On December 18, 2020 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported favorable results for the cost-effectiveness of Vicineum based on an independent analysis issued by ICER in its final report published on December 17, 2020 (Press release, Sesen Bio, DEC 18, 2020, View Source [SID1234573078]).
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ICER is the leading Health Technology Assessment body in the United States, and is an independent non-profit, research organization that conducts assessments to examine the clinical and economic value of health care innovations such as prescription medications.
The final report used publicly available clinical data from the Company’s Phase 3 VISTA trial, and focused on adults with BCG-unresponsive, high-risk non-muscle invasive bladder cancer (NMIBC), including those with Carcinoma in situ, as well as those with high-risk Papillary (Ta/T1) disease.
The ICER report states that for many patients with NMIBC that is unresponsive to BCG, there are limited treatment options that are bladder preserving. As a potential treatment option for patients with NMIBC, the report describes Vicineum as demonstrating Complete Response and Recurrence-Free Survival rates that appear to be greater than would be expected, based on historical data, with few serious adverse events and low discontinuation rates.
The majority of the ICER Council (8 yes votes; 3 no votes) judged that the evidence was adequate to demonstrate that the net health benefit of Vicineum is superior to that of best supportive care.
The report estimates that treatment with Vicineum results in an additional per-patient cost of approximately $123,000 in year one — with net savings in the following years, leading to a decline in cumulative health care costs, compared to usual care, of approximately $101,000 by year five.
"We are very pleased with the final ICER report and found the entire process to be transparent, evidence-based and professional," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "The findings in the ICER report give us confidence in the value and cost-effectiveness of Vicineum. It is our goal to bring Vicineum to market to improve patient outcomes while reducing health care costs. The ICER report is very encouraging in that regard, and we look forward to working physicians, patients and payers to make that goal a reality."
The full report, including relevant disclaimers and assumptions, can be accessed at the following link: View Source
The Company is on track to complete and submit its Biologics License Application for Vicineum to the FDA by next week.
About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicineum for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.
About Non-Muscle Invasive Bladder Cancer
Bladder cancer is the sixth most commonly diagnosed cancer in the United States, and approximately 80 percent of patients have non-muscle invasive bladder cancer (NMIBC). In NMIBC, cancer cells are in the lining of the bladder or have grown into the lumen of the bladder but have not spread into muscle or other tissue. NMIBC primarily affects men and is associated with carcinogen exposure. Initial treatment includes surgical resection; however, there is a high rate of recurrence and more than 60 percent of all patients diagnosed with NMIBC will receive bacillus Calmette-Guérin (BCG) immunotherapy. While BCG is effective in many patients, challenges with tolerability have been observed and many patients will experience recurrence of disease. If BCG is not effective or a patient can longer receive BCG, the recommended option for treatment is radical cystectomy, the complete removal of the bladder.