SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the
“Company”), a late-stage clinical biopharmaceutical company focused
on the development of novel therapies for a broad range of cancer
indications, today announced confirmatory top-line clinical data
from the final analysis of results from its Phase 1/2 clinical
trial of galinpepimut-S (GPS), the Company’s Wilms Tumor-1
(WT1)-targeting peptide immunotherapeutic, in combination with
Merck’s anti-PD-1 therapy, pembrolizumab (KEYTRUDA®), in patients
diagnosed with WT1(+) relapsed or refractory platinum-resistant
advanced metastatic ovarian cancer.
Data from 17 patients enrolled in the study,
conducted under a Clinical Trial Collaboration and Supply Agreement
with Merck & Co., Inc., Rahway, N.J., USA (known as MSD outside
the United States and Canada), have undergone final analysis for
safety and efficacy. All enrolled patients were resistant to
standard of care platinum-based therapy and 76.5 percent (13/17) of
the patients were refractory to or had failed their first- or
second-line therapies, with 23.5 percent (4/17) having failed three
or more lines of therapy, including one patient (5.9 percent) who
failed five previous lines of therapy. Of the 17 patients, 16
received at least three doses of GPS and had follow-up
cross-sectional imaging (CT/MRI) to determine tumor status.
Summary of Top-Line Overall Survival and Progression-Free
Survival Data:
- Median Overall
Survival (OS) was 18.4 months compared to 13.8 months in a
checkpoint inhibitor single agent study in a similar patient
population treated with checkpoint inhibitor alone
- Median
Progression-Free Survival (PFS) was 12 weeks compared to eight
weeks in a checkpoint inhibitor single agent study in a similar
patient population treated with checkpoint inhibitor alone
- The overall response
rate (ORR) of the trial is 6.3 percent with a disease control rate
(DCR), which is the sum of overall response rate and rate of stable
disease, of 50.1 percent at a median follow-up of 14.4 months. In a
checkpoint inhibitor single agent study in a similar
platinum-resistant ovarian cancer patient population treated with a
checkpoint inhibitor alone, the observed DCR was 37.2 percent,
consistent with a DCR rate increase of approximately 45 percent in
the GPS combination with Keytruda over that seen for checkpoint
inhibitors alone.
Importantly, survival and disease control benefits were observed
in patients harboring tumors with any level of detectable PD-L1
expression, i.e., those with Combined Positive Score (CPS) of one
or higher. The DCR is 63.6 percent in patients with a CPS of one or
higher in this study.
In the Phase 1/2 study, patients with a CPS score of less than
one showed a median OS of 3.2 months vs. patients with a CPS
greater than or equal to one who had a median OS of 18.4 months
and, as it relates to time to progression, patients with a CPS
score of less than one had a median PFS of 1.9 months and patients
with a CPS score of greater than or equal than one showed a median
PFS of 3.8 months.
In 16 evaluable patients in whom serial peripheral blood samples
were available, a correlation was observed between PFS and OS and
WT1-specific immune response after GPS vaccination across more than
one channel with intracellular cytokine flow-cytometry assays in
peripheral blood lymphocytes assaying reactivity against the four
pooled WT1 antigens comprising GPS. The data were consistent with
those seen in previous studies of GPS.
The safety profile of GPS in combination with pembrolizumab was
similar to pembrolizumab alone, with the only addition of
low-grade, rapidly resolving local reactions at the GPS injection
site, consistent with observations from other GPS clinical
studies.
“GPS has been primarily studied as maintenance therapy to
provide an overall survival benefit after patients reach a state of
minimal residual disease or complete remission. In contrast, in
this very difficult to treat patient population with relapsed or
refractory measurable advanced platinum-resistant ovarian cancer,
who underwent intensive chemotherapy with no apparent enduring
clinical benefit, the data suggests that the combination of GPS
plus pembrolizumab may be effective in stabilizing active disease.
We are excited that both the disease control rate and overall
survival results support our belief that GPS has the potential to
become an important therapeutic addition to a backbone of
checkpoint blockade for WT1(+) ovarian cancer patients, as well as
other WT1-expressing tumor types,” said Angelos Stergiou, MD, ScD
h.c., President and Chief Executive Officer of SELLAS. “SELLAS
plans to submit the full dataset at a major medical conference by
mid-next year. I would like to extend my sincere gratitude to all
patients who have participated in this clinical trial, as well as
the collective study teams at SELLAS and Merck,” concluded Dr.
Stergiou.
“What I find particularly important for patients with advanced
platinum-resistant ovarian cancer is that GPS appears to enhance
efficacy of checkpoint inhibitors in patients with tumors with
detectable PD-L1 expression, whilst demonstrating a low adverse
event burden. Until now, in immunotherapy-recalcitrant tumor types,
like ovarian cancer, the impression by many experts has been that
patients with CPS scores equal to or higher than 10 may be the most
probable candidates to derive clinically meaningful benefit from
checkpoint inhibitor therapy, either alone or in combination,“
stated Bruno Bastos, MD, Medical Oncologist and Study Investigator
at the Miami Cancer Institute, Physician Lead of the Multiple
Tumors/Phase 1 Clinic, and Assistant Professor at the Herbert
Wertheim College of Medicine. “Based on these results, it appears
that any ovarian cancer patient whose tumor expresses any level of
PD-L1, as long as this biomarker is detected, may benefit from the
addition of GPS to a checkpoint inhibitor regimen. If these data
are confirmed in larger studies in PD-L1+, WT1+ advanced ovarian
cancer, it could enable us to bring the benefits of immunotherapy
drugs to a broader patient population in a very difficult setting.
This is indeed exciting for the ovarian cancer field, as well as
patients suffering from other types of WT1+ malignancies,”
concluded Dr. Bastos.
About Ovarian Cancer Ovarian cancer is one
of the most common gynecologic malignancies and the fifth most
frequent cause of cancer death in women in the United States. Over
22,000 cases are diagnosed annually, and there are an estimated
15,500 deaths per year. The majority of patients have widespread
disease at presentation. The 5-year survival for advanced-stage
disease remains less than 30 percent. Combining GPS with the
checkpoint inhibitor pembrolizumab, which beneficially and
profoundly alters the tumor microenvironment (TME) is hypothesized
to increase the proportion of patients who develop an immune
response against their cancer and potentially improve their
clinical outcome over checkpoint inhibitors monotherapy, without
the burden of additional toxicities in macroscopically measurable
malignancies.
About SELLAS Life Sciences Group,
Inc. SELLAS Life Sciences Group, Inc. (NASDAQ: SLS)
is a late-stage clinical biopharmaceutical company focused on the
development of novel therapeutics for a broad range of cancer
indications. SELLAS’ lead product candidate, GPS, is licensed from
Memorial Sloan Kettering Cancer Center and targets the WT1 protein,
which is present in an array of tumor types. GPS has potential as a
monotherapy or in combination with other therapies to address a
broad spectrum of hematologic malignancies and solid tumor
indications. The Company is also developing GFH009, a small
molecule, highly selective CDK9 inhibitor, which is licensed from
GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and
diagnostic uses in the world outside of Greater China.
For more information on SELLAS, please
visit www.sellaslifesciences.com.
Keytruda® is a registered trademark of Merck Sharp &
Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
and is not a trademark of SELLAS. The manufacturer of this brand is
not affiliated with and does not endorse SELLAS or its
products.
Forward-Looking Statements This press
release contains forward-looking statements. All statements other
than statements of historical facts are “forward-looking
statements,” including those relating to future events. In some
cases, forward-looking statements can be identified by terminology
such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,”
“should,” “project,” “believe,” “estimate,” “predict,” “potential,”
“intend,” or “continue” and other words or terms of similar
meaning. These statements include, without limitation, statements
related to the further clinical development of GPS for ovarian
cancer, and the potential for GPS as a drug development candidate
for ovarian cancer patients. These forward-looking statements are
based on current plans, objectives, estimates, expectations, and
intentions, and inherently involve significant risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation, risks and uncertainties associated
with the COVID-19 pandemic and its impact on the Company’s clinical
plans, risks and uncertainties associated with immune-oncology
product development and clinical success thereof, the uncertainty
of regulatory approval, and other risks and uncertainties affecting
SELLAS and its development programs as set forth under the caption
“Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March
31, 2022 and in its other SEC filings. Other risks and
uncertainties of which SELLAS is not currently aware may also
affect SELLAS’ forward-looking statements and may cause actual
results and the timing of events to differ materially from those
anticipated. The forward-looking statements herein are made only as
of the date hereof. SELLAS undertakes no obligation to update or
supplement any forward-looking statements to reflect actual
results, new information, future events, changes in its
expectations or other circumstances that exist after the date as of
which the forward-looking statements were made.
Investor Contact Allison SossKCSA
Strategic
CommunicationsEmail: SELLAS@kcsa.com Phone:
212.896.1267
Media Contacts Raquel Cona / Michaela
FawcettKCSA Strategic
CommunicationsEmail: SELLAS@kcsa.com Phone:
212.896.1204
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