The board of directors of Laekna, Inc. announced that the top-line data of the global MRCT Phase II registrational trial (PROFECTA-II) in both the U.S. and China to treat Platinum-Resistant Ovarian Cancer (PROC) patients with afuresertib plus paclitaxel as follows: The PROFECTA II study (NCT04374630) is a Phase II, randomized, open-label, active-controlled study evaluating the efficacy and safety of afuresertib in combination with paclitaxel versus paclitaxel in women with PROC. The study randomized 150 patients to either investigational or control treatment arm in the U.S. and China. The primary endpoint is progression-free survival, as assessed by investigators.

Secondary endpoints include overall survival, objective response rate, and duration of response. The study showed reduced risk of disease progression or death (progression-free survival; PFS) with a HR of 0.744 (95%CI: 0.502-1.102) but missed statistical significance. For biomarker subgroup with phosphor-AKT positive, IHC>1, (37%), study data demonstrated that afuresertib combination arm significantly improved PFS, and the median PFS is 5.4m vs 2.9m with HR of 0.352 (95% CI: 0.,125-0.997).

The secondary endpoint overall survival (OS) data observed a positive trend for the biomarker subgroups. The other secondary endpoints showed an increase in objective response rate and longer duration of response. The trial has shown a manageable and tolerable safety profile and adverse events were consistent with the known safety profiles of the individual treatments.

The Group will discuss the results with regulatory authorities to identify a registration path for PROC patient populations that may benefit from afuresertib. The details of the trial data will be presented in a medical conference.