Imunon Inc (NASDAQ: IMNN) has released interim data from its Phase 1/2 OVATION 2 Study, presenting promising results for IMNN-001 in combination with neoadjuvant chemotherapy (NACT). The study focuses on newly diagnosed patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Interim Progression-Free Survival and Overall Survival Data
The interim data from the intent-to-treat (ITT) population shows a significant delay in disease progression in the treatment arm compared to the control arm, with approximately 33% improvement. Furthermore, preliminary overall survival (OS) data indicates an approximate 9-month improvement in the treatment arm over the control arm.
Improved Outcomes with IMNN-001 and PARP Inhibitors
Subgroup analyses demonstrate that patients treated with a PARP inhibitor (PARPi) as maintenance therapy had longer progression-free survival (PFS) and overall survival (OS) when also treated with IMNN-001, compared to patients treated with NACT alone. The median PFS for the PARPi + NACT + IMNN-001 group was 23.7 months, compared to 15.7 months for the PARPi + NACT group. Additionally, the median OS has not yet been reached in the PARPi + NACT + IMNN-001 group, while it was 45.6 months in the PARPi + NACT group.
Positive Secondary Endpoints and Safety Profile
IMUNON also observed positive outcomes in other secondary endpoints. The treatment arm showed a higher R0 tumor resection score, with approximately 20% improvement compared to the control arm. Additionally, the chemotherapy response score (CRS 3) doubled to approximately 30% in the treatment arm, compared to 14% in the control arm. Safety analyses revealed good tolerability of IMNN-001 in this setting.
Final Study Readout and Market Reaction
The final readout for the OVATION 2 Study is expected by mid-2024. Following the announcement of the interim data, IMNN shares experienced a 6.62% decrease and were trading at $0.95 at the time of reporting.