G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today announced the initiation of PRESERVE 2, a pivotal
Phase 3, randomized, double-blind, placebo-controlled study of
COSELA™ (trilaciclib) in patients receiving first- or second-line
gemcitabine and carboplatin chemotherapy for locally advanced
unresectable or metastatic triple-negative breast cancer (mTNBC).
COSELA shows preclinical and clinical evidence of immune system
enhancement which G1 is exploring in clinical trials in a variety
of different tumor types to evaluate the potential of increased
anti-tumor efficacy. Results of this study are expected in the
second half of 2023.
“As a physician who treats people living with breast cancer, I
can attest to the great need for new therapies to extend life while
not adding to the side effect burden of chemotherapy,” said Joyce
O'Shaughnessy, MD, Chair of Breast Cancer Research at Baylor
University Medical Center, Texas Oncology, US Oncology in Dallas,
TX. “Gemcitabine/carboplatin has historically been one of the
standard first-line regimens for patients undergoing chemotherapy
for mTNBC. In a Phase 2 study, when trilaciclib was administered
prior to this regimen, it enhanced antitumor efficacy compared to
gemcitabine/carboplatin alone, and improved overall survival with
statistical significance. This is an important finding for patients
with mTNBC, and for physicians who treat them. I’m excited to begin
enrolling patients in this registrational trial and look forward to
the possibility of a new, well-tolerated, and life-extending agent
for my patients.”
Patient enrollment in PRESERVE 2 is now underway. The study will
enroll two cohorts of patients. Cohort 1 (n=170) will evaluate
patients receiving first-line therapy, regardless of PD-L1 status,
who are PD-1/PD-L1 inhibitor-naïve. Cohort 2 (n=80) will evaluate
PD-L1 positive patients receiving second-line therapy following
prior PD-1/PD-L1 inhibitor therapy in the locally advanced
unresectable/metastatic setting. These two cohorts are adequately
powered and considered independent of each other. Therefore, the
efficacy and safety data collected for each cohort will be analyzed
separately.
Within each cohort, patients meeting entry criteria will be
randomly assigned (1:1) to receive either COSELA prior to
gemcitabine and carboplatin (GC) therapy (the same dosing regimen
used in Group 2 of our Phase 2 study) or placebo prior to GC
therapy. Study drugs will be administered intravenously (IV) on
Days 1 and 8 in 21-day cycles. Study drug administration will
continue until progressive disease per Response Evaluation Criteria
in Solid Tumors (RECIST) v1.1 or clinical progression as determined
by the Investigator, unacceptable toxicity, withdrawal of consent,
Investigator decision, or the end of the study, whichever occurs
first.
The primary endpoint in Cohort 1 is to evaluate the effect of
COSELA on overall survival (OS) compared with placebo in patients
receiving first-line GC. The primary endpoint of Cohort 2 is to
evaluate the effect of COSELA on OS compared with placebo in
patients receiving GC as second line therapy after treatment with a
PD-1/PD-L1 inhibitor. Key secondary endpoints in both trials
include assessment of the effect of COSELA on patients’ quality of
life compared with placebo.
“Given that triple-negative breast cancer tends to be more
aggressive and have a worse prognosis than other types of breast
cancer, we recognize and share the urgency to conduct this trial
and are enthusiastic about the potential for COSELA to
significantly improve TNBC patient outcomes,” said Raj Malik, M.D.,
Chief Medical Officer at G1 Therapeutics. “This registrational
trial follows the final data from our Phase 2 trial in mTNBC which
were presented in December at the 2020 San Antonio Breast Cancer
Symposium (SABCS) meeting, showing a strong survival benefit in
patients receiving COSELA compared to placebo when given prior to
chemotherapy, and regardless of tumor PD-L1 status. Based on those
data, we believe that the unique mechanism of action of COSELA has
the potential to increase antitumor efficacy and be highly
beneficial to people fighting TNBC.”
Results from Randomized Phase 2 Trial of COSELA
in mTNBC
New data presented at the 2020 SABCS meeting showed that COSELA
significantly improved overall survival (OS) in patients with mTNBC
treated with COSELA prior to administration of a chemotherapy
regimen of gemcitabine/carboplatin (GC) compared with GC alone, and
that COSELA enhanced immune system function. Patients were
randomized to receive GC only (Group 1) or GC plus one of two
dosing schedules of COSELA: COSELA administered on the day of
chemotherapy (Group 2) or COSELA administered the day prior to and
the day of chemotherapy (Group 3). Compared to GC alone (Group 1),
statistically significant improvements in OS were achieved in both
COSELA arms (Group 2: HR=0.31, p=0.0016; Group 3: HR=0.40,
p=0.0004). As of the data cutoff of July 17, 2020, the median OS
was 12.6 months in patients receiving GC alone, not yet reached for
Group 2, and 17.8 months in Group 3. The median OS for Groups 2 and
3 combined was 19.8 months (HR=0.37, p<0.0001). Patients with
both PD-L1-positive and PD-L1-negative tumors treated with COSELA
and GC demonstrated improvement in OS compared to patients
receiving GC alone, with the PD-L1-positive subset achieving
statistically significant improvement. Data from T-cell clonality
analysis suggest that administering COSELA prior to chemotherapy
enhanced immune system function. (Poster here)
About Triple Negative Breast Cancer
(TNBC)According to the American Cancer Society, nearly
300,000 new cases of invasive breast cancer are diagnosed annually
in the U.S. Triple-negative breast cancer makes up approximately
15-20% of such diagnosed breast cancers. TNBC is cancer that tests
negative for estrogen receptors, progesterone receptors, and excess
HER2 protein. Because mTNBC cells lack key growth-signaling
receptors, patients do not respond well to medications that block
estrogen, progesterone, or HER2 receptors. Instead, treating mTNBC
typically involves chemotherapy, radiation, and surgery. TNBC is
considered to be more aggressive and have a poorer prognosis than
other types of breast cancer. In general, survival rates tend to be
lower with mTNBC compared to other forms of breast cancer, and
mTNBC is also more likely than some other types of breast cancer to
return after it has been treated, especially in the first few years
after treatment. It also tends to be higher grade than other types
of breast cancer.
About G1 TherapeuticsG1 Therapeutics, Inc. is a
commercial-stage biopharmaceutical company focused on the
development and commercialization of next generation therapies that
improve the lives of those affected by cancer, including the
Company’s first commercial product, COSELA™ (trilaciclib). G1 has a
deep clinical pipeline and is executing a tumor-agnostic
development plan evaluating COSELA in a variety of solid tumors,
including colorectal, breast, lung, and bladder cancers. G1
Therapeutics is based in Research Triangle Park, N.C. For
additional information, please visit www.g1therapeutics.com and
follow us on Twitter @G1Therapeutics.
G1 Therapeutics™ and the G1 Therapeutics logo and COSELA™ and
the COSELA logo are trademarks of G1 Therapeutics, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as "may," "will," "expect," "plan," "anticipate,"
"estimate," "intend" and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
Forward-looking statements in this press release include, but are
not limited to, COSELA’s (trilaciclib) possibility to improve
patient outcomes, our pivotal Phase 3 trial of COSELA in mTNBC may
not be able to replicate the strong survival benefit we observed in
our Phase 2 trial of COSELA in mTNBC, delays in the enrollment of
patients in our Phase 3 trial of COSELA in mTNBC, may delay or
prevent our plans, and COSELA may fail to achieve the degree of
market acceptance for commercial success, are based on the
company’s expectations and assumptions as of the date of this press
release. Each of these forward-looking statements involves risks
and uncertainties. Factors that may cause the company’s actual
results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in
the company’s filings with the U.S. Securities and Exchange
Commission, including the "Risk Factors" sections contained therein
and include, but are not limited to, the company’s dependence on
the commercial success of COSELA; the development and
commercialization of new drug products is highly competitive; the
company’s ability to complete clinical trials for, obtain approvals
for and commercialize any of its product candidates; the company’s
initial success in ongoing clinical trials may not be indicative of
results obtained when these trials are completed or in later stage
trials; the inherent uncertainties associated with developing new
products or technologies and operating as a development-stage
company; and market conditions. Except as required by law, the
company assumes no obligation to update any forward-looking
statements contained herein to reflect any change in expectations,
even as new information becomes available.
Contact:
Will RobertsG1 Therapeutics, Inc.Vice PresidentInvestor
Relations and Corporate Communications(919) 907-1944
wroberts@g1therapeutics.com
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