Sesen Bio Announces Positive Cost-Effectiveness Profile for Vicineum™ Based on the Final Evidence Report Issued by the Institute for Clinical and Economic Review (ICER)

Rhea-AI Summary

Sesen Bio (Nasdaq: SESN) announced positive findings regarding the cost-effectiveness of Vicineum based on an independent analysis by ICER. The report indicates that Vicineum demonstrates superior health benefits for patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) compared to best supportive care. Estimated costs per patient in the first year are approximately $123,000, leading to a projected cumulative healthcare cost reduction of about $101,000 by year five. The company aims to submit its Biologics License Application for Vicineum to the FDA soon.

Positive

• ICER report finds Vicineum to be cost-effective for treating BCG-unresponsive NMIBC.
• Demonstrated superior Complete Response and Recurrence-Free Survival rates compared to historical data.
• Projected cumulative healthcare cost reduction of approximately $101,000 by year five.

Negative

• None.

Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced 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.

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: https://icer.org/wp-content/uploads/2020/08/ICER_Bladder_Cancer_Final_Report_121720.pdf

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.

About Sesen Bio

Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer. The Company’s lead program, Vicineum™, also known as VB4-845, is currently in a Phase 3 registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In December 2019, the Company initiated the BLA submission for Vicineum to the FDA under Rolling Review. Vicineum is a locally administered targeted fusion protein composed of an anti-EpCAM antibody fragment tethered to a trunc

FAQ

What are the findings of the ICER report on SESN's Vicineum?

The ICER report indicates Vicineum shows cost-effectiveness, with better health benefits for patients with BCG-unresponsive NMIBC compared to best supportive care.

When will Sesen Bio submit its Biologics License Application for Vicineum?

Sesen Bio plans to complete and submit its Biologics License Application for Vicineum to the FDA shortly.

What is the estimated cost impact of Vicineum according to the ICER report?

The ICER report estimates an additional cost of approximately $123,000 in the first year per patient, with a cumulative reduction of about $101,000 in healthcare costs by year five.

How does Vicineum perform compared to historical treatment data?

Vicineum demonstrates Complete Response and Recurrence-Free Survival rates that exceed expectations based on historical data.

Who conducted the cost-effectiveness analysis for Vicineum?

The analysis was conducted by the Institute for Clinical and Economic Review (ICER), a leading Health Technology Assessment body in the U.S.