Genmab meets both survival goals in Rina-S trial, cuts risk of disease progression by 71%
Key Facts
Genmab said on October 23, 2026, that the Phase III RAINFOL-02 trial of Rina-S met its primary endpoint of progression-free survival and its main secondary endpoint of overall survival in patients with platinum-resistant ovarian cancer. The trial compared the drug with investigator’s choice chemotherapy, and results showed improvement in both the ITT and PAS analysis populations. The company’s chief executive said the positive results represent an "important milestone" for the program and strengthen Genmab’s confidence in Rina-S’s potential. The announcement comes as the company continues to evaluate the drug in a broader clinical program. GMAB shares closed at $43.79 on October 23, compared with a close of $40 in the previous session.
In the ITT population, Rina-S reduced the risk of disease progression or death by 71% compared with chemotherapy, with a hazard ratio of 0.29. In the PAS population, the risk reduction was 67%, with a hazard ratio of 0.33. Overall survival results showed a hazard ratio of 0.43 in ITT, with a 95% confidence interval of 0.31 to 0.59 and p<0.0001. In PAS, the hazard ratio for overall survival was 0.44, with a 95% confidence interval of 0.31 to 0.63 and p<0.0001. Genmab said the improvement in both populations was statistically significant and clinically meaningful.
RAINFOL-02 was a global, randomized, open-label, multicenter trial that enrolled patients with platinum-resistant ovarian cancer regardless of their level of FRα expression. Participants were randomly assigned in a 1:1 ratio to Rina-S or investigator’s choice chemotherapy. Patients received Rina-S at a dose of 120 mg/m² on the first day of a three-week treatment cycle. Comparator options included paclitaxel, topotecan, pegylated liposomal doxorubicin or gemcitabine. The comparison was therefore based on specified standard chemotherapy options within the trial design.
The company said the observed safety profile was consistent with Rina-S’s known profile, with no new safety signals or unexpected concerns identified. Genmab had previously announced results from the Phase II RAINFOL-01 trial in October 2026, in which the drug recorded a confirmed objective response rate of 45.9% among 109 patients with platinum-resistant ovarian cancer, including five complete responses. The Phase III results now provide survival data alongside the response results reported by the company in the earlier phase. Rina-S’s clinical program includes five Phase III trials spanning platinum-resistant ovarian cancer and other gynecological cancers. Genmab said it will discuss the RAINFOL-02 results and potential next steps with regulators around the world, and will present the data at a future medical meeting.
In trading, Genmab shares rose about 9% on Friday, October 23, after the Phase III results announcement, according to Investing.com. In the same session, Corcept shares fell 11% amid mixed moves across the sector. Available closing data show GMAB’s price moving from $40 on October 22 to $43.79 on October 23. Genmab did not announce a regulatory filing; it said it would discuss the results and potential next steps with the relevant authorities. The company scheduled an investor update for October 28 at 5:00 p.m. Central European Time, or 12:00 p.m. Eastern Time.