IMNN-001 Immunotherapy Has Survival Benefits in Ovarian Cancer

Patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer experienced survival benefits following treatment with the immunotherapy IMNN-001, according to interim data that was recently released.

Participants in the intent-to-treat population from the phase 1/2 OVATION 2 trial saw a progression-free survival (PFS, the time following treatment where a patient’s disease does not spread or worsen) improvement by approximately 33% when treated with IMNN-001 (immunotherapy) and neoadjuvant chemotherapy versus a control group treated with standalone neoadjuvant chemotherapy (NACT), according to a press release from IMUNON, the clinical-stage biotechnology company behind the drug.

Likewise, treatment with IMNN-001 resulted in an improvement in overall survival (OS, the time following treatment that a patient is still alive) of approximately nine months when compared to the control group, IMUNON reported.

Read more: Optimism Abounds in Ovarian Cancer Research

A subgroup analysis of patients who also received maintenance therapy via a PARP inhibitor (PARPi) demonstrated that this patient population saw greater PFS and OS when treated with IMNN-01 and NACT as well as a PARPi. The median PFS for patients treated with PARPi, IMNN-001 and NACT was 23.7 months, compared with 15.7 months after treatment without IMM-001. Median OS for the PARPi and NACT group was 45.6 months and has not been reached for the group also treated with IMNN-001, according to the release.

A phase 1/2 randomized, open-label, multicenter study, OVATION 2 began in 2018 and is estimated to be completed by the end of 2024, according to its listing on clinicaltrials.gov.

The study reached its full enrollment of 110 patients in September 2022, IMUNON reported, also stating that a full readout of data from the study is expected in mid-2024.

The American Cancer Society estimated that there will be approximately 19,710 new diagnoses of ovarian cancer and 13,270 deaths from ovarian cancer in 2023 and explained that primary peritoneal carcinoma and fallopian tube cancer are both rare cancers that are similar to ovarian cancer and typically have common treatment strategies.

Epithelial ovarian tumors, the American Cancer Society described, start in the outer surface of the ovaries, and approximately 85% to 90% of malignant ovarian cancers are epithelial ovarian carcinoma.

Other early data included a 20% higher score of R0 tumor resection — “a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed” — and a doubled CRS chemotherapy response score, IMUNON reported, also noting that safety analyses showed “good tolerability of IMNN-001 in this setting.”

“We are encouraged by these interim results and are particularly intrigued by the overall survival trends in the subgroup of patients who received PARP inhibitors, neoadjuvant chemotherapy and IMNN-001,” Dr. Corinne Le Goff, IMUNON’s president and chief executive officer, said in the news release. “While the number of patients in this subgroup is relatively small, this regimen may hold potential in treatment strategies as we continue to monitor patients enrolled in OVATION 2.”

IMNN-001, IMUNON explained in the release, “is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation.”

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