Vergote I, Heitz F, Buderath P, et al. - Among patients with recurrent platinum-sensitive epithelial ovarian cancer, researchers assessed the effectiveness of ralimetinib in combination with gemcitabine (G) and carboplatin (C), followed by maintenance ralimetinib, in this phase 1b/2 clinical trial. They performed phase 1b to define the recommended phase 2 dose (RP2D) of ralimetinib given Q12H on Days 1–10 (q21d) in combination with G (1000 mg/m², Days 3 and 10) and C (AUC 4, Day 3) for six cycles. They carried out phase 2 so that patients could be randomized double-blind 1:1 to ralimetinib (R)+GC or placebo (P)+GC, for six cycles, followed by ralimetinib 300 mg Q12H or placebo on Days 1–14, q28d. For R+GC, the RP2D was 200 mg Q12H. Findings revealed a modest improvement in PFS as a result of adding ralimetinib to GC. They found R+GC therapy had a safety profile that was essentially consistent with safety of the chemotherapy backbone alone. In the ralimetinib arm, a more common detection of grade 3/4 elevated alanine aminotransferase was reported.