SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the
“Company”), a clinical-stage biopharmaceutical company focused on
the development of novel cancer immunotherapies for a broad range
of cancer indications, today announced final results from the
efficacy and safety data analysis of the prospective, randomized,
single-blinded, controlled Phase 2b independent
investigator-sponsored clinical trial of the combination of
trastuzumab (Herceptin®) +/- nelipepimut-S (NeuVax™, NPS) targeting
HER2 low-expressing breast cancer patient cohorts, including
triple-negative breast cancer (TNBC) patients, which were presented
at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium in San
Francisco, CA.
The comprehensive findings are based on the final analysis of
the full data-set from the clinical trial, and at a median
follow-up of 25.7 months from the time of randomization. In the
clinical trial, 275 patients were randomized to either placebo with
granulocyte-macrophage colony-stimulating factor (GM-CSF) (n=139)
or NPS with GM-CSF (n=136), while all received trastuzumab every 3
weeks for one year. No safety-related statistically
significant differences were seen between the treatment and control
arms in the rate of grade 1-3 adverse events of either local or
systemic nature, while no grade 4/5 toxicities were observed in
either arm. Also, there was no statistically significant difference
between the treatment arms in the cardiac ejection fraction
measured at baseline, as well as at four additional time-points up
to 24 months post-randomization.
In the intent-to-treat (ITT) population (all HER2 low-expressing
breast cancer patients; n=275), and over the 24-month
post-randomization follow-up period, the disease-free survival
(DFS) landmark rate was in favor of the combination (NPS plus
trastuzumab) arm (89.8%) versus trastuzumab alone (83.8%), as
shown in the graph below:
http://www.globenewswire.com/NewsRoom/AttachmentNg/ccf24548-915d-440e-b03b-f0524354342e
In the 97-patient TNBC cohort, the DFS landmark rate at 24
months for patients treated with NPS plus trastuzumab (n=53) was
92.6% compared to 70.2% for those treated with trastuzumab alone
(n=44), a clinically and statistically significant improvement, as
shown in the graph below:
http://www.globenewswire.com/NewsRoom/AttachmentNg/c69bc2d1-0741-482d-b11d-33aab2c2550c
In the TNBC cohort, there was a statistically significant
reduction of 71.9% (p=0.01) in the frequency of clinically detected
recurrences in those patients treated with the combination (NPS
plus trastuzumab) versus trastuzumab alone.
“This final analysis of the study database establishes a
clinically meaningful and statistically significant prolongation in
DFS, a validated surrogate marker of overall survival for TNBC - by
both hazard ratios and 24-month event rates - and a meaningful
decrease in the frequency of relapses identified by standard
clinical follow-up in favor of NPS plus trastuzumab given in the
adjuvant setting in TNBC patients,” commented Elizabeth A.
Mittendorf, MD, PhD, Rob and Karen Hale Distinguished Chair in
Surgical Oncology, Director of Research, Breast Surgical Oncology
Brigham and Women’s Hospital, Director, Breast Immuno-Oncology
Program Dana-Farber/Brigham and Women’s Cancer Center, and the
Principal Investigator of the Phase 2b study.
Nicholas J. Sarlis, MD, PhD, Executive Vice President and Chief
Medical Officer of SELLAS, further commented that “These definitive
results provide us with an enhanced understanding of the clinical
effect and safety profile of the combination therapy in this trial,
with positive efficacy outcomes being essentially confined to TNBC
patients, and continue to encourage us and support our ongoing
discussions with the U.S. Food and Drug Administration on the most
appropriate registration-enabling development path for NPS in
TNBC.”
The abstract text can be accessed at:
https://meetinglibrary.asco.org/record/170408/abstract.
Herceptin® is a registered trademark of Genentech, Inc. and is
not a trademark of SELLAS. The manufacturer of this brand is not
affiliated with and does not endorse SELLAS or its products.
About SELLAS Life Sciences Group, Inc.
SELLAS is a clinical-stage biopharmaceutical company focused on
novel cancer immunotherapeutics for a broad range of cancer
indications. SELLAS’ lead product candidate, galinpepimut-S (GPS),
is licensed from Memorial Sloan Kettering Cancer Center and targets
the Wilms Tumor 1 (WT1) protein, which is present in an array of
tumor types. GPS has potential as a monotherapy or in combination
to address a broad spectrum of hematologic malignancies and solid
tumor indications. SELLAS has a Phase 3 clinical trial planned
(pending funding availability) for GPS in acute myeloid leukemia
(AML) and is also studying GPS in combination with pembrolizumab in
multiple indications. SELLAS has received Orphan Drug designations
for GPS from the U.S. Food & Drug Administration (FDA) and the
European Medicines Agency (EMA) for AML, malignant pleural
mesothelioma (MPM), and multiple myeloma (MM); GPS has also
received Fast Track designation for AML, MPM and MM from the FDA.
SELLAS’ second product candidate, nelipepimut-S (NeuVax™, NPS), is
a HER2-directed cancer immunotherapy being investigated for the
prevention of the recurrence of breast cancer after standard of
care treatment in the adjuvant setting. NPS has received Fast Track
status designation by FDA for the treatment of patients with early
stage breast cancer with low to intermediate HER2 expression,
otherwise known as HER2 1+ or 2+, which includes triple negative
breast cancer (TNBC) patients, following standard of care.
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 results of clinical studies and as to further
development of NPS for breast cancer and interactions with the U.S.
Food and Drug Administration. 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 immune-oncology product development and clinical success
thereof, the uncertainty of regulatory approval, the uncertainty of
finding potential partners for product candidate development, and
other risks and uncertainties affecting SELLAS and its development
programs as set forth under the caption “Risk Factors” in Exhibit
99.1 in its Current Report on Form 8-K filed on July 18, 2018 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.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
Investor ContactsWill O’ConnorStern Investor
Relations, Inc.212-362-1200ir@sellaslife.com
David Moser, JDSELLAS Life Sciences
Group813-864-2571info@sellaslife.com
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