Authors: Rachel Jenkins, Future Science Group
SOLO-1 is the first, double-blind, randomized, prospective Phase III trial to evaluate front-line olaparib maintenance therapy after platinum-based chemotherapy in newly diagnosed advanced ovarian cancer with BRCA mutation.
In total, the study included 391 patients with high grade serous or endometrioid ovarian cancer who were in clinical complete or partial response after chemotherapy. The patients were randomized, 2:1, to olaparib tablets (n=260) or placebo (n=131) for 2 years.
The primary endpoint was investigator-assessed progression-free survival (PFS) from randomization. Median follow-up was 41 months.