Clinically and statistically significant efficacy
in the triple negative breast cancer cohort with a p-value of 0.013
and a 75.2% reduction in risk of relapse or death in favor of
investigational nelipepimut-S plus trastuzumab arm
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 data from the
prospective, randomized, single-blinded, controlled Phase 2b
independent investigator-sponsored clinical trial of the
combination of nelipepimut-S (NeuVax™, NPS) +/- trastuzumab
(Herceptin®) targeting HER2 low-expressing breast cancer patient
cohorts. The data were presented in an oral presentation at
the European Society for Medical Oncology (ESMO) 2018 Annual
Meeting, being held in Munich, Germany.
“These data presented at ESMO today highlight the therapeutic
potential of NPS for patients with early-stage triple negative
breast cancer (TNBC), who currently face limited and ineffective
treatment options in the adjuvant setting,” said Dr. Angelos
Stergiou, MD, ScD h.c., President and Chief Executive Officer of
SELLAS. “The combination of NPS and trastuzumab demonstrated a
clinically meaningful and statistically significant difference in
the cohort of patients with TNBC with a 75.2% reduction in risk of
relapse or death at 26 months. Importantly, following review
of the final data that were also assessed by the independent Data
Safety Monitoring Board (DSMB) on October 15, 2018, there was an
incremental further improvement of clinical benefit to patients now
observed in comparison with the data from the interim analysis
completed more than six months ago.”
The key data from today’s presentation, based on the final
analysis, are shown below, including the summary table and the
Kaplan-Meier (K-M) survival curve showing specifically the TNBC
cohort:
Safety: Most treatment-emergent adverse events (TEAEs) were of
mild or moderate (G1/2) severity (local: 98%; systemic: 93%). The
majority of G3 systemic TEAEs were unrelated to NPS.
Treatment-related adverse events consisted of manageable local
injection site reactions, skin induration, pruritus, and
fatigue.
Efficacy:Outcomes Summary (comparison between the 2-arms of the
study, i.e., Active: NPS + TZ, and Control: TZ alone):
Outcome Parameters |
ITT |
TNBC cohort |
No hormone Rx cohort |
N (both arms) |
275 |
97 |
110* |
Hazard ratio (HR) |
0.62 |
0.26 |
0.23 |
P-value |
.175 |
.013 |
.008 |
Risk reduction at 24 mo (%) |
37 |
75.2 |
75.9 |
24-mo DFS rate (Active) (%) |
89.8 |
92.6 |
93.2 |
24-mo DFS rate (Control) (%) |
83.8 |
70.2 |
71.7 |
*all patients from the TNBC cohort were included in the No
Hormone Rx cohort
A chart accompanying this announcement is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/b7cc0d48-9396-43f5-bcee-807a6daee99d
Notably, the patient demographics and baseline disease
characteristics were well balanced between the two arms, both in
the intention-to-treat (ITT) and TNBC populations.
Elizabeth A. Mittendorf, M.D., Ph.D., 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
commented: “It is encouraging to see that the final analysis of the
NPS +/- trastuzumab Phase 2b trial for the TNBC cohort not only
confirms the previously reported positive data, presented in full
today, but also provides evidence for a significant clinically
positive outcome with the combination. In many early stage TNBC
patients, the benefit of initial treatment with neoadjuvant
chemotherapy is incomplete, leaving room for improvement,
especially in the adjuvant or maintenance setting. To date,
targeted therapies have not proven effective for TNBC. Putting HER2
in the crosshairs of an immunotherapeutic combination, in this case
NPS plus trastuzumab in triple-negative (HER2 IHC 1+/2+; hormone
receptor negative) breast cancer patients, makes sense biologically
considering preexisting activated cellular immunity in most
patients with these tumors and the pharmacodynamic synergy between
these two agents.”
Dr. Stergiou further stated, “We look forward to continuing our
discussions with U.S. and European regulatory agencies on the most
optimal and expeditious development path for NPS in TNBC. To that
end, we will be meeting with the FDA in December. We are also
engaging in ongoing discussions with potential partners. I would
like to thank all patients who participated in this NPS study, and
their families and outstanding physicians, as well as our team at
SELLAS and our supportive stockholders. As October is breast
cancer awareness month, one could not have thought of a better
timing to present this data, consistent with our mission to develop
potentially life-saving drugs for patients in need.”
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.
Conference Call
SELLAS will host a conference call on Monday, October 22, 2018
at 8:00 a.m. ET to discuss these data. To participate in the
conference call, please dial (866) 416-7995 (domestic) or +1 (409)
217-8225 (international) and refer to conference ID 5571389.
A live webcast of the call can be accessed under "Events &
Presentations" in the Investors section of the Company's website at
www.sellaslifesciences.com.
An archived webcast recording will be available on the SELLAS
website beginning approximately two hours after the call.
About ESMO
The European Society for Medical Oncology (ESMO) is Europe’s
leading non-profit medical oncology organization. ESMO is a
membership-based society, comprising of 500 expert committee
members and 18,000 oncology professionals. ESMO organizes a large
number of meetings to provide its members and the community with
the resources they need and also plays a major role in public
policy and European affairs. The ESMO 2018 Annual Meeting
represents a multi-professional platform for oncology education and
exchange, and for immense international visibility for scientific
research, and will be held under the tagline “Securing access to
optimal cancer care.”
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 Phase 3 clinical
trials planned (pending funding availability) for GPS in two
indications, acute myeloid leukemia (AML) and malignant pleural
mesothelioma (MPM) and is also developing GPS as a potential
treatment for multiple myeloma (MM) and ovarian cancer.
SELLAS plans to study GPS in up to four additional
indications. SELLAS has received Orphan Drug designations for
GPS from the U.S. Food & Drug Administration (FDA) for AML,
MPM, and MM, as well as from the European Medicines Agency, for AML
and MPM; GPS also received Fast Track designation for AML and MPM
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+, following
standard of care.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
Forward-Looking StatementsThis 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 development of nelipepimut-S (NeuVaxTM, NPS) for breast
cancer, meetings with regulatory authorities and the outcome of
partnering discussions. 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.
Investor Contacts:Will O’ConnorStern Investor
Relations, Inc.212-362-1200ir@sellaslife.com
David Moser, JDSellas Life Sciences
Group813-864-2571info@sellaslife.com
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