‒ Poster for GP2 Phase IIb clinical trial final efficacy
analysis was presented during the 2020 San Antonio Breast Cancer
Symposium (SABCS) today
‒ Phase IIb clinical trial was a prospective, randomized,
single-blinded, placebo-controlled, multi-center (16 sites) trial
led by MD Anderson Cancer Center
‒ Kaplan Meier analysis of disease free survival for patients
treated with GP2 immunotherapy shows 100% survival (0% breast
cancer recurrences, p = 0.0338) following surgery and Herceptin
treatment over median 5 years of follow-up
‒ Company now preparing to enter a Phase III clinical trial to
treat a similar population of moderate to severe (high risk T1,
T2-T4) breast cancer patients
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, today announced the
publication of a poster for the GP2 Phase IIb clinical trial final
efficacy analysis at the San Antonio Breast Cancer Symposium in a
virtual format. The CEO of Greenwich LifeSciences, Snehal Patel,
also recorded an audio track providing an overview. The full poster
with figures, tables, and audio can be accessed or downloaded here
on the Company website, as well as on the conference website by
attendees.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20201209005460/en/
Poster PS10-23: San Antonio Breast Cancer
Symposium 2020 Poster Presentation of GP2 Median 5 Year Top-Line
Data (Graphic: Business Wire)
The poster presents the final 5 year follow-up disease-free
survival curves evaluating the reduction of breast cancer
recurrences for both HER2/neu 3+ (Figure 1) and HER2/neu 1-2+
(Figure 2) patient populations, including the demographics (Table
1) for stage of cancer, hormone receptor status, node status, and
prior treatment with chemotherapy, radiation, endocrine therapy, or
trastuzumab (Herceptin).
Mr. Patel commented, “The poster presented at the SABCS is
important because the Kaplan Meier survival curves and demographic
data further validate our promising HER2 3+ Phase IIb data and
support our plan to commence a Phase III trial in 2021. Recurring
breast cancer affects 1 in 8 women. Approximately 50% of women with
recurring breast cancer do not respond to Herceptin or Kadcyla,
resulting in metastatic breast cancer and a poor prognosis.
Approximately 80-85% of metastatic breast cancer patients do not
survive. By addressing this unmet need, GP2 may reach a potential
market exceeding $5 billion.”
The conclusions of the poster are as follows:
‒ The trial met all of its clinical endpoints for HER2/neu 3+
patients, concluding that the first 6 intradermal injections of
GP2+GM-CSF safely elicited a potent immune response and reduced
recurrence rates to 0% in HER2/neu 3+ patients, who received a
standard course of Herceptin after surgery. This reduction of
recurrence rate was maintained over the gold standard of 5 years of
follow-up. A pivotal Phase III trial is being initiated to treat
HER2/neu 3+ patients in the neoadjuvant setting.
‒ GP2 may also be effective when administered in combination
with Herceptin based therapeutics in HER2/neu 1-2+ patient
populations or other HER2/neu expressing cancers.
Excerpts of the poster are below:
Poster PS10-23: San Antonio Breast Cancer Symposium Poster
Presentation of Median 5 Year Top-Line Data
The median 5 year top-line data described below was presented at
the San Antonio Breast Cancer Symposium in a poster on December 9,
2020, entitled “Five year median follow-up data from a prospective,
randomized, placebo-controlled, single-blinded, multicenter, Phase
IIb study evaluating the reduction of recurrences using HER2/neu
peptide GP2+GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in
HER2 positive women with operable breast cancer.”
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. The trial's primary objective was
to determine if treatment with GP2, a HER2-derived peptide, reduces
recurrence rates.
Each enrolled and consented subject was randomized and scheduled
to receive a total of 6 GP2+GM-CSF (500 mcg GP2:125 mcg GM-CSF) or
placebo (125 mcg GM-CSF alone) intradermal injections every 3-4
weeks as part of the Primary Immunization Series (“PIS”) for the
first 6 months and 4 GP2+GM-CSF booster or placebo intradermal
injections every 6 months thereafter. Boosters were introduced
during the trial, thus some patients did not receive all 4
boosters.
This 168 patient (Intent to Treat, “ITT”: n=180) basket trial
across 16 clinical sites explored 96 HER2 3+ patients, who received
a standard course of trastuzumab after surgery and subsequently
completed the full PIS or placebo, starting the PIS at median 17.1
months after surgery, and 72 HER2 1-2+ patients, who did not
receive trastuzumab after surgery and subsequently completed the
full PIS or placebo, starting the PIS at median 10.8 months after
surgery. Subject disease characteristics are described in Table 1
of the poster.
Since GP2 is synergistic with trastuzumab, and the HER2 1-2+
patients did not receive trastuzumab, it was prespecified to
compare recurrence rates ITT versus per protocol in these 2
distinct, independently reported populations, excluding those
patients who did not complete the PIS.
Figure 1 of the poster depicts evidence that disease free
survival (“DFS”) is more likely in HER2 3+ GP2-treated subjects.
After 5 years of follow-up, the Kaplan-Meier estimated 5-year DFS
rate in the 46 HER2 3+ patients treated with GP2+GM-CSF, if the
patient completed the PIS, was 100% versus 89.4% (95% CI:76.2,
95.5%) in the 50 placebo patients treated with GM-CSF (p = 0.0338).
As shown in Table 1, the treated versus placebo HER2 3+ patients
were well-matched, where approximately 53% were stage T1, 41% were
stages T2-T4, 55% were node positive, 58% were hormone receptor
positive and received endocrine therapy, 77% received adjuvant
radiation, 77% received adjuvant chemotherapy, and 89% received
trastuzumab.
GP2 was shown to be well tolerated with no SAEs and elicited a
potent immune response measured by local skin tests and
immunological assays, which suggest peak immunity is reached at 6
months upon completion of the PIS.
About SABCS
The 43rd annual SABCS has grown to be the industry’s premier
breast cancer conference for basic, translational, and clinical
cancer research professionals. It is well-known for presenting the
latest breast cancer data from all over the world. More than 7,500
health care professionals from more than 90 countries attend
annually. Baylor College of Medicine became a joint sponsor of
SABCS in 2005. The Cancer Therapy & Research Center at UT
Health Science Center San Antonio and American Association for
Cancer Research began collaborations with SABCS in 2007. For more
information, please visit the conference website at:
https://www.sabcs.org/
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: www.greenwichlifesciences.com
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. 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 Securities and Exchange Commission. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201209005460/en/
Company Contact Snehal Patel Investor Relations (832)
819-3232 info@greenwichlifesciences.com
Investor & Public Relations Contact for Greenwich
LifeSciences Inc.: Dave Gentry RedChip Companies Inc. Office:
1-800-RED CHIP (733 2447) Cell: (407) 491-4498 dave@redchip.com
Greenwich LifeSciences (NASDAQ:GLSI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Greenwich LifeSciences (NASDAQ:GLSI)
Historical Stock Chart
From Apr 2023 to Apr 2024