Phase 3 Randomized Study of Rinatabart Sesutecan + Bevacizumab vs Bevacizumab in Recurrent Platinum‑Sensitive Ovarian Cancer after Second‑Line Platinum Doublet

The primary objective is to compare progression-free survival of Rinatabart Sesutecan plus standard of care versus standard of care alone as maintenance treatment following second‑line platinum‑based doublet chemotherapy in participants with recurrent platinum‑sensitive ovarian cancer. Secondary objectives include:

• Evaluation of additional efficacy measures of Rinatabart Sesutecan + standard of care compared with standard of care.
• Evaluation of safety of Rinatabart Sesutecan + standard of care versus standard of care.
• Evaluation of patient-reported outcomes in participants receiving Rinatabart Sesutecan + standard of care and those receiving standard of care alone.

The trial enrolled 287 female participants diagnosed with platinum-sensitive ovarian cancer. Eligible individuals were adults corresponding to age‑range codes 3 and 4, encompassing the typical adult and older adult categories. All subjects had histologically or cytologically confirmed high‑grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, and demonstrated disease progression more than 183 days after completion of first‑line platinum therapy. Participants required prior completion of second‑line platinum‑based doublet chemotherapy, with randomization occurring no later than eight weeks after the last dose of that therapy. Inclusion also mandated a documented response (complete response, partial response, or stable disease when bevacizumab was combined with platinum in the second line) and, for those with BRCA‑mutated or HRD‑positive disease, prior exposure to PARP inhibitor maintenance during first‑line treatment. The study population was classified as vulnerable, reflecting the inclusion of patients with a serious oncologic condition.

The study is a randomized, open‑label, Phase 3 trial comparing Progression‑free survival of Rinatabart Sesutecan plus standard of care versus standard of care alone as maintenance therapy after second‑line platinum‑based doublet chemotherapy in participants with recurrent platinum‑sensitive ovarian cancer. Eligible participants undergo a screening visit to confirm histologic diagnosis, platinum‑sensitive disease (>183 days since last platinum dose), and completion of second‑line therapy; randomization occurs within eight weeks of the last chemotherapy dose. Following randomization, participants receive the assigned intravenous infusion on a predefined schedule and attend regular follow‑up visits for safety monitoring, imaging assessments per RECIST 1.1, and quality‑of‑life questionnaires. The trial continues until disease progression, unacceptable toxicity, withdrawal of consent, or protocol‑specified termination, with an end‑of‑study visit performed at discontinuation. Participant involvement spans from the screening visit through the final assessment, encompassing a treatment period of up to 24 months and additional follow‑up as required. The overall recruitment period is projected from October 2026 to April 2030.

The investigational product is Rinatabart Sesutecan, supplied as a solution for infusion for intravenous administration. The protocol specifies a dose of 0.00 mg/m² delivered by intravenous infusion; the exact infusion rate and schedule are defined in the trial’s dosing regimen. Administration occurs under controlled clinical conditions to ensure consistent exposure across participants.

The non‑experimental arm utilizes bevacizumab as a comparator, administered intravenously at a dose of 0.00 mg/kg. In addition, participants in both arms receive the trial’s defined standard of care maintenance therapy following second‑line platinum‑based doublet chemotherapy, consistent with current clinical practice for recurrent platinum‑sensitive ovarian cancer.

All study drugs are given according to the predefined dosing schedule, with each infusion performed on the specified treatment days. Participant compliance is monitored through infusion records, drug accountability logs, and regular assessment of adherence to the dosing calendar. Any deviations from the protocol‑specified schedule are documented and reported in accordance with regulatory requirements.

Efficacy will be evaluated primarily by measuring progression‑free survival (PFS) using the RECIST 1.1 criteria, with tumor assessments reviewed by a blinded independent central review (BICR). Radiographic evaluations will be performed at protocol‑specified intervals and analyzed centrally to determine the time from randomization to documented disease progression or death.

Key secondary efficacy assessments include overall survival (OS) and a second determination of PFS by investigator assessment according to RECIST 1.1, as well as PFS2 and the incidence of treatment‑emergent adverse events. Patient‑reported outcomes will be captured using the Global Health Status/Quality of Life (GHS/Qol) score derived from the EORTC QLQ‑C30 questionnaire; changes from baseline and time to deterioration in this score will be analyzed to evaluate health‑related quality of life impacts.