Genmab reports positive Phase 1/2 data for Rina‑S in platinum‑resistant ovarian cancer

Genmab A/S announced results from Part C of its Phase 1/2 RAINFOL‑01 trial of the antibody‑drug conjugate rinatabart sesutecan (Rina‑S) in patients with platinum‑resistant ovarian cancer. Among 109 treated patients the drug achieved a confirmed objective response rate of 45.9%, a median duration of response of 12.1 months and a median progression‑free survival of 9.5 months. The efficacy was observed across all levels of folate‑receptor‑alpha expression and irrespective of prior mirvetuximab therapy.

Genmab said the data support advancing Rina‑S into Phase 3 trials, indicating a potential new treatment for a high‑unmet‑need population. The company’s shares rose more than 4% after the announcement, reflecting investor optimism about future revenue from the program.

  • 1The trial enrolled 109 patients with platinum‑resistant high‑grade serous ovarian, primary peritoneal or fallopian tube cancer.
  • 2Confirmed objective response rate (ORR) was 45.9%, including five complete responses.
  • 3Median duration of response (mDOR) was 12.1 months, with 51% of responders still in response after one year.
  • 4Median progression‑free survival (mPFS) was 9.5 months.
  • 5Rina‑S was administered at 120 mg/m² every three weeks as monotherapy.
  • 6Serious adverse events occurred in about one‑third of participants and 5.5% discontinued treatment because of side effects.

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