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ASH Annual Meeting
Photo courtesy of ASH
ORLANDO, FL—Five-year results from the COMFORT-II trial appear to confirm that treatment with ruxolitinib can improve spleen size and survival in patients with myelofibrosis (MF).
“These results pave the way to use ruxolitinib earlier in the course of the disease,” said lead study author Claire Harrison, MD, a consultant hematologist at Guy’s and St. Thomas’ NHS Foundation Trust in London, UK.
Dr Harrison presented the results at the 2015 ASH Annual Meeting (abstract 59).
Ruxolitinib, a JAK1/JAK2 inhibitor, has demonstrated rapid, durable improvements in splenomegaly and MF symptoms, as well as improved survival in the phase 3 COMFORT-I and COMFORT-II studies.
In COMFORT-II, significantly more patients achieved the primary endpoint—a 35% or greater decrease in spleen volume from baseline at week 48—with ruxolitinib than with best available therapy (BAT).
The 3-year follow-up confirmed that spleen volume reductions were sustained, and ruxolitinib treatment remained tolerable with long-term use.
The randomized, open-label, multicenter study included 219 patients with primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF.
Two-thirds of patients received ruxolitinib twice daily, and one-third of patients received BAT, which was administered at doses and schedules determined by the investigator.
Almost two-thirds of the patients on the BAT arm crossed over to receive ruxolitinib upon protocol-defined progression following the primary analysis after week 48. All patients randomized to BAT have crossed over or discontinued, Dr Harrison said.
She presented the 5-year final study results, which showed that more than half of the patients (53.4%) experienced significant reductions in spleen size with ruxolitinib therapy and sustained this benefit over a median duration of 3.2 years.
“There was a 33% improvement in overall survival with ruxolitinib as compared to BAT,” she said.
Using a statistical model of survival if patients had not crossed-over to ruxolitinib, the survival benefit was 56% in favor of ruxolitinib.
“The plateau in spleen responses correlates well with the survival advantage,” Dr Harrison said.
She noted that the JAK allele burden was also reduced in the majority of patients who crossed over during the study. A recent bone marrow analysis shows a 20% improvement in fibrosis as well.
Nearly one-quarter of patients from both the ruxolitinib arm and those who crossed over from the BAT arm remained on treatment with ruxolitinib for 5 years.
All adverse events were consistent with previous analyses of treatment with ruxolitinib in MF, Dr Harrison said. The most common adverse events in ruxolitinib-treated patients were thrombocytopenia (52.4%), anemia (49.2%), diarrhea (35.6%), and peripheral edema (33%).
The most common grade 3/4 adverse events included anemia (22.5%), thrombocytopenia (15.2%), pneumonia (5.8%), general physical health deterioration (4.2%), and shortness of breath (4.2%).
“This long-term analysis after a vast number of patient-years shows the ongoing benefit, with no new safety signals and a strong survival message,” Dr Harrison said.
“Hematologists can be confident treating patients with ruxolitinib. It is safe, effective, and leads to significant long-term benefit. Myelofibrosis patients feel better, their spleens are smaller, and they may survive longer.”
COMFORT-II was sponsored by Novartis, which licensed ruxolitinib from Incyte Corporation for development and commercialization outside the US. COMFORT-I was sponsored by Incyte. 
ASH Annual Meeting
Photo courtesy of ASH
ORLANDO, FL—Five-year results from the COMFORT-II trial appear to confirm that treatment with ruxolitinib can improve spleen size and survival in patients with myelofibrosis (MF).
“These results pave the way to use ruxolitinib earlier in the course of the disease,” said lead study author Claire Harrison, MD, a consultant hematologist at Guy’s and St. Thomas’ NHS Foundation Trust in London, UK.
Dr Harrison presented the results at the 2015 ASH Annual Meeting (abstract 59).
Ruxolitinib, a JAK1/JAK2 inhibitor, has demonstrated rapid, durable improvements in splenomegaly and MF symptoms, as well as improved survival in the phase 3 COMFORT-I and COMFORT-II studies.
In COMFORT-II, significantly more patients achieved the primary endpoint—a 35% or greater decrease in spleen volume from baseline at week 48—with ruxolitinib than with best available therapy (BAT).
The 3-year follow-up confirmed that spleen volume reductions were sustained, and ruxolitinib treatment remained tolerable with long-term use.
The randomized, open-label, multicenter study included 219 patients with primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF.
Two-thirds of patients received ruxolitinib twice daily, and one-third of patients received BAT, which was administered at doses and schedules determined by the investigator.
Almost two-thirds of the patients on the BAT arm crossed over to receive ruxolitinib upon protocol-defined progression following the primary analysis after week 48. All patients randomized to BAT have crossed over or discontinued, Dr Harrison said.
She presented the 5-year final study results, which showed that more than half of the patients (53.4%) experienced significant reductions in spleen size with ruxolitinib therapy and sustained this benefit over a median duration of 3.2 years.
“There was a 33% improvement in overall survival with ruxolitinib as compared to BAT,” she said.
Using a statistical model of survival if patients had not crossed-over to ruxolitinib, the survival benefit was 56% in favor of ruxolitinib.
“The plateau in spleen responses correlates well with the survival advantage,” Dr Harrison said.
She noted that the JAK allele burden was also reduced in the majority of patients who crossed over during the study. A recent bone marrow analysis shows a 20% improvement in fibrosis as well.
Nearly one-quarter of patients from both the ruxolitinib arm and those who crossed over from the BAT arm remained on treatment with ruxolitinib for 5 years.
All adverse events were consistent with previous analyses of treatment with ruxolitinib in MF, Dr Harrison said. The most common adverse events in ruxolitinib-treated patients were thrombocytopenia (52.4%), anemia (49.2%), diarrhea (35.6%), and peripheral edema (33%).
The most common grade 3/4 adverse events included anemia (22.5%), thrombocytopenia (15.2%), pneumonia (5.8%), general physical health deterioration (4.2%), and shortness of breath (4.2%).
“This long-term analysis after a vast number of patient-years shows the ongoing benefit, with no new safety signals and a strong survival message,” Dr Harrison said.
“Hematologists can be confident treating patients with ruxolitinib. It is safe, effective, and leads to significant long-term benefit. Myelofibrosis patients feel better, their spleens are smaller, and they may survive longer.”
COMFORT-II was sponsored by Novartis, which licensed ruxolitinib from Incyte Corporation for development and commercialization outside the US. COMFORT-I was sponsored by Incyte.
ASH Annual Meeting
Photo courtesy of ASH
ORLANDO, FL—Five-year results from the COMFORT-II trial appear to confirm that treatment with ruxolitinib can improve spleen size and survival in patients with myelofibrosis (MF).
“These results pave the way to use ruxolitinib earlier in the course of the disease,” said lead study author Claire Harrison, MD, a consultant hematologist at Guy’s and St. Thomas’ NHS Foundation Trust in London, UK.
Dr Harrison presented the results at the 2015 ASH Annual Meeting (abstract 59).
Ruxolitinib, a JAK1/JAK2 inhibitor, has demonstrated rapid, durable improvements in splenomegaly and MF symptoms, as well as improved survival in the phase 3 COMFORT-I and COMFORT-II studies.
In COMFORT-II, significantly more patients achieved the primary endpoint—a 35% or greater decrease in spleen volume from baseline at week 48—with ruxolitinib than with best available therapy (BAT).
The 3-year follow-up confirmed that spleen volume reductions were sustained, and ruxolitinib treatment remained tolerable with long-term use.
The randomized, open-label, multicenter study included 219 patients with primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF.
Two-thirds of patients received ruxolitinib twice daily, and one-third of patients received BAT, which was administered at doses and schedules determined by the investigator.
Almost two-thirds of the patients on the BAT arm crossed over to receive ruxolitinib upon protocol-defined progression following the primary analysis after week 48. All patients randomized to BAT have crossed over or discontinued, Dr Harrison said.
She presented the 5-year final study results, which showed that more than half of the patients (53.4%) experienced significant reductions in spleen size with ruxolitinib therapy and sustained this benefit over a median duration of 3.2 years.
“There was a 33% improvement in overall survival with ruxolitinib as compared to BAT,” she said.
Using a statistical model of survival if patients had not crossed-over to ruxolitinib, the survival benefit was 56% in favor of ruxolitinib.
“The plateau in spleen responses correlates well with the survival advantage,” Dr Harrison said.
She noted that the JAK allele burden was also reduced in the majority of patients who crossed over during the study. A recent bone marrow analysis shows a 20% improvement in fibrosis as well.
Nearly one-quarter of patients from both the ruxolitinib arm and those who crossed over from the BAT arm remained on treatment with ruxolitinib for 5 years.
All adverse events were consistent with previous analyses of treatment with ruxolitinib in MF, Dr Harrison said. The most common adverse events in ruxolitinib-treated patients were thrombocytopenia (52.4%), anemia (49.2%), diarrhea (35.6%), and peripheral edema (33%).
The most common grade 3/4 adverse events included anemia (22.5%), thrombocytopenia (15.2%), pneumonia (5.8%), general physical health deterioration (4.2%), and shortness of breath (4.2%).
“This long-term analysis after a vast number of patient-years shows the ongoing benefit, with no new safety signals and a strong survival message,” Dr Harrison said.
“Hematologists can be confident treating patients with ruxolitinib. It is safe, effective, and leads to significant long-term benefit. Myelofibrosis patients feel better, their spleens are smaller, and they may survive longer.”
COMFORT-II was sponsored by Novartis, which licensed ruxolitinib from Incyte Corporation for development and commercialization outside the US. COMFORT-I was sponsored by Incyte.