On July 25, 2016 Celsion Corporation (NASDAQ:CLSN) reported data from the second cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery (Press release, Celsion, JUL 25, 2016, View Source [SID:1234514019]). In the first six patients dosed, GEN-1 plus standard chemotherapy produced impressive results, with no dose limiting toxicities and highly promising efficacy signals in this difficult to treat cancer. Schedule your 30 min Free 1stOncology Demo! "The totality of study data available to date suggests that GEN-1 holds great potential to serve as an effective, safe IL-12 immunotherapy in ovarian cancer," said Dr. Premal Thaker, Associate Professor in Gynecologic Oncology, Washington University School of Medicine and OVATION Study Investigator. "Notably, we have seen dramatic decreases of 95% or greater in CA-125 protein levels, which serve as a key indicator of the presence of ovarian cancer cells, as well as impressive pathological response data, which is associated with prolonged survival. We look forward to the completion of this study, and to learning more about how GEN-1 performs in this patient population."
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The OVATION Study is designed to enroll three to six patients per dose cohort, and will continue into 2016 at higher doses of GEN-1 with the goal to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response. The first two cohorts each enrolled three patients. Enrollment in the third cohort is ongoing, and Celsion expects to complete the OVATION Study this year. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin and Doxil.
OVATION Study – Results to Date
Of the first six patients dosed, one patient demonstrated a complete response (CR), two patients demonstrated partial response (PR) and three patients demonstrated stable disease (SD), as measured by RECIST criteria.
Five patients had successful resections of their tumors, with two patients having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed and three patients with a R1 resection, indicating microscopic residual tumor. One patient in the second cohort is currently ineligible for debulking surgery due to a medical complication unrelated to the study or the study drug.
Of the five surgically treated and evaluable patients, one patient demonstrated a pathological complete response (pCR), two patients (40%) demonstrated a micro pathological response (microPR), and two patients (40%) demonstrated a macroPR. These data compare favorably to historical data, which indicate that pCRs are typically seen in less than 7% of patients receiving neoadjuvant chemotherapy followed by surgical resection. pCRs have been associated with a median overall survival of 72 months, which is more than three years longer than those who do not experience a pCR. In addition, microPRs are seen in approximately 30% of patients, and are associated with a median overall survival of 38 months&supl;.
"GEN-1 continues to demonstrate impressive activity in patients with advanced Stage III and IV ovarian cancer, a population clearly in need of effective therapies," said Nicholas Borys, M.D., Celsion’s chief medical officer. "We anticipate completion of enrollment in the third patient cohort in the coming weeks, and will continue to assess a potential accelerated clinical development path for GEN-1. In parallel, we are currently evaluating translational data from the study, which we expect to report before the end of the third quarter."