Clinically Meaningful and Statistically
Significant Decrease in the Frequency of Clinically Detected
Recurrences in the TNBC Cohort Treated with Nelipepimut-S plus
Trastuzumab (p=0.004)
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 additional data on patterns
of clinical relapses (including organ or site of recurrence), as
well as results from a preplanned secondary efficacy analysis
across various predefined subgroups from 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 at the 41st San
Antonio Breast Cancer Symposium (SABCS) in San Antonio, TX.
These new data show a decrease in the total number of clinically
detectable relapses with the combination of NPS + trastuzumab
(7.5%) vs. trastuzumab alone (27.3%), p-value 0.004, which
represents a 72.5% relative reduction in risk of relapse across
time with a median follow up of 26.1 months in favor of the
combination arm. Results from a planned analysis (log-rank)
of the difference in disease free survival (DFS) outcomes between
the two arms of the study in prespecified TNBC patient subgroups
(patients who received neoadjuvant chemotherapy, expressed lower
HER2, were 51 years or older, or had AJCC 7th Edition stage I/II
TNBC), showed a clinically meaningful and statistically
significant effect (p-value range: 0.004 – 0.014) in these
subgroups in favor of the NPS plus trastuzumab combination arm.
There was an average decrease of 84.2% in the relative risk of
relapse or death at 24 months across these four subgroups of TNBC
patients treated with NPS plus trastuzumab vs trastuzumab alone.
The full data are summarized in the table below:
|
Comparison between NPS + trastuzumab vs. trastuzumab
arms |
Patient subgroups
within the TNBC cohort |
Hazard Ratio
(HR) |
HR 95% Confidence
Interval |
P-value
(difference in favor of NPS + trastuzumab) |
Decrease in
relative risk of relapse or death at 24 mos. (in favor of NPS +
trastuzumab) |
Received Neoadjuvant Chemotherapy |
0.226 |
0.063 - 0.815 |
0.013 |
78.1% |
Harbored BC with HER2 IHC 1+ expression level |
0.178 |
0.038 - 0.837 |
0.014 |
81.3% |
Aged ≥ 51 years |
0.144 |
0.031 - 0.656 |
0.004 |
77.4% |
AJCC 7 Stage I/II at diagnosis |
Incalculable* |
N/A |
0.006 |
100% |
*no DFS events occurred in AJCC 7 stage I/II TNBC patients
treated with NPS plus trastuzumab.
“These new data provide insights on the pattern of clinically
detectable relapses across various sites/organs, as well as add to
our knowledge of the specific potential benefit distribution within
the TNBC cohort. The results in four predefined TNBC subgroups
inform us of the types of TNBC patients with residual disease after
neoadjuvant chemotherapy who may potentially benefit when treated
with NPS plus trastuzumab in the adjuvant setting. As previously
announced, we are on track to meet with the U.S. Food and Drug
Administration this month on the most expeditious and appropriate
development path for NPS in TNBC,” said Nicholas J. Sarlis, MD,
PhD, Executive Vice President and Chief Medical Officer of
SELLAS.
“We are very pleased with the results of these new analyses
which indicate that the NPS plus trastuzumab combination - when
given in the adjuvant setting after frontline therapy - could
potentially improve outcomes across specific predefined subgroups
of patients with early-stage TNBC, an aggressive subtype of breast
cancer. The clinically meaningful and statistically significant
decrease in the frequency of clinically detectable relapses - with
a median follow-up of over 26 months - indicates a high degree of
internal consistency,” 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. “The data presented today are
consistent with the previously reported beneficial effect seen in
the TNBC cohort at large and are consistent with the
immunobiological mechanism of action of nelipepimut-S.”
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.
SABCS Presentation Information
Date and Time: Thursday, December 6, 2018; 8:00 – 10:00 am ET
Poster Session 2: Treatment: Immunotherapy (clinical)Poster Hall
Location: Hall 1Abstract ID: P2-09-01Title: Subgroups analysis of a
multicenter, prospective, randomized, blinded phase 2b trial of
trastuzumab + nelipeptimut-S (NeuVax) vs. trastuzumab for
prevention of recurrence in breast cancer patients
About SABCS
The mission of the SABC Symposium (SABCS) is to provide
state-of-the-art information on breast cancer research. Since 2007,
the SABCS has been jointly sponsored by the Cancer Therapy &
Research Center (CTRC) at the University of Texas Health Science
Center - San Antonio, the Baylor College of Medicine and the
American Association for Cancer Research (AACR).
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) and the
European Medicines Agency (EMA) for AML, MPM, and 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 TNBC patients,
following standard of care.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
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 development of
nelipepimut-S (NeuVax™, NPS) for breast cancer and meetings with
regulatory authorities. 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 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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