Rina-S meets both survival endpoints in third trial involving 584 ovarian cancer patients
Key Facts
Genmab said on October 23, 2026, that the Phase 3 RAINFOL-02 trial of Rina-S met its primary endpoint of progression-free survival and its key secondary endpoint of overall survival, compared with investigator’s choice chemotherapy. The trial targets platinum-resistant ovarian cancer. The primary analysis population included 584 randomized patients, while the primary efficacy population included 492 patients. The company said the treatment reduced the risk of disease progression or death in both populations. The result included a statistically significant improvement in overall survival in the primary analysis population, making the results announcement a new milestone in the drug’s clinical development program.
In the 584-patient group, Genmab said Rina-S reduced the risk of disease progression or death by 71% compared with chemotherapy, with a hazard ratio of 0.29. In the primary efficacy population of 492 patients, the risk reduction was 67%, with a hazard ratio of 0.33. The company also announced a statistically significant improvement in overall survival in the primary analysis population, with a hazard ratio of 0.43 for that measure. The results were based on a comparison of the experimental treatment with investigator’s choice chemotherapy. The announced information did not include median overall survival or progression-free survival figures.
Genmab said the trial’s safety profile was consistent with the drug’s known profile, and that it had observed no new safety signals or unexpected concerns. The result adds an assessment component to the efficacy findings the company announced. An earlier company announcement on October 3 covered the Phase 1/2 RAINFOL-01 trial, not the new Phase 3 trial. In that announcement, the confirmed objective response rate was 45.9%, including five complete responses. The earlier trial recorded a median duration of response of 12.1 months, with 51% of responders remaining in response after one year, and median progression-free survival of 9.5 months.
In the RAINFOL-01 results, Genmab said antitumor activity was observed regardless of FRα expression levels, including in patients with low expression or no detectable expression, and regardless of prior treatment with mirvetuximab. RAINFOL-02 is a Phase 3 trial in platinum-resistant ovarian cancer, while the company’s plan includes four Phase 3 trials across different treatment indications. The plan includes one trial in platinum-resistant disease and another in recurrent or advanced endometrial cancer. It also includes maintenance treatment for platinum-sensitive ovarian cancer and its treatment in the second line. The company said it would discuss the results and potential next steps with regulators worldwide and present the data at a future medical meeting.
Genmab’s results come in a market that includes Corcept’s Lifyorli, a treatment for platinum-resistant ovarian cancer that, according to the company, received U.S. Food and Drug Administration approval in March 2026 and was then listed with nab-paclitaxel as a preferred option in NCCN guidelines in April. Corcept reported total revenue of $256.1 million in the second quarter of 2026, up 32% from the same period in 2025, and raised its full-year revenue outlook to a range of $1.1–1.2 billion. Lifyorli revenue was $47.6 million in the same quarter. The company said more than 1,300 patients had started treatment after its approval in March. RAINFOL-02’s results alone do not establish an effect on Lifyorli’s market share, as Genmab’s announcement does not include a commercial comparison between the two drugs.
These figures relate to the specified session and do not establish the stock’s performance on October 23. The previous draft had attributed a decline in the following session to results from a competing Phase 3 trial, but the results published on October 3 were from Phase 1/2, while the new Phase 3 announcement concerns Genmab and the RAINFOL-02 trial. Accordingly, the available trading data do not provide a basis for linking the October 22 session range to the October 23 announcement or determining its effect on Corcept shares. Among upcoming dates, Genmab said it would hold an investor update on October 28, 2026, at 5 p.m. Central European Time, alongside discussions of the results with regulators and a presentation at a future medical meeting.