Torvu-Sam Clinical Trial Results in Platinum-Resistant Ovarian Cancer
Updated phase 1/2a FONTANA trial results show confirmed overall response rates of 61.7% in FRα-high, 57.1% in FRα-low, and 48.1% in FRα-ultralow or null platinum-resistant ovarian cancer patients treated with the antibody-drug conjugate torvu-sam, OncLive reported.
Dose Optimization and Patient Demographics in the FONTANA Trial
The dose optimization portion of the open-label trial enrolled patients whose tumors expressed folate receptor alpha in at least 25% of tumor cells or exhibited a membrane intensity of 1+ or higher via immunohistochemistry. The broader trial evaluated patients with a median age of 64 years. Prior therapies among participants included bevacizumab in 67.9% of cases, PARP inhibitors in 60.3%, and mirvetuximab soravtansine-gynx in 2.6%, according to data presented at the 2026 ESMO Congress in Madrid, Spain.
Safety Profile and Adverse Events Across Dose Levels
Patients received intravenous torvu-sam at 1.6 mg/kg, 2.0 mg/kg, or 2.4 mg/kg every three weeks. All participants experienced at least one treatment-emergent adverse event of any grade. Grade 3 or higher adverse events occurred in 45.3% of patients at the 1.6-mg/kg level, 60.0% at the 2.0-mg/kg level, and 82.8% at the 2.4-mg/kg level. The most common adverse events included nausea, fatigue, neutropenia, anemia, and vomiting.
Upcoming Phase 3 TREVI-OC Trial Evaluations
Three phase 3 trials under the TREVI-OC program are scheduled to evaluate the antibody-drug conjugate further. The TREVI-OC-01 trial will compare torvu-sam against mirvetuximab soravtansine in FRα-high disease and against chemotherapy in FRα-low disease. Additional evaluations will assess the therapy combined with bevacizumab as maintenance treatment.
Frequently Asked Questions About Torvu-Sam in Ovarian Cancer
What were the median progression-free survival rates observed in the trial?
Median progression-free survival with torvu-sam monotherapy reached 9.7 months in patients with FRα-high disease and 7.6 months in those with FRα-low disease.
What molecular responses were measured using circulating tumor DNA?
Among evaluable patients with detectable circulating tumor DNA at baseline, the complete molecular response rate reached 47%, while the overall rate for any molecular response was 87%.
When and where were the FONTANA trial findings presented?
The findings were presented at the 2026 ESMO Congress held in Madrid, Spain, which ran from October 23 to October 27, 2026, as detailed by OncLive.
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