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DRUG:

TOP216

i
Other names: TOP216
Associations
Trials
Company:
Valerio Therap
Drug class:
PI3K inhibitor
Related drugs:
Associations
Trials
over3years
[VIRTUAL] TREATMENT-FREE REMISSION IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA IN CHRONIC PHASE FOLLOWING FRONTLINE DASATINIB: RESULTS FROM JALSG D-STOP216 (EHA 2021)
Background Previously reported results from JALSG CML212 (UMIN000007909), a multicenter open-labeled prospective randomized controlled phase 3 study on de novo chronic myeloid leukemia in chronic phase (CML-CP), showed that cumulative achievement rates of MR4.5 (BCR-ABL1 ≤0.0032% on the International Scale [BCR-ABL1IS]) by 18 months were 33.0% (75/227) (95% CI:27.0–39.6%) in the nilotinib arm and 30.8% (70/227) (95% CI: 24.9–37.3%) in the dasatinib (DAS) arm, with no significant difference...After stopping DAS, 59.2% of patients remained in TFR 12 months later. The results suggest that a higher proportion of patients with CML-CP who achieved sustained MR4.5 on frontline DAS will remain progression free without treatment compared with that in previous TFR trials.
Clinical
|
ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
|
dasatinib • Tasigna (nilotinib) • TOP216
over3years
[VIRTUAL] TREATMENT-FREE REMISSION IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA IN CHRONIC PHASE FOLLOWING FRONTLINE NILOTINIB: RESULTS FROM JALSG N-STOP216 (EHA 2021)
Background Previously reported results from JALSG CML212 (UMIN000007909), a multicentrer open-labeled prospective randomized controlled phase 3 study on de novo chronic myeloid leukemia in chronic phase (CML-CP), showed that cumulative achievement rates of MR4.5 (BCR-ABL1 ≤0.0032% on the International Scale [BCR-ABL1IS]) by 18 months were 33.0% (75/227) (95% CI:27.0–39.6%) in the nilotinib (NIL) arm and 30.8% (70/227) (95% CI: 24.9–37.3%) in the dasatinib arm, with no significant difference...After stopping NIL, 76.5% of patients remained in TFR at 12 months later. The results suggest that a higher proportion of patients with CML-CP who achieved sustained MR4.5 on frontline NIL will remain progression free without treatment compared with that in previous TFR trials.
Clinical
|
ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
|
dasatinib • Tasigna (nilotinib) • TOP216