On Saturday, Genmab A/S ( GMAB ) revealed updated data from cohort B2 of the Phase 1/2 RAINFOL-01 trial evaluating rinatabart sesutecan (Rina-S) in heavily pretreated patients with advanced endometrial cancer.

The study showed that at a median study follow-up of one year, treatment with Rina-S 100 mg/m² every 3 weeks (Q3W) resulted in a 50.0% confirmed objective response rate (ORR), including two complete responses (CR).

ORR is the percentage of patients in a study whose cancer shows a significant, measurable reduction in size or a complete disappearance after treatment.

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Additionally, at a median study follow-up of one year, 63.6% of responders (including CRs) in the 100 mg/m² cohort maintained their responses and remain on treatment. The responses were observed regardless of FRα expression levels.

The updated results were presented at the European Society for Medical Oncology (ESMO) Congress.

Continued evaluation of single-agent Rina-S 100 mg/m2 in patients with advanced endometrial cancer is ongoing in the Phase 2 RAINFOL-01 trial and the Phase 3 RAINFOL-03 trial.

The B2 cohort of the Phase 1/2 RAINFOL-01 study is a dose expansion cohort evaluating the efficacy and safety of Rina-S in patients with advanced or recurrent endometrial cancer.

In the study, 64 patients with heavily pretreated advanced or recurrent endometrial cancer whose disease had progressed on or after an anti-PD-(L)1 and platinum-based chemotherapy were enrolled and treated with Rina-S.

Patients were administered either 100 mg/m2 (n=22) (selected dose for Phase 3 clinical trial) or 120 mg/m2 (n=42) of Rina-S. In the 100 mg/m2 cohort, the confirmed ORR was 50%, including two CRs.

Anti-tumor activity was also observed in patients treated with Rina-S 120 mg/m2 Q3W, which resulted in 44.1% confirmed ORR and one CR.

Common treatment emergent adverse events (TEAEs; all grades) consisted primarily of cytopenias and low-grade gastrointestinal (GI) events. To date, there have been no signals of ocular toxicities, neuropathy, or interstitial lung disease (ILD) observed in Rina-S clinical trials, consistent with prior reports.

Price Action: GMAB stock is down 6.57% at $30.99 at the last check on Monday.

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