Swedish biotech company BioInvent International AB (STO:BINV) announced on Friday that the US Food and Drug Administration (FDA) has granted Fast Track designation to its first-in-class anti-TNFR2 antibody BI-1808, in combination with pembrolizumab, for the treatment of ovarian cancer.

Interim Phase 2a data presented at ASCO 2026 showed BI-1808 plus pembrolizumab achieved a 24% confirmed overall response rate and a 56% disease control rate in heavily pretreated patients with advanced platinum-resistant ovarian cancer.

The company said the combination demonstrated durable benefit across high-grade serous and clear cell subtypes, with several responses ongoing beyond 10 months and a preliminary median progression-free survival of 10.3 months.

Cohort expansion is underway with a focus on high-grade serous and clear cell ovarian cancer, and another data readout is expected in the second half of 2026.