Haematology 2018

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

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

EU: European Union; MCL: mantle cell lymphoma. 1. Wang M et al. N Engl J Med 2013; 369: 507-516