Sesen Bio (Formally Eleven Biotherapeutics)
Reports Positive, Three-Month Data from VISTA Trial of Vicinium™ in
High-Grade NMIBC
Data Presented During Plenary Session at
American Urological Association Annual Meeting
Company to Host Conference Call Today at 4:05
p.m. ET
Sesen Bio, Inc. (NASDAQ: SESN), a late-stage clinical company
advancing next-generation antibody-drug conjugate (ADC) therapies
for the treatment of cancer, today announced positive, three-month
data from its ongoing Phase 3 VISTA Trial of Vicinium™ for the
treatment of patients with high-grade non-muscle invasive bladder
cancer (NMIBC) who have been previously treated with bacillus
Calmette-Guérin (BCG). The efficacy data being reported are based
on three-month follow-ups from 111 patients with high-grade NMIBC
that is either carcinoma in situ (CIS), which is cancer found on
the inner lining of the bladder that has not spread into muscle or
other tissue, with or without papillary disease, or from patients
with papillary disease without CIS, which is cancer that has grown
from the bladder lining out into the bladder, but has not spread
into muscle or other tissue.
“High-grade NMIBC is a devastating cancer that typically occurs
later in life and for which treatment options are limited. Over the
last 30 years, our industry has seen little innovation for the
treatment of this prevalent cancer. The current standard-of-care,
BCG, works in many patients, but many will also eventually relapse.
For those patients who relapse or who don’t respond at all, the
standard alternative is radical cystectomy. In a cystectomy, the
bladder is removed along with surrounding lymph nodes and other
organs that contain cancer. I am very encouraged by both the safety
and these three-month efficacy data with Vicinium, and I look
forward to continuing to work with the Sesen Bio team to help bring
forward this potential treatment as a safe and effective option for
my patients,” said Rian Dickstein, M.D. F.A.C.S., chief of urology,
University of Maryland Baltimore Washington Medical Center; medical
director of GU oncology, Tate Cancer Center at The University of
Maryland Baltimore Washington Medical Center; clinical assistant
professor, Department of Surgery, University of Maryland School of
Medicine; director, bladder cancer program, Chesapeake Urology; and
an investigator in the VISTA Trial.
“The VISTA Trial three-month data are encouraging for our
company and the patients with high-grade NMIBC who have been
underserved for many years,” said Stephen Hurly, president and
chief executive officer of Sesen Bio. “We have made tremendous
progress over the last several years to get us to where we are
today, and I am proud of what our team has accomplished. Our new
name is a reflection of the journey we’ve taken to get to this
point and represents our mission of improving lives. With 12-month
data expected by mid-2019, we are continuing to advance Vicinium to
assess its full potential in treating this devastating cancer.”
VISTA Trial Design and Patient CohortsThe Phase 3 VISTA
Trial completed recruitment in March 2018 with a total of 133
patients with high-grade NMIBC that is either CIS or papillary with
or without CIS, who have been previously treated with BCG. The
primary endpoint of the trial is the complete response rate in
patients with CIS with or without papillary disease.
The clinical trial includes three patient cohorts based on
histology and time to recurrence after adequate BCG:
- Cohort 1 (n=87): patients with CIS with
or without papillary disease whose cancer recurred within six
months of their last course of BCG treatment.
- Cohort 2 (n=6): patients with CIS with
or without papillary disease whose cancer recurred after six
months, but before 11 months, after their last course of BCG
treatment.
- Cohort 3 (n=40): patients with
papillary disease without CIS whose cancer recurred within six
months of their last course of BCG treatment.
Three-Month Efficacy Results: CIS PatientsIn cohort 1, 72
patients were evaluable for three-month data as of the April 20,
2018 data cut-off date. In these patients, treatment with Vicinium
demonstrated a complete response rate of 39 percent. In evaluable
patients in cohort 2 (n=5), treatment with Vicinium demonstrated a
complete response rate of 80 percent. In an analysis assessing
pooled CIS patients from cohorts 1 and 2 (n=77), based on final
U.S. Food and Drug Administration guidance on treatment of
BCG-unresponsive CIS NMIBC patients (defined as patients with
recurrent CIS within 12 months of adequate BCG therapy)1, Vicinium
treatment resulted in a complete response rate of 42 percent at
three months.
Three-Month Efficacy Results: Papillary PatientsPatients
with papillary disease without CIS were enrolled in cohort 3, but
are not included in the primary endpoint assessment. At screening,
all of these patients underwent mandatory resection of their tumors
and upon starting treatment, were deemed to have no visible
evidence of disease. As such, in this patient population, rates of
disease recurrence and time to disease recurrence are standard
criteria to evaluate response. In these evaluable patients (n=34),
treatment with Vicinium demonstrated a 68 percent recurrence-free
rate at three months.
Preliminary Safety ResultsTo date, Vicinium has been
well-tolerated in the VISTA Trial. In treated patients across
cohorts (n=129), 72 percent of all adverse events were Grade 1 or
2. The most commonly reported treatment-emergent adverse events
(all grades) were urinary tract infection (29%), dysuria (19%),
hematuria (16%), pollakiuria (12%), diarrhea (10%), fatigue (10%),
micronutrition urgency (9%), nausea (8%) and increased lipase (8%,
all asymptomatic). Of the treatment-related adverse events, four
percent were Grade 3 or 4, with no Grade 5 treatment-related
adverse events. Four treatment-related serious adverse events were
reported, including acute kidney injury or renal failure and
cholestatic hepatitis.
“The positive, three-month data from the VISTA Trial support
Vicinium’s potential to offer a new and completely different
treatment option for patients who need it,” said Donald L. Lamm,
M.D., BCG Oncology, P.C., Phoenix. “In contrast to the many other
advances in cancer therapy, treatment for high-grade NMIBC has
suffered from little innovation, and Vicinium represents a unique
approach with a targeted protein, an entirely new mechanism for
treating this disease. I believe this new treatment approach, which
has demonstrated a 42 percent, three-month complete response rate
in patients who have failed to respond to BCG and good
tolerability, gives these patients new hope for beating bladder
cancer without life-changing major surgery. High-grade NMIBC
patients have a high chance of losing their bladder after having
gone through unreliable and often difficult treatments. I believe
that Vicinium, a first-in-class, innovative therapy, may change
that in the future.”
Conference Call InformationTo participate in the
conference call, please dial (844) 831-3025 (domestic) or (315)
625-6887 (international) and refer to conference ID 4453267. The
webcast can be accessed in the Investor Relations section of the
company's website at www.sesenbio.com. The replay of the webcast
will be available in the investor section of the company’s website
at www.sesenbio.com for 60 days following the call.
About the VISTA Clinical TrialThe VISTA Trial is an
open-label, multicenter, single-arm Phase 3 clinical trial
evaluating the efficacy and tolerability of Vicinium™ in patients
with high-grade non-muscle invasive bladder cancer (NMIBC) that is
carcinoma in situ (CIS), which is cancer found on the inner lining
of the bladder that has not spread into muscle or other tissue)
and/or papillary, which is cancer that has grown from the bladder
lining out into the bladder but has not spread into muscle or other
tissue, who have been previously treated with bacillus
Calmette-Guérin (BCG). The primary endpoint of the trial is the
complete response rate in patients with CIS with or without
papillary disease. Patients in the trial receive locally
administered Vicinium twice a week for six weeks, followed by
once-weekly treatment for another six weeks, then treatment every
other week for up to two years. Twelve-month data are anticipated
in mid-2019. To learn more about the Phase 3 VISTA Trial, please
visit www.clinicaltrials.gov and search the
identifier NCT02449239.
About Vicinium™Vicinium™, also known as VB4-845, is Sesen
Bio’s lead product candidate and is a next-generation antibody-drug
conjugate (ADC), developed using the company’s proprietary Targeted
Protein Therapeutics platform, for the treatment of high-grade
non-muscle invasive bladder cancer (NMIBC). Vicinium 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 (ETA).
Vicinium is constructed with a stable, genetically engineered
peptide linker 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 Vicinium for the treatment of high-grade NMIBC in
patients who have previously received two courses of bacillus
Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive.
Twelve-month data from the trial are anticipated in mid-2019.
Additionally, Sesen Bio believes that Vicinium’s cancer
cell-killing properties promote an anti-tumor immune response that
may potentially combine well with immuno-oncology drugs, such as
checkpoint inhibitors. The activity of Vicinium 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 CancerBladder 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 BioSesen Bio, Inc. is a late-stage clinical
company advancing next-generation antibody-drug conjugate therapies
for the treatment of cancer based on the company’s Targeted Protein
Therapeutics platform. The company’s lead program, Vicinium™, also
known as VB4-845, is currently in a Phase 3 registration trial, the
VISTA Trial, for the treatment of high-grade non-muscle invasive
bladder cancer. Twelve-month data from the trial are anticipated in
mid-2019. Vicinium incorporates a tumor-targeting antibody fragment
and a protein cytotoxic payload into a single protein molecule
designed to selectively and effectively kill cancer cells while
sparing healthy cells. For more information, please visit the
company’s website at www.sesenbio.com.
Cautionary Note on Forward-Looking StatementsAny
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
uncertainties inherent in the initiation and conduct of clinical
trials, the possibility that the three-month data of the Phase 3
VISTA Trial are not indicative of final clinical results and final
clinical trial results may not be positive with regard to the
safety or efficacy of Vicinium, our ability to successfully develop
our product candidates and complete our planned clinical programs,
our ability to obtain marketing approvals for our product
candidates, expectations regarding our ongoing clinical trials,
availability and timing of data from clinical trials, whether
interim results from a clinical trial will be predictive of the
final results of the trial or results of early clinical studies
will be indicative of the results of future studies, the adequacy
of any clinical models, expectations regarding regulatory approvals
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.
1 United States Food and Drug Administration, BCG-Unresponsive
Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics
for Treatment Guidance for Industry, February 2018
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version on businesswire.com: https://www.businesswire.com/news/home/20180521005913/en/
THRUST Strategic CommunicationsMonique Allaire,
617-895-9511monique@thrustir.comorAlicia Davis,
910-620-3302alicia@thrustir.com
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