Long-term data from pivotal Phase III studies of ibrutinib presented at ASCO and EHA

Janssen has announced long-term follow-up results from two pivotal Phase III studies of Imbruvica^® (ibrutinib) in patients with chronic lymphocytic leukaemia (CLL), a type of non-Hodgkin lymphoma and the most common form of leukaemia in adults.¹ 

 

One set of data – results from the RESONATE^TM study (PCYC-1112) at a median follow-up of 65.3 months (range, 0.3–71.6) – showed treatment with ibrutinib monotherapy sustained progression-free survival (PFS) benefit compared to ofatumumab in patients with previously treated CLL, with a median PFS of 44.1 months versus 8.1 months, respectively.²

 

A consistent PFS benefit with ibrutinib  was  observed  across  all  baseline  disease  and  patient  characteristics,  including patients with genomically defined high-risk disease.1 The median overall survival (OS) was 67.7 months in the ibrutinib arm and 65.1 months in the ofatumumab arm, without censoring or adjustment for crossover from ofatumumab to ibrutinib.² Additionally, no new safety events were identified in this long-term follow-up.1 The RESONATE^TM results were presented at the 55th American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, and selected for the Best of ASCO 2019 Meetings, which highlight cutting-edge science and reflect leading research in oncology (abstract #7510). 

 

The second data set – results from the RESONATE^TM-2 study (PCYC-1115/1116) at a median follow-up of five years (range, 0.1–66 months) – demonstrated durable PFS with ibrutinib monotherapy  (estimate of 70%)  versus chlorambucil (estimate of 12%) in patients with previously untreated CLL, including those with genomically defined high-risk disease.²

 

The OS benefit was also sustained in patients treated with ibrutinib (estimate of 83%) versus chlorambucil (estimate of 68%). In addition, no new safety concerns were observed.3The RESONATE^TM-2 data will be presented in full during an oral presentation at the 24th European Hematology Association (EHA) Congress in Amsterdam on Friday, June 14 (abstract #S107).³

 

“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 Peter Hillmen, MB ChB, PhD, Professor of Experimental Haematology and Honorary Consultant Haematologist at Leeds Teaching Hospitals NHS Trust, United Kingdom and 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.”

 

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