| Trial ID # | NCT04625270: RAMP 201 |
| Phase | II |
| Drug Class | Signaling Pathway Inhibitors: Integrins-FAK/FAK |
| Drug Name | Defactinib |
| Alternate Drug Names | VS-6063, PF-04554878 |
| Drugs in Trial | Avutometinib, Defactinib |
| Eligible Participant | Recurrent low grade serous ovarian cancer |
| Patients Enrolled | 62 patients; Avu: 33, median 3 prior therapies (1-10); Avu+Def: 31, median 4 prior therapies (1-11) |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Randomized |
| Endpoints | ORR, DCR, evaluated per RECIST |
| Efficacy | Results from PART A: ORR: 45 (13PR, n=29) vs 10% (1CR, 2PR, n=30) KRAS MUT: Avu+Def (n=15) vs Avu (n=15): KRAS WT: Avu+Def (n=14) vs Avu (n=16): |
| Clinically Significant Adverse Events | Serious AE: |
| Conclusion | The combination of avutometinib with defactinib yields encouraging response rates with a well tolerated safety profile in women with heavily pretreated recurrent LGSOC regardless of KRAS status and with prior MEK inhibitor treatment |
| Reference | Banerjee SN et al. Initial efficacy and safety results from ENGOT-ov60/GOG-3052/RAMP 201: A phase 2 study of avutometinib (VS-6766) ± defactinib in recurrent low-grade serous ovarian cancer (LGSOC). J Clin Oncol 41, 2023 (suppl 16; abstr 5515) Banerjee SN et al. Poster Banerjee S et al. Avutometinib plus defactinib in recurrent low-grade serous ovarian cancer: A subgroup analysis of ENGOT-OV60/GOG3052/RAMP 201 Part A. SGO (2024) |