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Interview with Dr. Peter Hillmen - EHA 2014
Leeds Teaching Hospital NHS Trust
Interview with Dr. Peter Hillmen, consultant hematologist at the Leeds Teaching Hospital NHS Trust.
Dr. Hillmen has presented impressing results of a Phase III trial with ibrutinib in relapsed or refractory patients with chronic lymphoid leukemia (CLL) or small lymphocytic lymphoma (SLL) (see report via this link). The data showed that ibrutinib significantly improved progression free survival (PFS), overall survival, and response rate compared to ofatumumab in previously treated CLL/SLL, validating ibrutinib as an effective new single agent therapy for CLL/SLL patients.
Ibrutinib seems to be a game-changer for CLL. Previous studies already showed impressive results and this Phase III extends on that, showing superiority compared to the best licensed drug currently available. It is showing results not previously seen with other drugs. Also, the adverse event profile is good. It is an oral agent and adverse events are scarce and mild – only one out of 108 patients stopped because of the adverse events. Also, after the study, 86% of patients are remaining on this treatment.
Trial details: it is a first randomized phase III trial in CLL that included 391 patients that failed chemotherapy or were not fit for chemotherapy or had resistant disease with a 70p deletion. Patients were randomized, half on ofatumumab (a monoclonal antibody for the CD20 protein; approved for CLL) and half on oral ibrutinib. Endpoints were PFS, overall survival, and safety. The trial showed clear differences in all those endpoints. PFS for ofatumumab was a median of 8 months, whereas almost all patients on ibrutinib survived the entire 12 months trial period, of which 60% was progression free – and 86% of the patients remained on ibrutinib. In the follow-up, 57% less patients died in the ibrutinib arm than in the ofatumumab arm. Responses were much higher with ibrutinib and the drug was very well tolerated.
Approval of ibrutinib in Europe?
Question: what is it going to take to get this drug approved in Europe? Previous trials were already impressive, and have been submitted in Europe. The current data clearly proofs efficacy and will be sufficient for approval both in the US as in Europe. And that will be a building block for designing even better regimes for treating CLL.
Future of ibrutinib as primary therapy
Question: does the drug have a future as primary therapy? Yes. Obviously for the patients included in this trial (unfit for chemotherapy), but phase II trials are ongoing with also more fit patients and preliminary results are very promising, showing PFS of over 2 years. A UK study in younger, fitter patients has just started, comparing the drug against the frontline treatment, in an effort to take chemotherapy out of the treatment equation.
Good news was needed in this area, and with this novel drug, and several others in the pipeline that target the same and different pathways, we are looking at a future where we can combine different drugs, further raising efficacy and potentially a chemotherapy-free treatment of CLL.