This article is more than 5 years old. Information may no longer be current.
COMFORT: Ruxolitinib improved response rates in myelofibrosis
Click Here to Manage Email Alerts
2011 ASCO Annual Meeting
CHICAGO — Results from the COMFORT II and COMFORT I trials demonstrate that the JAK inhibitor ruxolitinib improved response rates in three forms of myelofibrosis, compared with best available treatment.
“These data suggest that patients with advanced myelofibrosis who are treated with ruxolitinib present with a significant and sustained reduction in the volume of enlarged spleen, with significant and maintained improvement in the overall quality of life, functioning and symptoms,” Alessandro Vannucchi, MD, of the University of Florence, Italy, said during a press conference here. “These effects were clearly different from those that were measured in patients in the best available treatment group who, on the other hand, presented with progressive enlargement of the spleen and worsening of their constitutional symptoms.”
|
|
The phase 3 trial enrolled 219 patients with intermediate or high-risk disease who were randomly assigned to ruxolitinib (n=146) or best available therapy (n=73). The primary endpoint was ≥35% reduction in spleen size, demonstrated by MRI or CT.
The response rate at 24 weeks was 31.9% in the ruxolitinib arm vs. 0% in the best available treatment arm. After 48 weeks, 28.5% of patients assigned to ruxolitinib achieved the primary endpoint, compared with 0% of patients assigned to best available treatment.
According to Vannucchi, the adverse event profile for ruxolitinib was similar to that described in previous studies. Adverse events, including anemia and thrombocytopenia, caused treatment discontinuation in 8.2% of patients in the ruxolitinib arm, compared with 5.5% of patients in the best available treatment arm. One death may have been attributable to ruxolitinib therapy. Vannucchi said that the study was not powered to measure any difference in OS, PFS or leukemia-free survival.
“We are excited in thinking that these data support the idea that ruxolitinib is an important step forward in the treatment of this incurable disorder,” Vannucchi said. “We know that the drug is unable, with the present data we have, to cure the disorder but we know that it can significantly improve overall quality of life for these patients.”
For more information:
- Vannucchi A. #LBA6501. Presented at: 2011 ASCO Annual Meeting; Chicago; June 3-7, 2011.
Disclosure: Dr. Vannucchi reports a consultant or advisory role at Novartis.
 |
Follow HemOncToday.com on Twitter. |