After GSK and Novartis handoffs, Laekna's drug fails ovarian cancer trial

Shanghai-based biotech Laekna's oral cancer drug afuresertib has failed to significantly improve progression-free survival for ovarian cancer patients in a phase 2 trial.

Originally developed by GSK, afuresertib swapped Big Pharma hands, previously falling under Novartis’ possession until being out-licensed to Laekna in 2018. That deal encompassed two oral pan-Akt kinase inhibitors—afuresertib and uprosertib—both of which originated at GSK. The two drugs have been tested against ovarian and gastric cancers, multiple myeloma, melanoma and other diseases.

Now, afuresertib has failed to meet the primary target of a global phase 2 registrational trial in platinum-resistant ovarian cancer (PROC) conducted in the U.S. and China, according to a Jan. 28 release (PDF). The open-label study, dubbed PROFECTA II, assessed afuresertib alongside the chemotherapy paclitaxel in a total of 150 patients. In the study, 94 patients received the investigational combo, while 47 received solo paclitaxel.

The drug failed to reach statistical significance on the trial’s primary endpoint of progression-free survival. However, Laekna said a phosphor-AKT positive biomarker subgroup experienced significantly improved PFS, with their median PFS reaching 5.4 months compared to 2.9 months.

The biotech reported a manageable and tolerable safety profile, with adverse events consistent with the known safety profiles of the individual treatments. Further data from the trial will be presented at an unnamed medical conference, according to the company release.

Laekna said it expects to discuss the results with regulatory authorities in hopes of identifying a registration path for PROC patients who may benefit from afuresertib.