IMMN-001 Shows Efficacy in Ovarian Cancer: OVATION-2 Trial Update
Premal Thaker, MD, MS, discusses important implications and takeaways of the phase 1/2 OVATION study of IMMN-1 in addition to chemotherapy for the treatment of newly diagnosed epithelial ovarian cancer.
In an interview with Targeted OncologyTM, Premal Thaker, MD, MS, gynecologic oncologist at Siteman Cancer Center, Washington University in St. Louis, discusses data from the phase 1/2 OVATION-2 trial (NCT03393884) exploring IMMN-1 added to to neoadjuvant and adjuvant chemotherapy for the treatment of newly diagnosed epithelial ovarian cancer.
Data showed that at a median follow-up of 24 months, patients in the intention-to-treat (ITT) population given IMNN-001 plus chemotherapy (n = 59) achieved a median PFS of 14.9 months (95% CI, 12.55-21.19) compared with 11.9 months (95% CI, 10.09-14.92) in patients treated with chemotherapy alone (n = 54; HR, 0.79; 95% CI, 0.51-1.23).
At 24 months of follow-up, the median OS was 40.5 months (95% CI, 28.09-not evaluable [NE]) in the IMNN-001 arm vs 29.4 months (95% CI, 24.94-45.60) in the chemotherapy arm (HR, 0.74; 95% CI, 0.42-1.30; P =.2963). With follow-up extended to 31 months, the median OS was 46.0 months (95% CI, 39.20-NE) and 33.0 months (95% CI, 27.14-NE), respectively (HR, 0.69; 95% CI, 0.40-1.19; P =.1865).
According to Thaker, the efficacy truly stands on its own, marking significant progress in drug development.
Additionally, a crucial aspect learned from these trials is how to better support patients in receiving their medications, says Thaker. For instance, with intraperitoneal administration, which can be challenging due to adverse effects like abdominal pain, clinicians now employ prophylactic pain control and anxiety medication.
A notable positive with this immunotherapy is the absence of cytokine release syndromes or other severe adverse effects previously associated with agents like interleukin-12, which was abandoned due to its toxicity profile. This intraperitoneal therapy avoids such issues while broadly engaging both the adaptive and innate immune systems.
Thaker says it's important to note that this treatment is impacting a much larger component of the immune system, involving not just T cells or NK cells, but also macrophages and other elements.
