On October 19, 2025 Faeth Therapeutics reported results from the international DICE trial, a randomized phase 2 study of sapanisertib (TAK228) plus weekly paclitaxel versus paclitaxel alone in women with platinum-resistant or recurrent epithelial ovarian or fallopian tube cancer. The trial was selected for a Late-Breaking Oral Presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 and met its pre-ordained statistical design and there is sufficient evidence of a positive signal to justify a larger phase 3 design.

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134 patients were enrolled across sites in the UK and Germany. Median age was 62 years and nearly half had received three or more prior therapies. The combination achieved mean progression-free survival (PFS) of 5.8 months compared to 4.0 months with paclitaxel alone, extending time to disease progress by approximately 45 percent. The addition of sapanisertib was associated with a 34% reduction in risk of progression compared to paclitaxel alone (HR=0.66; 90% CI: 0.45–0.96; p=0.07), meeting the trial’s prespecified hazard ratio target of 0.66.

Grade 3/4 adverse events occurred in 7% of patients receiving the combination versus 6.6% for paclitaxel alone. Gastrointestinal toxicities (11.4% vs. 0%) and rash (2.9% vs. 0%) were more common with the combination but were manageable.

"Platinum-resistant ovarian cancer remains one of the toughest conditions we face, with women often cycling through treatments that only briefly hold the disease at bay temporarily," said Jonathan Krell, MD, Ovarian Cancer Action Research Centre, Imperial College London, the study’s lead investigator. "The DICE trial shows that adding an oral targeted agent to weekly paclitaxel can slow progression without added high-grade toxicity, a finding that clearly warrants a phase 3 trial."

"These results reinforce our belief that targeting the metabolism of cancer cells can improve the impact of existing therapies," said Anand Parikh, JD, CEO and co-founder of Faeth Therapeutics. "On the strength of DICE, we see sapanisertib plus paclitaxel as phase 3-ready in ovarian cancer, alongside our ongoing phase 2 in endometrial cancer and planned phase 1b/2 in breast cancer."

Response rate and overall survival analyses are ongoing. The trial is also evaluating biomarkers, including PTEN expression, metabolic signatures, and genomic correlates, to identify patients most likely to benefit from the combination.

About the DICE Trial

DICE (NCT03648489) is a multi-centre randomized phase 2 study comparing weekly paclitaxel alone versus paclitaxel plus sapanisertib in women with platinum-resistant or recurrent ovarian or fallopian tube cancer. The primary endpoint is progression-free survival; secondary endpoints include response rate and overall survival. Translational endpoints include PTEN correlation and exploratory biomarker analyses.

(Press release, Faeth Therapeutics, OCT 19, 2025, View Source [SID1234656805])