‘Majic-PV’ clinical trial comparing ruxolitinib vs BAT for hydroxyurea resistant/intolerant PV
The MAJIC-PV trial studied ruxolitinib for PV patients against best available therapy (BAT) which in this case was mainly hydroxycarbamide (hydroxyurea). It concluded that ‘ruxolitinib treatment benefits hydroxyurea intolerant or resistant patients with superior complete [haematological] response, and event free survival as well as molecular response; importantly also demonstrating for the first time, to our knowledge, that molecular response is linked to event free survival, progression free survival, and overall survival.’
Watch Dr Claire Harrison MD, FRCP, FRCPath, Guy’s and St Thomas’s NHS Foundation Trust discuss the results from the MAJIC-PV trial: ruxolitinib vs BAT for hydroxyurea resistant/intolerant PV.
Jean-Jacques Kiladjian further explains in a recent talk about ‘State of the art in PV’, that the MAJIC study also showed that ‘Patients having a complete haematological response during the first year of treatment had a significantly better event free survival than those who did not. So this is for the first time, an evidence that normalising the blood count, results in benefits in terms of less complications during the follow up. And the other point is …… that this event free survival was also better in patients who achieved a molecular response (reduction in allele burden) compared to those who did not. …….
So to summarise, …….we have to optimise [PV] management by recognising resistance in tolerance to first line therapy, and switch quickly to second line therapy because….achieving complete haematological response within 12 months results in better long term outcomes.’
Image: screenshot of the MAJIC trial outcomes showing: superiority of ruxolitinib in event free survival for patients intolerant or resistant to HU; and also the benefits to PV patients of achieving a complete haematological response within 12 months
While not specifically addressed in the MAJIC study, pegylated interferon is also an existing alternative first line treatment to hydroxycarbamide for PV patients. However about 20% of patients are unable to tolerate interferon and so a need remains for effective additional treatments. Of interest is that the MITHRIDATE trial now underway in the UK and France is comparing ruxolitinib with hydroxyurea and with pegylated interferon.