Imunon Inc (NASDAQ:IMNN) announces interim progression-free survival (PFS) and overall survival (OS) data with IMNN-001 in its Phase 1/2 OVATION 2 Study of intraperitoneal IMNN-001 in combination with neoadjuvant chemotherapy (NACT) for newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.
Interim data from the intent-to-treat (ITT) population demonstrated a delay in disease progression in the treatment arm of approximately 33% compared with the control arm.
Preliminary OS data follows a similar trend, showing an approximate 9-month improvement in the treatment arm over the control arm.
Subgroup analyses show that patients treated with a PARP inhibitor (PARPi) as maintenance therapy had longer PFS and OS if they were also treated with IMNN-001 than patients treated with NACT only.
The median PFS in the PARPi + NACT group and the PARPi + NACT + IMNN-001 group was 15.7 months and 23.7 months, respectively.
The median OS in the PARPi + NACT group was 45.6 months and has not yet been reached in the PARPi + NACT + IMNN-001 group.
IMUNON also sees benefits in other secondary endpoints, including an approximately 20% higher R0 tumor resection score and a doubling of the CRS 3 chemotherapy response score to approximately 30% in the treatment arm versus 14% in the control arm.
Safety analyses continue to show good tolerability of IMNN-001 in this setting.
The final readout of this study is expected by mid-2024.
Price Action: IMNN shares are down 6.62% at $0.95 on the last check Thursday.
