| Trial ID # | NCT03386942 |
| Phase | I |
| Drug Class | Antibody Drug Conjugates: FRalpha |
| Drug Name | Farletuzumab ecteribulin |
| Alternate Drug Names | MORAb-202 |
| Drugs in Trial | Farletuzumab ecteribulin |
| Eligible Participant | Platinum resistant ovarian cancer |
| Patients Enrolled | 45, median 3 prior therapies |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, DoR, PFS, OS, evaluated per RECIST |
| Biomarkers | FRalpha+ (>5% cells with FRalpha IHC +1, +2 or +3) |
| Efficacy | MORAb-202 0.9 mg/kg (n=24): ORR: 25% (1CR, 5PR) MORAb-202 1.2 mg/kg (n=21): ORR: 52.4% (11PR) |
| Clinically Significant Adverse Events | MORAb-202 0.9 mg/kg vs 1.2 mg/kg: |
| Conclusion | Anti-tumor activity is seen with both the farletuzumab ecteribulin (MORAb-202) 0.9 mg/kg and 1.2 mg/kg doses and efficacy is observed irrespective of FRalpha-expression levels. Ongoing body surface area-based dosing is predicted to lower the exposure-dependent pneumonits/interstitial lung disease risk |
| Reference | Hayato S et al. Dose optimization for MORAb-202, an antibody-drug conjugate (ADC) highly selective for folate receptor-alpha, using population pharmacokinetic (PPK) and exposure-response (E-R) efficacy and safety analyses. J Clin Oncol 40, 2022 (suppl 16; abstr 3090) Hayato S et al. Poster Nishio S et al. Safety and efficacy of MORAb-202 in patients (pts) with platinum-resistant ovarian cancer (PROC): Results from the expansion part of a phase 1 trial. J Clin Oncol 40, 2022 (suppl 16; abstr 5513) Nishio S et al. Poster |