Genmab A/S reports 45.9% Rina‑S response in ovarian cancer trial
Among 109 treated patients, the median response lasted 12.1 months; the single-arm cohort offers no direct efficacy comparison.
Adrian Kessler
A 45.9 per cent confirmed tumour response rate has given Genmab A/S NASDAQGMAB fresh evidence for its ovarian cancer drug Rina-S after the company presented new RAINFOL-01 data in Montreal on Saturday. The Oct. 3 release says responses lasted a median 12.1 months among responders in a group of 109 treated patients.
The Phase 1/2 study's Part C cohort gave every patient Rina-S alone at 120 milligrams per square metre every three weeks. Its response rate had a 95 per cent confidence interval of 36.3 to 55.7 per cent, but there was no control arm or between-arm p value to establish a benefit over chemotherapy.
Genmab is a Copenhagen-based antibody developer with commercial medicines and an oncology pipeline. Its Nasdaq depositary shares closed Friday at US$34.75 as of 4:00:01 p.m. EDT on NASDAQGMAB; the close preceded Saturday's presentation and cannot show a share reaction.
The company says its Phase 3 RAINFOL-02 trial in platinum-resistant ovarian cancer is part of a broader Rina-S program. Its next financial report is due Nov. 5, giving shareholders a dated view of overall spending as the trial proceeds.
Response Durability Comes From One Treated Group
Genmab reported median progression-free survival of 9.5 months, with a 95 per cent confidence interval of 7.6 to 11.3 months. The response tally included five complete responses, and 51 per cent of responders remained in response at one year. Those measures describe outcomes in the treated cohort rather than a comparison with patients receiving another therapy.
All participants had previously received bevacizumab and a taxane, and 53 per cent had received three or four previous treatment lines. About one-third had previously received mirvetuximab soravtansine. Genmab said activity appeared across folate receptor alpha expression levels, including low expressors and nonexpressors, although the reported summary did not give separate response rates for those groups.
Serious adverse events occurred in approximately one-third of participants, while 5.5 per cent stopped treatment because of treatment-emergent adverse events. Nausea affected 67.9 per cent and neutropenia 57.8 per cent; Genmab said it saw no safety signal for ocular toxicity or interstitial lung disease. The Oct. 3 release reported no FDA feedback endorsing this single-arm cohort as a basis for approval.
“As our Phase 3 program continues to advance, the results further inform our evaluation of Rina-S as a potential treatment option for patients with gynecologic cancers,” Genmab chief medical officer Tahamtan Ahmadi said in the release.
Genmab's Aug. 6 interim report recorded US$555 million in operating profit for the first half of 2026. Adjusted operating expenses rose to US$1.27 billion from US$993 million in the comparable 2025 period, partly reflecting development of Rina-S and petosemtamab.
Rivals Differ on Folate Receptor Eligibility
AbbVie NYSEABBV won full U.S. approval in March 2024 for Elahere in adults with folate receptor alpha-positive, platinum-resistant ovarian, fallopian tube or primary peritoneal cancer after one to three prior regimens. That label requires an FDA-approved test, so Genmab's reported activity in lower expressors would address a different eligibility question if subsequent studies confirm it.
Sutro Biopharma, Inc. NASDAQSTRO said in an April 2024 release that its luvelta trial was comparing a folate receptor alpha-targeted drug with chemotherapy in patients whose tumours met its expression threshold. Different entry rules and trial designs prevent a direct ranking of the companies' response rates.
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The State Street SPDR S&P Biotech ETF NYSEARCAXBI was quoted at US$154.43 as of 8:00:00 p.m. EDT on Friday. That sector print also predates the RAINFOL-01 presentation, leaving Genmab's next trading session to show whether investors reprice the result.
Genmab's Nov. 5 interim report will show whether operating expenses have climbed from the first-half pace as RAINFOL-02 advances. The Oct. 3 release gives no date for a Phase 3 efficacy readout.
