Safety
“Navitoclax in combination with ruxolitinib appears to be well tolerated,” Dr. Garcia said.
She noted that treatment resulted in reduced platelet counts, but counts stabilized after 6-8 weeks. The mean platelet count was 232 x 109/L at baseline and 95 x 109/L at week 8.
In fact, the most common adverse event was thrombocytopenia, with any-grade thrombocytopenia occurring in 85% of patients and grade 3/4 occurring in 44%. One patient had grade 4 thrombocytopenia, but it was reversed by withholding treatment and subsequent dose modification.
Other common treatment-emergent adverse events were diarrhea (68%), fatigue (53%), nausea (35%), anemia (29%), dizziness (27%), confusion (27%), and vomiting (24%).
All 34 patients experienced at least one adverse event. Eight patients (24%) had serious adverse events, including anemia, pancytopenia, splenic infarction, upper abdominal pain, vomiting, chest pain, pneumonia, and abnormal liver function test.
One patient had a grade 5 adverse event – pneumonia – that was deemed unrelated to navitoclax.
This trial is sponsored by AbbVie. Dr. Garcia reported relationships with AbbVie, Genentech, and Pfizer.
SOURCE: Garcia JS et al. ASH 2019, Abstract 671.