AbbVie Inc. / Infinity Pharmaceuticals, Inc.

Chronic Lymphocytic Leukemia (CLL) and Indolent Non-Hodgkin Lymphoma (iNHL)

21K US cases/yr

Disease Overview

CLL is the most common adult leukemia in the US, characterized by clonal proliferation of mature B-lymphocytes. Indolent non-Hodgkin lymphomas (including follicular lymphoma and small lymphocytic lymphoma) share an overlapping biology and treatment landscape. While many patients have indolent courses, relapsed/refractory disease remains difficult to treat and drives demand for novel targeted agents.

Competitive Landscape

Duvelisib (IPI-145) entered AbbVie's portfolio in September 2014 amid rapid evolution of the B-cell malignancy treatment paradigm. The dominant disruptor was Imbruvica (ibrutinib), the BTK inhibitor jointly commercialized by Pharmacyclics/Janssen, which gained FDA approval for CLL in February 2014 and went on to define the front-line standard. Gilead's Zydelig (idelalisib), a PI3K-delta inhibitor, was approved July 2014 for relapsed CLL/follicular lymphoma but later restricted due to fatal infections and hepatotoxicity. The emergence of venetoclax (Venclexta, AbbVie/Genentech) as a BCL-2 inhibitor and the subsequent acalabrutinib (Calquence, AstraZeneca, approved 2019) further compressed the opportunity for late-entry oral agents. Duvelisib's dual PI3K-delta/gamma profile was differentiated theoretically, but AbbVie returned rights in 2016 after Phase 2 iNHL data underwhelmed. Verastem licensed the asset for ~$28M total milestones, secured FDA approval as Copiktra in September 2018, and ultimately sold rights to Secura Bio in 2020 for $70M plus milestones. The FL indication was withdrawn in April 2022.