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Premal H. Thaker, MD, MS, discusses the safety of intraperitoneal administration of IMNN-001 plus neoadjuvant chemotherapy in epithelial ovarian cancer.
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“Hopefully, as we continue to gain more knowledge, try to do larger trials with these prophylactic medications, we’ll be able to even maybe see better improvements, as well as get more medication into the patient.”
Premal H. Thaker, MD, MS, the David G. and Lynn Mutch Distinguished Professor of Obstetrics and Gynecology, director of Gynecological Oncology Clinical Research, and interim chief of the Division of Gynecologic Oncology at Siteman Cancer Center of Washington University in St. Louis, discussed the safety outcomes observed with intraperitoneal administration of the gene-mediated therapy IMNN-001 in combination with standard neoadjuvant chemotherapy for newly diagnosed, advanced epithelial ovarian cancer in the phase I/II OVATION-2 trial (NCT03393884). IMNN-001 is an interleukin-12 gene plasmid delivered via an amphiphilic polymer–based intraperitoneal platform intended to stimulate local immune responses within the peritoneal cavity.
According to Thaker, one of the primary safety considerations in the trial was the increased frequency of hematologic adverse effects (AEs) observed in the experimental arm. This finding was attributed, in part, to a higher frequency of laboratory monitoring in patients receiving weekly IMNN-001 dosing, leading to increased detection of cytopenias when compared with the standard-of-care chemotherapy arm. Notably, this suggests that the hematologic toxicity profile may have been influenced by the intensity of sampling rather than a direct pharmacologic effect alone, Thaker said.
Another observed AE of interest was abdominal pain, which appeared to be associated with the intraperitoneal route of administration. As the trial progressed, protocol modifications aimed at optimizing tolerability were introduced, resulting in improved management and drug delivery across more patients.
Despite the challenges related to abdominal discomfort and dose delivery, Thaker emphasized that many patients still had favorable responses even when they were unable to complete the full 17 planned doses of IMNN-001. Most patients tolerated 6 to 9 doses, which appeared sufficient to elicit measurable biologic activity, Thaker reported. This observation underscores the therapeutic potential of IMNN-001 even in the context of limited exposure and provides a rationale for further study of dose optimization and supportive strategies to improve tolerability, she highlighted.
Moving forward, Thaker noted that larger, confirmatory studies incorporating prophylactic interventions will be instrumental in expanding the therapeutic window of IMNN-001. Continued clinical evaluation is expected to clarify the relationship between dose intensity, immune activation, and long-term clinical benefit in this patient population
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