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Phase II trial

Study design

Ibrutinib monotherapy was

studied in MCL patients

(N=111) with a range of

exposure to prior treatments

in an open-label, multicentre,

international, phase II trial.

1†

72% of patients had

advanced disease

45% of patients had

refractory disease

55% of patients had

received 3 or more prior

regimens

EU: European Union; MCL: mantle cell lymphoma.

1. Wang M et al. N Engl J Med 2013; 369: 507-516

Design of a phase II MCL study (PCYC-1104)

1

* 63/111 patients had received treatment with bortezomib* (≥2 cycles) and 48/111 had not reached such treatment

(<2 complete cycles or no prior therapy)

Refractory disease was defined as a lack of at least a partial response to the last therapy before study entry. Advanced

disease was defined as involvement of bone marrow, extranodal sites or both

1

*Bortezomib is not approved for use in the treatment of MCL within the EU