A Phase 1b/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Mirvetuximab Soravtansine (IMGN853) in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab+Carboplatin in Adults With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

Trial ID #	NCT02606305; FORWARD II
Phase	Ib/II
Drug Class	Angiogenesis Inhibitors: VEGF
Drug Name	Bevacizumab
Alternate Drug Names	immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin
Drugs in Trial	Bevacizumab, Carboplatin, Mirvetuximab soravtansine
Eligible Participant	Platinum sensitive FRalpha+ ovarian cancer; IHC: ≥ 25% tumor cells at ≥ 2+ intensity (Mir+CarboPt), IHC: ≥ 50% of tumor cells at 2+ intensity (Mir+CarboPt+Bev)
Patients Enrolled	200 [Mir+CarboPt: 18; median 2.5 prior therapies (1-6); Mir+CarboPt+Bev: 41, median 1 prior therapy (1-2 prior)]
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DoR, PFS, RP2D, evaluated per RECIST
Biomarkers	FRalpha protein
Efficacy	Mir+CarboPt: ORR: 71% (3CR, 9PR, n=17) PFS: 15 months (9.9-NR) Mir+CarboPt+Bev: ORR: 83% (9CR, 25PR) DoR: 10.9 months PFS: 13.5 months Exploratory analysis, 1 prior therapy: Mir+CarboPt+Bev: ORR: 90% (6CR, 22PR, n=31) DoR: 9.7 months PFS: 11.9 months
Clinically Significant Adverse Events	Dose limiting toxicities: vasculitis (grade 3) Serious AE: none Grade 3-4 AE: Mir+CarboPt: neutropenia (28%), thrombocytopenia (17%), anemia (11%), hypokalemia (11%); Mir+CarboPt+Bev: thrombocytopenia (51%); neutropenia (39%); hypertension (10%), grade 2 peripheral neuropathy (22%)
Conclusion	Encouraging activity in FRalpha+ patients
Reference	Moore KN et al. Safety and activity findings from a phase Ib escalation study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin in patients with platinum-sensitive ovarian cancer. Gynecol Oncol (2018) 151: 46-52 https://www.ncbi.nlm.nih.gov/pubmed/30093227 O'Malley D et al. Mirvetuximab soravtansine (MIRV), a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with carboplatin (CARBO) and bevacizumab (BEV): Final results from a study in patients (pts) with recurrent platinum sensitive ovarian cancer. Annals Oncol (2020) 31 (suppl_4) abstract 833P https://www.clearityfoundation.org/wp-content/uploads/2020/10/Mirv-and-CarboPt-and-Bev-ESMO-2020-abstract.pdf Richardson DL et al. Phase 1b study of mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate, in combination with carboplatin and bevacizumab in patients with platinum-sensitive ovarian cancer. Gynecol Oncol (2024) 185:186-193 https://pubmed.ncbi.nlm.nih.gov/38447347/

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