Janssen reports positive Phase ll and lll data of imbruvica

13th December 2017 (Last Updated December 13th, 2017 00:00)

Janssen-Cilag International has reported positive results from a pooled analysis that includes Phase ll and lll studies of imbruvica (ibrutinib) in patients with relapsed/refractory (r/r) mantle cell lymphoma (MCL).

Janssen-Cilag International has reported positive results from a pooled analysis that includes Phase ll and lll studies of imbruvica (ibrutinib) in patients with relapsed/refractory (r/r) mantle cell lymphoma (MCL).

The analysis also includes extended follow-up data of 87 patients enrolled across the two studies.

The data also demonstrated that patients treated with imbruvica earlier or at first relapse experienced improved clinical results in terms of both efficacy and tolerability.

As part of the long-term open-label extension study, 83 of the total subjects were treated with ibrutinib for three or more years, while 40 patients were treated with ibrutinib for four or more years.

After following them up for 3.5 years, the overall median progression-free survival (PFS) was 13 months and 33.6 months in patients with one prior line of therapy.

The median PFS in patients who achieved complete response (CR) was 46.2 months and the duration of response in these patients was 55.7 months.

"New onset adverse events decrease over time and are generally less common when patients are treated earlier."

Results also found that the patients with favourable baseline disease characteristics were more likely to remain on ibrutinib for more than three years.

In addition, 53%, 45% and 37% of patients were alive at two, three, and five years respectively, and the median overall survival (OS) was 26.7 months.

Plymouth University Medical School Haematology professor and the pooled analysis lead investigator Simon Rule said: “Data from this large clinical trial dataset with extended follow-up support the early use of ibrutinib in patients with relapsed or refractory mantle cell lymphoma.

“Long-term follow-up for ibrutinib demonstrates, that in addition to efficacy, new onset adverse events decrease over time and are generally less common when patients are treated earlier.”

Ibrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor, which is designed to work by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.