Complete Response Rates from All Four Time
Points in Carcinoma in Situ Patients In-line with Phase 2 Data
Company to Host Conference Call Today, January
3, at 8:30 a.m. ET
Sesen Bio, Inc. (Nasdaq: SESN), a late-stage clinical company
advancing targeted fusion protein therapeutics for the treatment of
cancer, today reported positive preliminary efficacy data for the
primary endpoint of its ongoing Phase 3 registration trial, the
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) and deemed
BCG-unresponsive. The data reported show clinically meaningful
complete response rates in evaluable Carcinoma in situ patients at
three, six, nine and 12 months of follow-up in the trial consistent
with the data in the completed Phase 1 and Phase 2 clinical trials.
Importantly, Vicinium continues to be generally well-tolerated in
treated patients.
“Non-muscle invasive bladder cancer is a very prevalent cancer
that can progress to become incurable. The usual treatment for
patients who relapse or become refractory to BCG, today’s
standard-of-care, is complete bladder removal or radical
cystectomy,” said Michael A.S. Jewett, M.D., Professor of Surgery,
Division of Urology, University of Toronto. “Removing the bladder
is a potentially morbid and complex surgery with potential for side
effects that can drastically reduce a patient’s quality of life. In
fact, many patients choose not to undergo bladder removal. I am
very encouraged by the data generated to-date with intravesical
Vicinium as an alternative after BCG failure. Based on the strength
of the clinical activity observed, and the consistently favorable
safety and tolerability, I believe that Vicinium has the potential
to change the treatment outcome for patients.”
VISTA Trial DesignThe Phase 3 VISTA Trial is a
single-arm, multi-center clinical trial designed to support the
approval of Vicinium for the treatment of patients with high-grade,
BCG-unresponsive NMIBC. The trial enrolled a total of 133 patients
across three cohorts based on histology and time to disease
recurrence after adequate BCG:
- Cohort 1 (n=86): Carcinoma in situ
patients with or without papillary disease whose cancer was
determined to be refractory or recurred within six months of their
last course of adequate BCG
- Cohort 2 (n=7): Carcinoma in situ
patients with or without papillary disease whose cancer was
determined to be refractory or recurred after six months, but less
than 12 months, after their last course of adequate BCG
- Cohort 3 (n=40): patients with
papillary disease without Carcinoma in situ whose cancer was
determined to be refractory or recurred within six months of their
last course of adequate BCG
The data reported build upon preliminary three-month data
presented from a subset of patients in May 2018 and are for the
primary endpoint of the VISTA Trial, which is the complete response
rate and duration of response in patients in Cohort 1. The company
also reported data from Cohort 2, separately and pooled with Cohort
1, based on final U.S. Food and Drug Administration guidance on
treatment of BCG-unresponsive Carcinoma in situ patients (defined
as patients with recurrent Carcinoma in situ within 12 months of
adequate BCG therapy)1.
The patient population in Cohort 3 represents an opportunity for
future label expansion, and the company plans to report efficacy
data from this cohort, as well as the secondary endpoints in the
VISTA Trial, in mid-2019.
Preliminary Efficacy Results in Carcinoma in situ
Patients
Cohort 1 (n=86)
Time point Evaluable Patients
Complete Response Rate (95% Confidence
Interval) 3-months n=86
37% (27%, 48%) 6-months
n=85 25% (16%, 35%) 9-months
n=84 18% (10%,
28%) 12-months n=81
14% (7%, 23%)
Cohort 2 (n=7)
Time point Evaluable Patients
Complete Response Rate (95% Confidence
Interval) 3-months n=7
57% (18%, 90%) 6-months
n=7 57% (18%, 90%) 9-months
n=7 43% (10%, 82%)
12-months n=7
14% (0%, 58%)
Pooled Cohorts 1 and 2 (n=93)
Time point Evaluable Patients
Complete Response Rate (95% Confidence
Interval) 3-months n=93
39% (29%, 49%) 6-months
n=92 27% (18%, 37%) 9-months
n=91 20% (12%,
29%) 12-months n=88
14% (7%, 23%)
Notably, the interim Phase 3 complete response rates in pooled
patients from Cohorts 1 and 2 are in-line with the complete
response rates in pooled patients in the completed Phase 2 clinical
trial.
Preliminary Phase 3 CRR vs Phase 2
CRR
Time point Phase 3 Pooled CRR
(95% Confidence Intervals)
Phase 2 Pooled CRR
(95% Confidence Interval)
3-months 39% (29%, 49%)
40% (26%, 56%) 6-months
27% (18%, 37%) 27% (15%, 42%) 9-months
20% (12%, 29%)
18% (8%, 32%) 12-months 14% (7%,
23%) 16% (7%, 30%)
The company also reported an update on the durability of
responses in the VISTA Trial. While the median has not yet been
reached, the preliminary data show that Vicinium treatment resulted
in a prolonged duration of response in many patients. This is
particularly notable given that, in order for patients to remain on
study, they have to have achieved a complete response at each
assessment time period. These findings suggest that Vicinium has
the potential to benefit patients by delaying the time to a radical
cystectomy, a secondary endpoint that will be measured and reported
in mid-2019.
Preliminary Safety ResultsVicinium continues to be
well-tolerated by patients treated in the VISTA Trial. As of the
December 3, 2018 data cut off, in patients across all three cohorts
(n=133), 78 percent of adverse events were Grade 1 or 2. The most
commonly reported treatment-related adverse events were dysuria
(13%), hematuria (12%) and urinary tract infection (11%) – all of
which are consistent with the profile of bladder cancer patients
and the use of catheterization for treatment delivery. These
adverse events were determined to be manageable and reversible, and
only five patients discontinued treatment due to an adverse event.
Serious adverse events, regardless of treatment attribution, were
reported in 14 percent of patients. There were four
treatment-related SAEs reported in three patients including acute
renal injury (Grade 3), pyrexia (Grade 2), cholestatic hepatitis
(Grade 4) and renal failure (Grade 5).
“We are very pleased with these preliminary data, which are
consistent with the data in our completed Phase 2 clinical trial of
Vicinium for the treatment of high-grade NMIBC, and further support
our belief that Vicinium has the potential to change how patients
are treated after BCG,” said Dr. Thomas Cannell, president and
chief executive officer of Sesen Bio. “The design of the VISTA
Trial aligns with FDA’s guidance for NMIBC drug development, and
the findings are highly encouraging, demonstrating that treatment
with Vicinium results in clinically meaningful efficacy and
favorable safety and tolerability. Overall, the data reinforce our
belief that Vicinium is positioned to provide a valuable benefit to
patients by treating their disease with long-term responses and
extending their time to face such a decision as removing their
bladder. 2019 is set to be a transformational year for Sesen Bio,
and we look forward to advancing the VISTA Trial and assessing the
full 12-month data from all patients later this year.”
The VISTA Trial completed enrollment in the second quarter of
2018, and complete 12-month efficacy data from all patients in the
clinical trial are expected to be reported at a medical meeting in
mid-2019.
Conference Call InformationTo participate in the
conference call, please dial (844) 831-3025 (domestic) or (315)
625-6887 (international) and refer to conference ID 4263106. 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, 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 Carcinoma in situ 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 from all patients
in the VISTA Trial 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®, a locally-administered
fusion protein, is Sesen Bio’s lead product candidate being
developed 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 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
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. Complete 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 targeted fusion protein therapeutics for the
treatment of cancer. 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, BCG-unresponsive
non-muscle invasive bladder cancer. Twelve-month data from all
patients in the VISTA 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 available preliminary data of the
Phase 3 VISTA Trial are not indicative of final data from all
patients in Phase 3 VISTA Trial and final data 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, 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/20190103005202/en/
Monique Allaire, THRUST Strategic
Communicationsmonique@thrustsc.com617-895-9511
Chelcie Lister, THRUST Strategic
Communicationschelcie@thrustsc.com910-777-3049
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