AbbVie has reported positive data from the Phase II REFINE clinical trial of its investigational therapy navitoclax with ruxolitinib to treat myelofibrosis patients. 

An oral inhibitor of BCL-XL/BCL-2, navitoclax can stimulate programmed cell death (apoptosis) in cancer cells while ruxolitinib is an inhibitor of JAK1/2.

The multicentre, open-label trial has been designed to assess the efficacy and tolerability of navitoclax alone or in combination with ruxolitinib for treating myelofibrosis patients.

The percentage of subjects who attained Spleen Volume Reduction of greater than or equal to 35% (SVR35) from baseline to week 24 was the primary outcome measure of the trial.

Percentage of subjects attaining a 50% decline in Total Symptom Score from baseline to week 24 and variation in grade of bone marrow fibrosis as evaluated on the European Consensus Grading System were included as the secondary outcomes measures.

According to data from an exploratory analysis of 34 subjects, 38% of them, evaluable for bone marrow fibrosis (BMF) improvements, had a ≥1 grade improvement at any time point in the trial.

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By GlobalData

For driver gene variant allele frequency (VAF) decline, 26 subjects were evaluable and 23% attained a ≥20% decline at week 24. 

In the trial, five subjects attained both BMF and VAF responses. 

Anti-fibrosis activity evaluated by reversal of BMF and decline in driver gene VAF are recommended as potential biomarkers to assess disease modification in myelofibrosis.

Furthermore, median overall survival (OS) for all subjects was not attained while 100% of the subjects had a minimum of one adverse event (AE).

Thrombocytopenia, diarrhoea, fatigue and nausea were observed to be the most common AEs of any grade.

AbbVie oncology clinical development vice-president and global head Mohamed Zaki said: “Disease control with reversal of bone marrow fibrosis is a key objective for improving patient outcomes. 

“That’s why we are especially pleased about these early results of navitoclax in combination with ruxolitinib that indicate its novel mechanism of action of inducing cell death may cause reversal of bone marrow fibrosis and extend survival for patients who respond to treatment.”

A rare blood cancer, myelofibrosis leads to excessive scar tissue formation or fibrosis in the bone marrow. 

In November 2021, the company reported findings from a post-hoc analysis of the Phase III SELECT-BEYOND trial of Rinvoq (upadacitinib) in rheumatoid arthritis patients.