| Trial ID # | NCT02606305; FORWARD II |
| Phase | Ib/II |
| Drug Class | Immunotherapy: Checkpoint Inhibitors/PD-1 |
| Drug Name | Pembrolizumab |
| Alternate Drug Names | Keytruda, Lambrolizumab, SCH 900475, MK3475, MK-3475 |
| Drugs in Trial | Pembrolizumab, Mirvetuximab soravtansine |
| Eligible Participant | Platinum resistant FRalpha+ ovarian cancer; IHC: ≥ 25% tumor cells at ≥ 2+ intensity |
| Patients Enrolled | 56; median 3 prior therapies (2-7) |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, PFS, RP2D, evaluated per RECIST |
| Biomarkers | FRalpha protein |
| Efficacy | RP2D: Pem 200mg + Mir 6mg/kg q3w Exploratory analysis; medium/high FRalpha: ≥ 50% of tumor cells with ≥ 2+ FRalpha expression: |
| Clinically Significant Adverse Events | Serious AE: one treatment-related death (encephalitis) |
| Conclusion | Encouraging activity in FRalpha+ patients |
| Reference | Matulonis UA et al. Initial safety and activity findings from a phase 1b escalation study of mirvetuximab soravtansine, a folate receptor alpha (Frα)-targeting antibody-drug conjugate (ADC), in combination with pembrolizumab in platinum-resistant epithelial ovarian cancer patients. SGO (2018) Abstract 74 Matulonis UA et al. Mirvetuximab soravtansine, a folate receptor alpha (Frα)-targeting antibody-drug conjugate (ADC), with pembrolizumab in platinum-resistant ovariancancer (PROC): Initial results of an expansion cohort from FORWARD II, a Phase Ib study. Ann Oncol (2018) 29 Suppl_8, Abstract 949P, Poster |