- Poster published at the 2021 American Society of Clinical
Oncology (ASCO) Annual Meeting shows the final 5 year safety data
from the Phase IIb breast cancer clinical trial.
- Final safety conclusions are that GP2 immunotherapy is well
tolerated and that no serious adverse events related to GP2
immunotherapy were reported over the full 5 year follow-up
period.
- Final 5 Year Data Set of GP2 Phase IIb
Trial is Now Complete: Figure 1 of the poster shows a time
series of the GP2 immunotherapy injections, adverse events (AE),
immune response, and 100% disease-free survival (0% recurrence
rate) in HER2 positive breast cancer patients over median 5 years.
This time series highlights that the 10 GP2 immunotherapy
injections over the first 2.5 years (as depicted by the 10 arrows)
created a potent immune response that peaked at 6 months. The
immune response includes injection site and systemic reactions
(types of adverse events) that also peaked at 6 months. These
adverse events are a positive sign that the immune system responded
to GP2 immunotherapy and prevented metastatic breast cancer
recurrence. Adverse events were temporally associated with GP2
injections and declined after GP2 injections ended.
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a
clinical-stage biopharmaceutical company focused on the development
of GP2, an immunotherapy to prevent breast cancer recurrences in
patients who have previously undergone surgery, presented an
abstract and poster of the final 5 year GP2 Phase IIb clinical
trial safety data at the 2021 ASCO Annual Meeting.
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the full release here:
https://www.businesswire.com/news/home/20210607005374/en/
Figure 1 of Poster Presentation 542 from
2021 ASCO Annual Meeting Showing GP2 Immunotherapy 5 Year Time
Series of Dosing, Safety, Immune Response, and Disease Free
Survival from Phase IIb Clinical Trial (Graphic: Business Wire)
The abstract can be viewed at the bottom of this press release,
and the full poster, Figures 1-2, Tables 1-2, and an audio track of
the poster by VP of Clinical & Regulatory Affairs Jaye Thompson
can be accessed and downloaded at:
https://greenwichlifesciences.com/clinical-trials/.
It has been previously reported that the completion of the GP2
immunotherapy (GP2+GM-CSF) Primary Immunization Series (PIS)
reduced recurrence rates to 0% over a 5 year follow-up period in
HER2 3+ patients who had received a standard course of trastuzumab
after surgery. The abstract and poster present the final safety
data over the 5 year follow-up period, assessing the safety of GP2
immunotherapy and its relationship to previously presented peak
immunity and recurrence rate data.
Summary of the Final 5 Year Safety
Data:
- GP2 immunotherapy is well-tolerated and no safety signal for
GP2 was identified. Additionally, no serious adverse events related
to GP2 immunotherapy were reported over the full 5 year treatment
and follow-up periods.
- The majority of patients experienced mild or moderate injection
site reactions, which accounted for approximately 70% of reported
adverse events.
- The incidence of adverse events was similar across HER2 3+ and
HER2 1-2+ breast cancer patients, consistent with the previously
reported findings that the immune response was similar across both
patient populations, suggesting that GP2 immunotherapy could be a
potential treatment in HER2 1-2+ patients or in other HER2
expressing cancers.
Snehal Patel, CEO of Greenwich LifeSciences, commented, “The
final 5 year analysis of the safety data in the Phase IIb trial is
now complete and represents an important milestone for the Company.
With the recurrence rate or disease free survival (SABCS 2020),
immune response (AACR 2021), and now safety data (ASCO 2021), the
final design of the planned Phase III trial can be completed. This
final combined data set encourages us to utilize the same treatment
strategy in the planned Phase III trial to conservatively reproduce
these promising results that showed that GP2 immunotherapy may
prevent metastatic breast cancer recurrence. In addition, this
final data set can now be presented to investors and strategic
parties interested in partnering with the Company to co-develop and
license GP2.”
Excerpts from the ASCO Poster
542:
Title: Final five year median follow-up safety data from a
prospective, randomized, placebo-controlled, single-blinded,
multicenter, phase IIb study evaluating the use of HER2/neu peptide
GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2
positive women with operable breast cancer
Safety data was analyzed to assess injection site reactions and
systemic adverse events (AEs) of each treatment arm. Most patients
completed the planned PIS: 81 (91.0%) GP2+GM-CSF and 86 (94.5%)
GM-CSF only. In addition, 77 GP2+GM-CSF and 80 GM-CSF only patients
received all 4 booster injections. The most common injection site
reactions were erythema, induration and pruritis, and they occurred
with similar frequency in the two treatment arms. Injection site
reactions were reported by almost all patients over the course of
vaccinations. Occurring in a smaller percentage of patients, the
most common systemic adverse events were fatigue, headache, and
myalgia/arthralgia, again with similar incidence by treatment arm.
The majority of all events reported were of grade 1, mild severity.
Five GP2+GM-CSF patients reported 6 events considered definitely,
possibly or probably related to study medication, which were grade
3 or 4: induration (2), urticaria, rash, pruritis, and arthralgia.
Urticaria, allergic reaction and hypersensitivity reaction were
considered possibly related events of grade 3 or 4 in GM-CSF only
patients. No serious adverse events considered related to study
medication were reported over the full 5 year treatment and
follow-up periods.
Figure 2 of the poster shows
the maximal severity grade for any adverse event, systemic and
injection site reaction, for each patient. There was no difference
between the two treatment arms. The majority of events were of
grade 1, mild severity. Two patients reported grade 4 adverse
events deemed unrelated to GP2 immunotherapy. One GP2+GM-CSF
patient experienced grade 4 hypoglycemia and recovered. A GM-CSF
only patient was diagnosed with renal cell carcinoma, a second
primary diagnosis, which was classified as grade 4.
Tables 1 & 2 of the
poster show the incidence of adverse events by HER2 status. The
first occurrence of frequently reported adverse events are
tabulated in Table 1. The most common adverse event was injection
site reaction. Almost every patient, in both the GP2+GM-CSF and
GM-CSF only arms, reported injection site reactions. The most
frequent injection site reactions were erythema, pruritus and
induration, as presented in Table 2. The incidence of adverse
events were similar across HER2 3+ and HER2 1-2+ patients, which is
consistent with the previously reported findings that immune
response was similar across HER2 3+ and HER2 1-2+ patients.
ASCO Abstract 542:
Title: Final five-year median
follow-up safety data from a prospective, randomized,
placebo-controlled, single-blinded, multicenter, phase IIb study
evaluating the use of HER2/neu peptide GP2 + GM-CSF vs. GM-CSF
alone after adjuvant trastuzumab in HER2 positive women with
operable breast cancer.
Snehal Patel, David McWilliams, Christine T Fischette, Jaye
Thompson, Mira Patel, and F Joseph Daugherty.
Greenwich LifeSciences, Stafford, TX
Background: The final
analysis of the GP2 prospective, randomized, placebo-controlled,
single-blinded, multicenter Phase IIb trial investigating
GP2+GM-CSF administered in the adjuvant setting to node-positive
and high-risk node-negative breast cancer patients with tumors
expressing any degree of HER2 (immuno-histochemistry [IHC] 1-3+)
(NCT00524277) is now complete with 5 year follow-up. The trial
enrolled HLA-A02 patients randomized to receive GP2+GM-CSF versus
GM-CSF alone. It was previously reported that completion of the
GP2+GM-CSF Primary Immunization Series (PIS) reduced recurrence
rates to 0% over a 5 year follow-up period in HER2 3+ patients, who
received a standard course of trastuzumab after surgery.
Methods: Each enrolled and
consented patient was randomly scheduled to receive a total of 6
GP2+GM-CSF (500 mcg GP2: 125 mcg GM-CSF) or GM-CSF only intradermal
injections every 3-4 weeks as part of the PIS for the first 6
months and 4 GP2+GM-CSF or GM-CSF only booster intradermal
injections every 6 months thereafter. Boosters were introduced
during the trial, thus some patients did not receive all 4
boosters. Injection sight reactions were measured.
Results: Safety data was
analyzed to assess local and systemic toxicity of each treatment
arm. Most subjects completed the planned PIS, 81 (91.0%) GP2+GM-CSF
and 86 (94.5%) GM-CSF only. In addition, 77 GP2+GM-CSF and 80
GM-CSF only subjects received all 4 booster injections. The most
common local toxicities were erythema, induration and pruritis and
they occurred with similar frequency in the two treatment arms.
Local reactions were reported by almost all subjects over the
course of vaccinations. Occurring in a smaller percentage of
subjects, the most common systemic toxicities were fatigue,
headache, and myalgia/arthralgia, again with similar incidence by
treatment group. The majority of all events reported were of Grade
1 mild severity (GP2+GM-CSF 92.5%, GM-CSF only 90.6%). Only 5
events in 4 subjects were considered Grade 3: induration and
maculopapular rash/pruritis, in two GP2+GM-CSF subjects and chest
pain and hypersensitivity reaction in two GM-CSF only subjects. The
incidence of local reactions minimally increased with subsequent
vaccinations; however, the types of events remain unchanged. No
serious adverse events were reported over the full 5 year treatment
and follow-up periods.
Conclusions: The study
confirms the finding from the Phase I trial evaluating GP2+GM-CSF
that the vaccine is safe and well-tolerated. The majority of
patients experienced only mild local and systemic toxicities.
Importantly, toxicities in the GP2+GM-CSF group were comparable to
those seen in the GM-CSF only group, suggesting the toxicities are
attributable to GM-CSF.
About the 2021 ASCO Annual Meeting
Founded in 1964, ASCO is the world's leading professional
organization for physicians and oncology professionals caring for
people with cancer. ASCO offers premier scientific events for
oncology professionals, patient advocates, industry
representatives, and major media outlets worldwide. The ASCO Annual
Meeting program features poster presentations, poster discussion
sessions, clinical science symposia, and dynamic education sessions
about recent advancements in cancer research, treatment, and
patient care. For more information, please visit the conference
website at: https://conferences.asco.org/am/attend.
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over
her lifetime, with approximately 266,000 new breast cancer patients
and 3.1 million breast cancer survivors in 2018. HER2/neu (human
epidermal growth factor receptor 2) protein is a cell surface
receptor protein that is expressed in a variety of common cancers,
including in 75% of breast cancers at low (1+), intermediate (2+),
and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical
company focused on the development of GP2, an immunotherapy to
prevent breast cancer recurrences in patients who have previously
undergone surgery. GP2 is a 9 amino acid transmembrane peptide of
the HER2/neu protein. In a randomized, single-blinded,
placebo-controlled, multi-center (16 sites led by MD Anderson
Cancer Center) Phase IIb clinical trial, no recurrences were
observed in the HER2/neu 3+ adjuvant setting after median 5 years
of follow-up, if the patient received the 6 primary intradermal
injections over the first 6 months (p = 0.0338). Of the 138
patients that have been treated with GP2 to date over 4 clinical
trials, GP2 treatment was well tolerated and no serious adverse
events were observed related to GP2 immunotherapy. Greenwich
LifeSciences is planning to commence a Phase III clinical trial
using a similar treatment regime as the Phase IIb clinical trial.
For more information on Greenwich LifeSciences, please visit the
Company’s website at www.greenwichlifesciences.com and follow the
Company's Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking
statements” that are subject to substantial risks and
uncertainties. All statements, other than statements of historical
fact, contained in this press release are forward-looking
statements. Forward-looking statements contained in this press
release may be identified by the use of words such as “anticipate,”
“believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,”
“seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,”
“target,” “aim,” “should,” "will,” “would,” or the negative of
these words or other similar expressions, although not all
forward-looking statements contain these words. Forward-looking
statements are based on Greenwich LifeSciences Inc.’s current
expectations and are subject to inherent uncertainties, risks and
assumptions that are difficult to predict, including statements
regarding the intended use of net proceeds from the public
offering; consequently, actual results may differ materially from
those expressed or implied by such forward-looking statements.
Further, certain forward-looking statements are based on
assumptions as to future events that may not prove to be accurate.
These and other risks and uncertainties are described more fully in
the section titled “Risk Factors” in the final prospectus related
to the public offering filed with the SEC. Forward-looking
statements contained in this announcement are made as of this date,
and Greenwich LifeSciences, Inc. undertakes no duty to update such
information except as required under applicable law.
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Company Contact Snehal Patel Investor Relations (832)
819-3232 info@greenwichlifesciences.com
Investor & Public Relations Contact for Greenwich
LifeSciences Dave Gentry RedChip Companies Inc. Office:
1-800-RED CHIP (733 2447) Cell: (407) 491-4498 dave@redchip.com
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