MDS: Canakinumab Phase 1b/2 Study


A hematologist/oncologist discusses a phase 1b/2 study investigating canakinumab in patients with myelodysplastic syndrome.

This is a video synopsis of a discussion featuring Gary J. Schiller, MD, chief of the Hematological Malignancy/Stem Cell Transplantation program at the David Geffen School of Medicine at UCLA Health Jonsson Comprehensive Cancer Center.

In this phase 1/2 trial, Dr Sallman and colleagues from Tampa and Atlanta examined the anti-inflammatory drug canakinumab in patients with IPSS-R very low to intermediate risk MDS. Patients had erythropoiesis-stimulating agent (ESA) refractory, transfusion-dependent anemia or symptomatic hemoglobin <9 g/dL and were hypomethylating agent naive.

Canakinumab targets the inflammasome and was given on day 1 of 28-day cycles at doses of 150 mg and 300 mg, along with darbepoetin on days 1 and 15. Patients received up to 6 cycles. The phase Ib primary purpose was determining maximum tolerated dose. Bone marrow cytomorphology and disease assessments occurred every 3 months.

Nine elderly (median age 70 years) patients were reported, mostly female with low-risk IPSS but high-risk mutations including SF3B1, ASXL1, ZRSR2, TET2, and U2AF1. The canakinumab and darbepoetin combination was safe and well tolerated. A marked reduction in the inflammatory biomarker IL-18 was observed. However, no clinical responses were seen yet in this small phase 1b cohort.

A phase II trial is pending, focusing on lower transfusion burden patients with increased baseline inflammation. This will better determine if targeting inflammation with canakinumab improves erythroid response and quality of life in MDS.

*Video synopsis is AI-generated and reviewed by Targeted Oncology editorial staff.

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