AbbVie announced positive data from Phase 2 leukemia combo study

AbbVie announced positive data from the Phase 2 CAPTIVATE study evaluating IMBRUVICA, or ibrutinib, in combination with VENCLEXTA in previously-untreated chronic lymphocytic leukemia/small lymphocytic lymphoma patients. Early results of the combination oral regimen suggest promising activity in treatment-naive CLL/SLL with 77% of the first 30 patients achieving responses with no detectable minimal residual disease after six cycles of the combination therapy. MRD is determined by measuring the number of cancer cells remaining and helps confirm depth of remission. The first 14 CLL/SLL patients to complete the clinical trial combination therapy of 12 cycles achieved responses with no detectable MRD in approximately nine out of 10 patients, with 93% achieving MRD negativity when measuring in peripheral blood and 86 percent with MRD negativity when measuring in the bone marrow. The most common AEs were diarrhea, fatigue, nausea, headache, upper respiratory tract infection and arthralgia. Grade 3 or higher AEs – occurring in greater than or equal to 3% patients – were neutropenia, hypertension, diarrhea and thrombocytopenia. No clinical tumor lysis syndrome occurred and lab TLS was seen in 1 of 164 patients. In treated patients with baseline LDi 5 cm or greater, LDi decreased to less than 5 cm in 43 of 53 patients after ibrutinib lead-in. TLS risk shifted from high to medium/low in 36 of 40 patients, and overall, the proportion of high-risk TLS decreased from 24% at baseline to 3% after ibrutinib lead-in.

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