Randomized phase 2 study in platinum-resistant ovarian cancer met its prespecified hazard ratio target and primary endpoint, supporting advancement to phase 3; combination extended mean progression-free survival by 45% compared to paclitaxel alone
Faeth Therapeutics today announced 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) 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.
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.
About Faeth Therapeutics
Faeth Therapeutics is a clinical-stage biotechnology company integrating targeted therapies with precision nutrition interventions to exploit metabolic vulnerabilities in cancer. Founded by renowned researchers from Cornell, Columbia, Cambridge, Memorial Sloan Kettering, and the Crick Institute-including Drs. Lewis Cantley, Siddhartha Mukherjee, Karen Vousden, Greg Hannon, and Scott Lowe-Faeth leverages its AI-driven MetabOS discovery platform to identify metabolic targets. Its lead clinical program, combining serabelisib and sapanisertib, is a multi-node approach to more completely inhibit the PI3K/AKT/mTOR pathway, demonstrating promising outcomes in cancers strongly associated with obesity and metabolic disorders. For more information, visit www.faeththerapeutics.com.
About Imperial College London
We are Imperial a world-leading university for science, technology, engineering, medicine and business (STEMB), where scientific imagination leads to world-changing impact.
As a global top ten university in London, we use science to try to understand more of the universe and improve the lives of more people in it. Across our 10 campuses and throughout our Imperial Global network, our 22,000 students, 8,000 staff, and partners work together on scientific discovery, innovation and entrepreneurship. Their work navigates some of the world's toughest challenges in global health, climate change, AI, business leadership and more.
Founded in 1907, Imperial's future builds on a distinguished past, having pioneered penicillin, holography and fibre optics. Today, Imperial combines exceptional teaching, world-class facilities and a habit of interdisciplinary practice to unlock scientific imagination.
View source version on businesswire.com: https://www.businesswire.com/news/home/20251019579304/en/
Contacts:
Media Contact
Patrick Schmidt
faeththerapeutics@consortpartners.com
Investor Contact
Stephanie.ascher@precisionaq.com
