Danish pharmaceutical company Genmab reports positive topline results from the Phase 3 Rainfol-02 trial of the drug candidate rinatabart sesutecan, Rina-S, for the treatment of platinum-resistant ovarian cancer. The trial met both its primary endpoint of progression-free survival and the key secondary endpoint of overall survival, according to a press release.
In the trial, which included 584 patients, Rina-S reduced the risk of disease progression or death by 71 percent compared with physician’s choice of chemotherapy. In a predefined analysis group of 492 patients, the risk reduction amounted to 67 percent.
The trial also met its key secondary efficacy endpoint, overall survival, with a 57 percent reduction in the risk of death in the full study population and 56 percent in the predefined analysis group.
The safety profile was consistent with previous observations and no new safety signals were identified.
Genmab plans to present the results at an upcoming medical conference and discuss them with regulatory authorities worldwide.
