The majority
of the ICER Council (8 yes votes; 3 no votes) judged Vicineum as superior to best
supportive care
ICER report
estimates that treatment with Vicineum results in a decrease in
cumulative health care costs compared to usual care of
approximately $101,000 by year five
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 truncated form of
Pseudomonas Exotoxin A for the treatment of high-risk NMIBC. For
more information, please visit the company’s website at
www.sesenbio.com.
COVID-19 Pandemic Potential Impact
Sesen Bio continues to monitor the rapidly evolving environment
regarding the potential impact of the COVID-19 pandemic on our
Company. The Company has not yet experienced any disruptions to our
operations as a result of COVID-19, however, we are not able to
quantify or predict with certainty the overall scope of potential
impacts to our business, including, but not limited to, our ability
to raise capital and, if approved, commercialize Vicineum. Sesen
Bio remains committed to the health and safety of patients,
caregivers and employees.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for the Company, the Company’s strategy, future
operations, and other statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “will,” “would,”
“could,” “should,” “continue,” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: the Company’s
ability to successfully develop its product candidates and complete
its planned clinical programs, expectations regarding the
completion of the Company’s BLA submission for Vicineum,
expectations regarding the potential cost savings of Vicineum,
expectations regarding the safety and efficacy of Vicineum, and
other factors discussed in the “Risk Factors” section of the
Company’s Annual Report on Form 10-K, Quarterly Reports on Form
10-Q and other reports filed with the Securities and Exchange
Commission. In addition, the forward-looking statements included in
this press release represent the Company’s views as of the date
hereof. The Company anticipates that subsequent events and
developments will cause the Company’s views to change. However,
while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so. These forward-looking statements
should not be relied upon as representing the Company’s views as of
any date subsequent to the date hereof.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201218005072/en/
Erin Clark, Vice President, Corporate Strategy & Investor
Relations ir@sesenbio.com
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