Onconova Therapeutics Inc. (NASDAQ:ONTX) announced the e-publication of its Phase 1 oral rigosertib study results in combination with azacitidine in treating acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (HR-MDS) patients. The results were published in the hematological malignancy journal Leukaemia Research.
Oral rigosertib combination offering a convenient way of administration
Steven Fruchtman, the CEO and President of Onconova, stated the main emerging strategy in MDS treatment is identifying effective and safe combinations, especially those involving oral agents. The phase 1 study results show company’s initial efforts explore an oral rigosertib combination with azacitidine to address unmet medical needs in AML and MDS patients. Fruchtman added that Onconova is anticipating an FDA meeting combined with the vital data readout from the INSPIRE study for alignment on a registration study. The study will evaluate the combination of oral rigosertib and azacitidine to cure HMA-naïve HR-MDS.
According to the study’s lead investigator, Lewis Silverman, the results and the initial data from phase two trials support further clinical development of the combination. He said that the novel combination has a manageable safety and efficacy profile in MDS patients for those with after HMA failure and HMA naïve. Lewis added that the use of oral rigosertib is convenient for patients and will also enhance treatment compliance, resulting in improved clinical results.
Onconova evaluated phase 2 does for future studies
The results published were from the Phase 1 open-label, dose-escalating study of oral rigosertib in combination with standard dose azacitidine. The combination was administered sequentially to HR-MDS patients after HMA-failure or refractory/relapsed AML. Onconova’s objective was to evaluate the safety and recommended the second phase dose for future trials. Three dose cohort was assessed in the study, and there were no toxicities reported.
Onconova’s Chief Medical Officer, Richard Woodman, indicated that they are optimistic that the combination will be beneficial to higher-risk MDS patients. Woodward confirmed that besides rigosertib being an oral formulation, thus easing administration, it also has the potential of being used in other combinations as a RAS mimetic.