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Rina-S

Phase 3

Platinum-Sensitive Ovarian Cancer | Monoclonal antibody | Oncology |Genmab A/S|Last Updated: Jun 3, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment688
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07564141Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian CancerPHASE3 NOT YET_RECRUITING 688Jul 1, 2026Nov 1, 2031Jun 3, 2026 -
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Study Endpoints
Primary Endpoints
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)
Up to approximately 3 years
Secondary Endpoints
Overall Survival (OS)
Up to approximately 5 years
PFS per RECIST v1.1, as Determined by Investigator
Up to approximately 3 years
Objective Response Rate (ORR) per RECIST v1.1
Up to approximately 3 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: Rina-S ± BevacizumabEXPERIMENTALParticipants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).
Arm 2: Investigator Choice of Chemotherapy ± BevacizumabACTIVE_COMPARATORParticipants will receive carboplatin plus gemcitabine ± bevacizumab, carboplatin plus paclitaxel ± bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab.
Interventions
NameTypeDescription
Rina-SBIOLOGICALIntravenous (IV) infusion
BevacizumabDRUGIV infusion
CarboplatinDRUGIV infusion
GemcitabineDRUGIV infusion
PaclitaxelDRUGIV infusion
PLDDRUGIV infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo

Key Inclusion Criteria: * Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer. * Participant must have documented recurrence or progression after first-line (1L) platinum-based chemot...

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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07564141lastUpdatePostDate: changed
LOWJun 4, 2026NCT07564141lastUpdatePostDate: changed
LOWJun 4, 2026NCT07564141lastUpdatePostDate: changed
LOWJun 4, 2026NCT07564141lastUpdatePostDate: changed
LOWJun 4, 2026NCT07564141lastUpdatePostDate: changed
LOWMay 26, 2026NCT07564141primaryCompletionDate: changed
LOWMay 24, 2026NCT07564141studyFirstPostDate: changed
LOWMay 21, 2026NCT07564141NEW_TRIAL: changed
LOWMay 21, 2026NCT07564141NEW_TRIAL: changed