Figure 1.
Study design and patient flow. The study pooled 13 patients from phase 1 and 9 patients from phase 2 who entered the study with MDS. Three patients from the phase 1 study received a suboptimal, lower than recommended dose of olutasidenib (OLU) monotherapy (100-150 mg daily). The remaining 3 monotherapy patients received the full dose of OLU at 150 mg, twice daily. Seven patients from the phase 1 study received combination therapy of OLU + AZA (OLU + AZA). When combined with 9 patients from the phase 2 study, 16 total patients with MDS received OLU + AZA. The safety population or FAS comprised 22 patients, of whom 6 received some form of OLU monotherapy and 16 received OLU + AZA combination therapy. The response-evaluable population excluded 1 patient from the monotherapy group and 2 patients from the combination therapy group who did not have any response assessments during the study. The response-evaluable population consisted of 2 TN patients who received OLU monotherapy and 5 TN patients who received OLU + AZA for a total of 7 TN patients evaluated for response; and 3 R/R patients who received OLU alone and 9 R/R patients who received OLU + AZA for a total of 14 R/R patients evaluated for response. BID, twice daily; QD, daily.

Study design and patient flow. The study pooled 13 patients from phase 1 and 9 patients from phase 2 who entered the study with MDS. Three patients from the phase 1 study received a suboptimal, lower than recommended dose of olutasidenib (OLU) monotherapy (100-150 mg daily). The remaining 3 monotherapy patients received the full dose of OLU at 150 mg, twice daily. Seven patients from the phase 1 study received combination therapy of OLU + AZA (OLU + AZA). When combined with 9 patients from the phase 2 study, 16 total patients with MDS received OLU + AZA. The safety population or FAS comprised 22 patients, of whom 6 received some form of OLU monotherapy and 16 received OLU + AZA combination therapy. The response-evaluable population excluded 1 patient from the monotherapy group and 2 patients from the combination therapy group who did not have any response assessments during the study. The response-evaluable population consisted of 2 TN patients who received OLU monotherapy and 5 TN patients who received OLU + AZA for a total of 7 TN patients evaluated for response; and 3 R/R patients who received OLU alone and 9 R/R patients who received OLU + AZA for a total of 14 R/R patients evaluated for response. BID, twice daily; QD, daily.

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