Phase 3 Win: Rina-S Cuts Ovarian Cancer Progression Risk 71%, Extends Survival
GMAB sits 72% above its 52-week low of $23.62.
Summary
Genmab's Rina-S hit both endpoints in the Phase 3 RAINFOL-02 trial in platinum-resistant ovarian cancer, regardless of FRα expression. In the intent-to-treat population of 584 patients, the ADC cut the risk of progression or death by 71% (HR 0.29; 95% CI 0.23-0.37; p<0.0001) and the risk of death by 57% (HR 0.43; 95% CI 0.31-0.59; p<0.0001), both highly significant. In the PAS population (N=492), a subset of ITT that includes only patients with FRα expression <75% PS2+ and patients previously treated with mirvetuximab if eligible based on FRα expression ≥75% PS2+ and available in the region, Rina-S demonstrated a 67% reduction in the risk of disease progression or death (HR 0.33; p<0.0001) and met the key secondary endpoint of overall survival (HR 0.44; p<0.0001). The trial evaluated 582 patients, with patients randomized 1:1 and the primary endpoint investigator-assessed PFS; Rina-S was given at 120 mg/m² on Day 1 of each three-week treatment cycle against investigator's choice of paclitaxel, topotecan, PLD, or gemcitabine, and other secondary endpoints included PFS by blinded independent central review, duration of response, incidence of adverse events and laboratory abnormalities, time from randomization to second disease progression or death, and change from baseline in global health status/quality of life. The result matters because it covers the broad population, not just FRα-high patients, which widens the addressable market well beyond mirvetuximab-type competitors. This is the first Phase 3 readout from the Rina-S program and follows the Phase 2 data reported on October 3rd, which showed a 45.9% confirmed response rate. Safety was consistent with the known profile, with no new signals. Genmab plans to engage with regulatory authorities worldwide regarding potential next steps and hosts an investor update on October 28 at 5:00 p.m. CET, with the data to be submitted for presentation at a future medical meeting.
Updated with an SEC 6-K filing · What changed
Updates
· SEC 6-K — In the PAS population (N=492), Rina-S demonstrated a 67% reduction in the risk of disease progression or death (HR 0.33; p<0.0001) and met the key secondary endpoint of overall survival (HR 0.44; p<0.0001).
- ITT Results — In the ITT population, PFS HR was 0.29 (95% CI 0.23-0.37; p<0.0001) and OS HR was 0.43 (95% CI 0.31-0.59; p<0.0001).
- PAS Subgroup Results — The PAS subset (N=492) of ITT includes only patients with FRα expression <75% PS2+ and patients previously treated with mirvetuximab if eligible based on FRα expression ≥75% PS2+ and available in the region.
- Trial Design — The trial evaluated 582 patients, with an ITT population of N=584; patients were randomized 1:1 with primary endpoint investigator-assessed PFS and key secondary endpoints OS and objective response rate.
- Dosing and Comparator — Rina-S was given at 120 mg/m² on Day 1 of each three-week treatment cycle, compared with investigator's choice of paclitaxel, topotecan, PLD, or gemcitabine.
- Other Endpoints — Other secondary endpoints include PFS by blinded independent central review, duration of response, incidence of adverse events and laboratory abnormalities, time from randomization to second disease progression or death, and change from baseline in global health status/quality of life.
- Next Steps — Data will be submitted for presentation at a future medical meeting, and Genmab plans to engage with regulatory authorities worldwide regarding potential next steps.
All 12 details
- ITT PFS: HR 0.29 (95% CI 0.23-0.37; p<0.0001)
- ITT OS: HR 0.43 (95% CI 0.31-0.59; p<0.0001)
- PAS (N=492) mandated patients with FRα expression ≥75% PS2+ to have been treated with mirvetuximab
- Trial evaluated 582 patients; ITT population N=584
- Rina-S 120 mg/m² on Day 1 of each three-week treatment cycle
- Comparator: investigator's choice of paclitaxel, topotecan, PLD, or gemcitabine
- Patients randomized 1:1; primary endpoint investigator-assessed PFS
- Key secondary endpoints: OS and objective response rate (ORR)
- Other secondary endpoints: PFS by blinded independent central review, duration of response, incidence of adverse events and laboratory abnormalities, time from randomization to second disease progression or death, change from baseline in global health status/quality of life
- Data will be submitted for presentation at a future medical meeting
- PAS (N=492), a subset of ITT, includes only patients with FRα expression <75% PS2+ and patients previously treated with mirvetuximab if eligible based on FRα expression ≥75% PS2+ and available in the region.
- Genmab plans to engage with regulatory authorities worldwide regarding potential next steps.
At the time of this announcement, GMAB was trading at $40.64 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $23.7B. The 52-week trading range was $23.62 to $41.75. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: BusinessWire.