Ivonescimab efficacy and safety
1 evidence topic · 3 sources
Summary
HARMONi randomized 438 participants. In the 345-participant primary PFS analysis, median PFS was 6.8 months with ivonescimab plus chemotherapy and 4.4 months with placebo plus chemotherapy, with an HR of 0.52. The primary OS comparison was not statistically significant: median OS was 16.8 versus 14.0 months, with an HR of 0.79 and p=0.057. Grade 3 or higher TRAEs occurred in 50.0% versus 42.2%.
In HARMONi-A, 322 participants were randomized. Final median OS was 16.8 versus 14.1 months, with an HR of 0.74 and P=.02. Grade 3 or higher TEAEs occurred in 67.1% versus 54.7%. TEAEs and TRAEs are different safety measures and should not be treated as interchangeable.