in newer combination regimens, and as an alternative option to intensive chemotherapy.”
Louis Goss
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