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COMFORT-II was the European companion to COMFORT-I: ruxolitinib shrank the spleen by more than a third in 28 percent of people with myelofibrosis after nearly a year, while not one patient on the best treatment their doctor could otherwise offer achieved that, and symptoms and quality of life improved.
COMFORT-II was an open-label phase 3 trial in Europe that randomised 219 patients with intermediate-2 or high-risk myelofibrosis two to one to ruxolitinib or best available therapy, which for most patients meant hydroxycarbamide or no treatment. The primary endpoint was a spleen volume reduction of at least 35 percent at week 48 on MRI or CT, with the same reduction at week 24 as the key secondary endpoint.
At week 48, 28 percent of the ruxolitinib group had reached the spleen endpoint against none on best available therapy, responses were durable, and role functioning and quality-of-life scores improved. Toxicity was modest, mainly anaemia and thrombocytopenia. The trial supported the European approval of ruxolitinib in 2012, and pooled long-term analyses with COMFORT-I later suggested a survival advantage.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
219 enrolled.
Shares Ruxolitinib, Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis), Small-molecule kinase inhibitors and the tag soc-trials.
Shares Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis), Small-molecule kinase inhibitors and the tag soc-trials.
Shares Ruxolitinib, Small-molecule kinase inhibitors and the tag soc-trials.
Shares Novartis and the tag soc-trials.
Shares Novartis, Small-molecule kinase inhibitors and the tag soc-trials.
Shares Small-molecule kinase inhibitors and the tag soc-trials.
Shares Small-molecule kinase inhibitors and the tag soc-trials.
Shares Small-molecule kinase inhibitors and the tag soc-trials.