The trial randomized patients regardless of their level of folate receptor alpha (FRα) expression to Rina-S or the investigator’s choice of chemotherapy (paclitaxel, topotecan, pegylated liposomal doxorubicin or gemcitabine). In the full intent-to-treat population of 584 patients, Rina-S reduced the risk of disease progression or death by 71% (HR 0.29) and the risk of death by 57% (HR 0.43). Results in the primary analysis set of 492 patients were similar, with hazard ratios of 0.33 for progression-free survival and 0.44 for overall survival. The safety profile was consistent with earlier data, with no new safety signals.

Rina-S targets FRα and carries exatecan, a topoisomerase I inhibitor, as its payload. RAINFOL-02 is the first Phase 3 readout for the drug, which is also being tested in four further Phase 3 trials in ovarian and endometrial cancer. Genmab plans to discuss the results with regulators worldwide and will submit the data for presentation at a future medical meeting. The company hosts an investor update on October 28.

“As the first Phase 3 readout from our Rina-S program, the positive topline results from RAINFOL-02 mark a significant milestone for Genmab and strengthen our confidence in Rina-S’s potential for patients with platinum-resistant ovarian cancer,” says Jan van de Winkel, CEO of Genmab.