Mikkael Sekeres, MD, director of the Leukemia Program and vice-chair for Clinical Research at the Cleveland Clinic Taussig Cancer Institute, discusses a phase 2 study (NCT02610777) of pevonedistat plus azacitidine (Vidaza) versus azacitadine monotherapy in patients with higher-risk myelodysplastic syndromes (MDS)/chronic myelomonocytic leukemia (CMML) or low-blast acute myelogenous leukemia (LB AML).
Sekeres says that he and the other investigators were happy to see that the adverse events and serious adverse events did not seem to have a difference in rates between the monotherapy and the combination for patients.
The primary end point of this trial was event-free survival (EFS), which favored pevonedistat and azacitidine over the azacitidine monotherapy at 21 months compared with 16.6 months, respectively. There was a trend towards significance for EFS, according to Sekeres. This study was not powered for overall survival (OS), but numerically OS favored the combination at about 22 months versus 19 months with monotherapy.
For patients who had higher risk MDS specifically, the median EFS was 20 months on the combination arm and 15 months on the monotherapy arm, which was significant. For those patients, median OS was 24 months and 19 months for the combination and monotherapy, respectively. Sekeres says there was a trend toward significance for patients with LB AML, with a median OS of 24 months with pevonedistat and 16 months without.
Sekeres concluded that the combination therapy was tolerable for this patient population and had a strong signal of activity for EFS in the overall population as well as the OS for patients with LB AML.
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