Results from an open-label phase 2a study of cerdulatinib, a dual spleen tyrosine kinase/janus kinase inhibitor, in relapsed/refractory peripheral T-cell lymphoma

Abstract

In this phase-2a study (NCT01994382), patients aged ≥18 years with relapsed/refractory peripheral T-cell lymphoma (PTCL; angioimmunoblastic T-cell lymphoma/T follicular helper [AITL/TFH], n = 29); PTCL-not otherwise specified [NOS], n = 11; and Other, n = 25) received 30 mg oral cerdulatinib, a reversible dual inhibitor of spleen tyrosine kinase and Janus kinase, twice daily in 28-day cycles until disease progression or unacceptable toxicity. Overall response rate (ORR) was 36.2% (12 complete responses [CR],9 partial responses [PR], and 14 stable disease); median time to response was 1.9 months. ORR was 51.9% for AITL/TFH (10 CR, 4 PR) and 31.8% for Other (2 CR, 5 PR); median duration of response was 12.9 and 5.3 months, respectively. The most common grade ≥3 treatment-emergent adverse events were asymptomatic amylase elevation (23.1%), anemia (20.0%), and asymptomatic lipase elevation (18.5%). These data suggest clinical activity and acceptable tolerability for cerdulatinib in patients with relapsed/refractory PTCL.

Keywords: Peripheral T-cell lymphoma; dual spleen tyrosine kinase/janus kinase inhibitor; phase-2 study; relapsed/refractory.