Clinically meaningful activity in favor of
investigational nelipepimut-S (NeuVax) + Herceptin arm
SELLAS Life Sciences Group Inc., (Nasdaq:SLS) (SELLAS), a
clinical-stage biopharmaceutical company focused on novel cancer
immunotherapies for a broad range of cancer indications, today
announced positive interim data from the prospective, randomized,
single-blinded, controlled Phase 2b independent
investigator-sponsored clinical trial (IST) of trastuzumab
(Herceptin®) +/- nelipepimut-S (NeuVax™) in HER2 1+/2+ breast
cancer patients in the adjuvant setting to prevent recurrences.
A pre-specified interim analysis, conducted by an independent
Data Safety Monitoring Board (DSMB) of the efficacy and safety data
for the study in an overall population of 275 patients as well as
the two primary study target patient populations (node-positive and
TNBC) after a median follow-up of 19 months, demonstrated a
clinically meaningful difference in median disease-free survival
(DFS) in favor of the active arm (NeuVax + Herceptin), a primary
endpoint of the study, with hazard ratios of 0.67 and 0.61 in the
intent to treat (ITT) and modified ITT (mITT) populations (i.e.,
those who received at least one dose of vaccine or control) as well
as a 34.9% and 39.5% reduction in relative risk of recurrence in
the active versus control arms in the ITT and mITT populations,
respectively.
A clinically meaningful and also statistically significant
difference was found between the two arms in the cohort of patients
(n= 98) with triple-negative breast cancer (TNBC), with a hazard
ratio of 0.26 and a p-value of 0.023 in favor of the NeuVax +
Herceptin combination with a 70.4% reduction in relative risk of
recurrence in the active arm versus control. Similarly, a
clinically meaningful and statistically significant difference was
found between the two arms in favor of the combination in the
cohort of patients not receiving hormonal therapy (n = 110), with a
hazard ratio of 0.24 and a p-value of 0.009 with a 74.1% reduction
in relative risk of recurrence in the active arm versus control.
This pre-specified interim analysis also showed an adverse event
profile with no notable differences between treatment arms.
The addition of NeuVax to Herceptin did not result in any
additional cardiotoxicity compared to Herceptin alone.
“We are indeed excited about these compelling results and
believe NeuVax + Herceptin has the potential to become an important
therapeutic option for TNBC patients. The positive NeuVax
phase 2b data underscores the innovative science and
approach we have taken to investigate this agent’s
potential to address this persistent therapeutic challenge.
We plan to immediately engage with the FDA and EMA, as per the
recommendation of the DSMB, to identify the optimal path forward in
this particular patient group, while advancing the drug through a
partnership or other strategic collaboration,” said Angelos
Stergiou, MD, ScD h.c., President and Chief Executive Officer
of SELLAS. “These are indeed unique and exciting clinical data
for TNBC patients, and I would like to extend my sincere gratitude
to all patients who have participated in this clinical trial, as
well as the study teams.”
The NeuVax + Herceptin combination was found to be generally
well-tolerated. The majority of treatment-emergent adverse events
(TEAE) were of mild or moderate (G1/G2) severity and the majority
of G3 systemic TEAEs were unrelated to NeuVax.
Treatment-related adverse events consisted primarily of
manageable local injection site reactions, skin induration,
pruritus and fatigue.
Additionally, in the NeuVax + Herceptin arm, in vivo
HER2-specific T-cell immune responses (IRs), assessed by delayed
type hypersensitivity (DTH) skin testing, showed a time-dependent
increase in IR potency compared to the earliest tested datapoint
(p=0.000023), while no such increase was observed in the control
arm.
Based on the results above, the DSMB has recommended to
expeditiously seek regulatory guidance by the FDA for further
development of the combination of NeuVax + Herceptin in TNBC,
considering the statistically significant benefit of the
combination therapy seen in this population with large unmet
medical need.
“We are very pleased with these findings, which suggest that
NeuVax + Herceptin may provide a clinically meaningful benefit to
breast cancer patients with low-to-intermediate HER2-expression,
especially given the recent report of the NSABP B-47 trial showing
no benefit in these patients with Herceptin alone.
Furthermore, our trial has shown a significantly improved
disease-free survival in women with TNBC. The favorable
findings for this cohort are particularly promising, given the
limited treatment options for these patients with high risk of
recurrence and death,” commented COL (ret) George E. Peoples, MD,
FACS, the study director and sponsor-investigator of the IST. “We
look forward to presenting these data at an upcoming major medical
conference and to supporting SELLAS in the regulatory and
developmental pathway for NeuVax.”
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 the NeuVax + Herceptin study
This Phase 2b trial is a multi-center, randomized,
single-blinded, placebo-controlled trial in 275 HER2 1+/2+ breast
cancer patients with positive nodes and/or TNBC. The study combines
NeuVax and trastuzumab (Herceptin) in the adjuvant setting aiming
to prevent recurrence or death. Tumors in these women show low
levels of expression of HER2, as measured by immunohistochemistry
(IHC), i.e., at a level of either 1+ or 2+ and, hence, these
patients are not considered candidates for Herceptin. Patients who
are hormone receptor-negative and HER2 1+/2+ by IHC are currently
defined as ‘triple-negative’ breast cancer (TNBC) patients. NeuVax
(nelipepimut-S) is a potentially first-in-class, HER2-directed
cancer immunotherapy and is the immunodominant peptide derived from
the extracellular domain of the HER2 protein, a well-established
target for therapeutic intervention in breast carcinoma. The
nelipepimut-S sequence stimulates specific CD8+ cytotoxic T
lymphocytes (CTLs) following binding to specific HLA molecules on
antigen presenting cells (APC) and destroy HER2 expressing cancer
cells.
About SELLAS Life Sciences GroupSELLAS 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 and ovarian cancer. SELLAS plans to study GPS in up
to four additional indications. SELLAS has received Orphan
Drug designations from the U.S. Food & Drug Administration
(FDA), as well as the European Medicines Agency, for GPS in AML and
MPM; GPS also received Fast Track designation for AML and MPM from
the FDA.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to the results of
clinical studies and as to further development of nelipepimut-S
(NeuVax) for breast cancer. 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, uncertainties related to timing and ability to obtain
needed shareholder consent in a timely manner, the uncertainty of
regulatory approval, the uncertainty of partnering its clinical
assets, and other risks and uncertainties affecting SELLAS and its
development programs. 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:Will O’ConnorStern Investor
Relations, Inc.212-362-1200ir@sellaslife.com
David Moser, JDSELLAS Life Sciences Group,
Inc.813-864-2571info@sellaslife.com
Source: SELLAS Life Sciences Group, Inc.
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