Genmab's Rina-S hit primary endpoints in a Phase 3 ovarian cancer trial, showing a 71% reduction in disease progression risk and paving the way for global regulatory discussions.
Genmab reported positive topline results from its Phase 3 RAINFOL-02 trial, where its investigational ADC, Rina-S, met both primary and key secondary endpoints in patients with platinum-resistant ovarian cancer. The drug demonstrated a 71% reduction in the risk of disease progression or death in the ITT population, significantly outperforming investigator’s choice chemotherapy. These results represent a major clinical milestone that strengthens Genmab's gynecologic oncology pipeline and sets the stage for upcoming regulatory discussions.
The primary endpoint was investigator-assessed progression-free survival (PFS).
In the ITT population, Rina-S demonstrated a 71% reduction in the risk of disease progression or death compared to investigator’s choice chemotherapy.
No, Rina-S is an investigational antibody-drug conjugate and its safety and efficacy have not yet been established by regulatory authorities.
Genmab A/S announced positive topline results from its Phase 3 RAINFOL-02 trial, showing that its investigational drug Rina-S significantly improved progression-free survival in patients with platinum-resistant ovarian cancer. The study met both primary and key secondary endpoints, demonstrating a 71% reduction in the risk of disease progression or death in the intent-to-treat population.
Rinatabart sesutecan (Rina-S) is an investigational antibody-drug conjugate (ADC) that targets folate receptor alpha (FRα) and uses a topoisomerase I inhibitor payload to treat cancer.
The trial demonstrated a statistically significant improvement in progression-free survival compared to standard chemotherapy, with a 71% reduction in disease progression risk in the intent-to-treat population.