A phase 1/2 study of XXXX in Japanese adults with @entity1860 .

@entity1 @entity8947 @entity137 @entity11266 @entity1910 @entity31438 @entity294 @entity1349 @entity204 @entity1860 @entity10542 @entity2213
UNASSIGNED: This phase 1/2 study evaluated the safety and pharmacokinetics (part 1) and efficacy and safety (part 2) of @entity31438 in Japanese Philadelphia chromosome-positive (Ph+) chronic-phase (CP) or advanced-phase @entity1860 ( @entity1860 ) @entity1 resistant/intolerant to previous @entity2213 (2L) or @entity2213 + @entity8947 / @entity10542 (3L). Based on dose-limiting @entity137 and previous studies, the part 2 @entity31438 starting dose was 500  mg/day (n  =  63). For CP @entity1860 2L (n  =  28), the cumulative major cytogenetic response (MCyR) rate by week 24 was 36  % (primary endpoint); the cumulative major molecular response (MMR) rate through the study was 43  %. Transformation to accelerated/blast phase (AP/BP) was observed in one @entity1 . Progression-free survival (PFS) and @entity1349 ( @entity1349 ) rates at 96  weeks were 94 and 96  %, respectively. Of seven advanced-phase 2L @entity1 , one had confirmed complete hematologic response at week 84, and one had AP/BP transformation. PFS and @entity1349 rates at week 96 were 21 and 43  %. For 3L (n  =  11), cumulative MCyR rate by week 24 was 18  %; cumulative MMR rate was 18  %; no transformations occurred. Common non-hematologic adverse events (AEs) were @entity294 (95  %), @entity1910 (57  %), and @entity11266 (51  %). Sixteen @entity1 discontinued due to adverse events; no @entity204 occurred within 30  days of the last dose. @entity31438 500  mg/day demonstrated efficacy and manageable @entity137 in Japanese Ph+ @entity1860 @entity1 resistant/intolerant to @entity2213 .
