WASHINGTON (dpa-AFX) - Genmab A/S (GMAB) reported positive results from Part C of the Phase 1/2 RAINFOL-01 trial evaluating investigational antibody-drug conjugate rinatabart sesutecan (Rina-S) in patients with platinum-resistant ovarian cancer.
Among 109 treated patients, Rina-S achieved a confirmed objective response rate (ORR) of 45.9%, including five complete responses. The therapy delivered a median duration of response of 12.1 months, while 51% of responders remained in response after one year.
The study also showed a median progression-free survival of 9.5 months. Investigators reported antitumor activity across all levels of folate receptor alpha (FR?) expression, including patients with low FR? expression and those with no detectable expression. Responses were also observed regardless of prior treatment with mirvetuximab.
The Part C cohort evaluated Rina-S at a dose of 120 mg/m² administered every three weeks as monotherapy in patients with platinum-resistant high-grade serous ovarian, primary peritoneal or fallopian tube cancer.
Patients enrolled in the study had received one to three prior lines of therapy, while some previously treated with mirvetuximab had received up to four prior treatment lines. More than half of study participants had undergone three or four prior therapies. All patients had previously received bevacizumab and taxane treatment, while nearly half had received PARP inhibitors and one-third had been treated with mirvetuximab soravtansine.
Safety findings were generally consistent with the known profile of Rina-S. The most common treatment-emergent adverse events included fatigue, nausea, vomiting, constipation, decreased appetite and abdominal pain. Hematologic adverse events included anemia, neutropenia, decreased platelet count and thrombocytopenia.
Serious adverse events occurred in about one-third of participants, while treatment discontinuation due to adverse events was reported in 5.5% of patients. The study did not identify safety signals related to ocular toxicity, peripheral neuropathy, interstitial lung disease or stomatitis.
The results support the continued clinical development of Rina-S as a potential treatment option for patients with platinum-resistant ovarian cancer, a population with significant unmet medical needs.
GMAB closed Friday's regular trading at $34.75 up $0.20 or 0.58%.
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