Pevonedistat demonstrates encouraging EFS data in a phase 2 trial in MDS

Justin M. Watts, Ph.D. Med., Discusses a key exemption from phase 2 study P-2001 of a clinical trial, a randomized study comparing the safety and efficacy of pevonedistat in combination with azacitidine in patients with high-risk myelodiplastic syndromes.

Justin M. Watts, Ph.D. Med., An assistant professor of medicine at the Sylvester Comprehensive Cancer Center, University of Miami Health System, discusses a key exemption from phase 2 study P-2001 of a clinical trial (NCT02610777), a randomized study comparing the safety and efficacy of pevonedistat in combination with azacitidine alone. azacitidine in patients with high-risk myelodysplastic syndromes (MDS).

A study of 120 patients provided fairly reliable data with improved event-free survival (EFS) after 5 months, Watts says. There was also an improvement in the overall remission rate and duration of response. Watts notes that this is just 1 of the active assets currently being developed at MDS, which is a good problem.

The difference with pevonedistat and other active developing agents is that response rates are comparable, but these are randomized phase 2 data with new EFS benefits, which remains to be seen in phase 3, where the primary endpoint is EFS. However, Watts notes that this regimen is attractive because of its minimal toxicity, especially when added to azacitidine.

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