AbbVie announced Friday that its investigational drug navitoclax, when used together with ruxolitinib, eases symptoms in myelofibrosis patients who had not yet been treated with a JAK inhibitor.
Courtesy of AbbVie Inc.
AbbVie announced Friday that its investigational drug navitoclax, when used together with ruxolitinib, eases symptoms in myelofibrosis patients who had not yet been treated with a JAK inhibitor.
The results, presented at the European Hematology Association’s 2022 Hybrid Congress, showed that 63% of evaluable patients experienced a reduction of ≥35% in their spleen volume at 24 weeks, while 41% saw a ≥50% drop in their total symptom score from baseline. At any time during the entire treatment period, 78% and 67% of patients achieved these endpoints, respectively.
Moreover, 35% of evaluable patients demonstrated a ≥1 grade decrease in bone marrow fibrosis (BMF); four patients saw their BMF drop by ≥2 grades. Meanwhile, anemia, a common clinical hallmark of myelofibrosis, improved in 40% of patients after navitoclax treatment.
“Current treatment options for myelofibrosis are limited and targeted toward controlling disease symptoms,” Mohamed Zaki, M.D., Ph.D., vice president and global head of oncology clinical development at AbbVie, said in a statement. “Together with pre-clinical findings, early results of this study demonstrating anti-fibrosis activity of navitoclax in combination with ruxolitinib are promising. Specifically, the data findings regarding reduction in spleen volume, symptoms and bone marrow fibrosis help support the further exploration of disease modification in myelofibrosis.”
These findings come from the company’s Phase II Refine trial, a multi-cohort, randomized, open-label study looking at both the tolerability and efficacy of navitoclax. Data presented at EHA were from an analysis of 32 JAK inhibitor-naïve patients with primary or secondary myelofibrosis and had splenomegaly.
In terms of safety, no new signals of concern were detected, though 97% of patients eventually developed at least one adverse event. Common side effects included thrombocytopenia, anemia and neutropenia. Serious adverse events were also fairly common, arising in almost a quarter of patients. Three participants discontinued navitoclax due to adverse events.
Myelofibrosis is a rare blood cancer that causes the rapid and excessive formation of scar tissue in the bone marrow. Its typical symptoms are fatigue, severe anemia, weakness and an enlarged spleen, which can ultimately debilitate a patient. AbbVie’s navitoclax treats myelofibrosis by targeting the BCL-2 family of proteins, which are known to be regulators of the apoptosis pathway.
AbbVie continued to impress elsewhere at EHA, with data from the Phase III CLL14 trial showing that Venclyxto/Venclexta (venetoclax), when combined with Genentech’s Gazyva (Obinutuzumab), led to better long-term progression-free survival in treatment-naïve chronic lymphocytic leukemia (CLL) patients, as compared with Gazyva plus chlorambucil. No new safety signals arose during the five-year follow-up analysis.
The findings were presented by Genentech, a Roche subsidiary. Venclyxto/Venclexta is being developed by AbbVie in partnership with Roche. In the US, it is being commercialized jointly by AbbVie and Genentech.
“Long-term data from the CLL14 trial show that the one-year fixed-duration combination regimen of venetoclax and obinutuzumab offers patients the possibility of four years of CLL treatment-free response without disease progression,” Zaki said. “Since its approval, this chemotherapy-free combination option has helped transform the therapeutic landscape for CLL.”
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