G1 Therapeutics to Continue Pivotal Phase 3 Trial of Trilaciclib in Metastatic Triple Negative Breast Cancer Following Interim Analysis by Independent Data Monitoring Committee
12 Febrero 2024 - 3:05PM
G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today announced that the independent Data Monitoring
Committee (DMC) recommended continuation of the pivotal Phase 3
trial (PRESERVE 2), evaluating trilaciclib in combination with
gemcitabine and carboplatin for the first line treatment of
metastatic triple negative breast cancer (mTNBC), to the final
analysis. This final analysis evaluating Overall Survival (OS) is
estimated to occur in the third quarter of 2024 and will be
conducted on the intent-to-treat (ITT) population. The DMC did not
express any concerns regarding safety or recommend any other
changes to the study. G1 remains blinded to all data as the early
stopping criteria were not met during the interim analysis.
“We remain confident in the ability of trilaciclib to ultimately
achieve the OS primary endpoint based on the robust survival
benefit demonstrated in the prior randomized Phase 2 study, which
continued to meaningfully increase over time as patients received
subsequent therapies, as well as the increased statistical power
for the final analysis of this pivotal study,” said Jack Bailey,
Chief Executive Officer at G1 Therapeutics. “While a positive
interim analysis would have enabled us to bring this therapy to
patients in need sooner, we look forward to completing the study
and potentially making this meaningful new treatment option
available to patients with this highly aggressive form of breast
cancer as early as next year.”
Trilaciclib, an IV-administered transient CDK4/6 inhibitor, is a
first-in-class therapy designed to preserve bone marrow and immune
system function during cytotoxic therapy to improve patient
outcomes. PRESERVE 2 is a global, multi-center, randomized
placebo-controlled, line extension pivotal Phase 3 trial of
trilaciclib in patients with locally advanced unresectable or
metastatic TNBC. Patients meeting eligibility requirements were
randomized 1:1 to receive either trilaciclib or placebo
administered prior to first-line gemcitabine and carboplatin (GCb).
The regimen is given intravenously (IV) on Days 1 and 8 in 21-day
cycles. Treatment is administered until disease
progression.About Triple Negative Breast Cancer
(TNBC)Breast cancer is the most commonly diagnosed cancer
worldwide, with over 2.3 million new cases each year. 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 oncology biopharmaceutical company whose mission
is to develop and deliver next-generation therapies that improve
the lives of those affected by cancer, including the Company’s
first commercial product, COSELA® (trilaciclib). The Company is
also evaluating therapies in combination with cytotoxic therapies
and/or immunotherapy in areas of high unmet need including
triple-negative breast cancer and extensive stage small cell lung
cancer. G1’s goal is to provide innovative therapeutic advances for
people living with cancer. G1 is based in Research Triangle Park,
N.C. For additional information, please visit
http://www.g1therapeutics.com and follow us on X (formerly known as
Twitter) @G1Therapeutics and LinkedIn.
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,"
“could”, “believe,” “goal”, “projections,” "estimate," "intend,"
“indicate,” “potential,” “opportunity,” “suggest,” 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, that the
survival benefit observed in the Phase 2 trial appears to
meaningfully increase over time as patients received subsequent
therapies, and that completion of the trial will enable G1 to make
this potentially meaningful new treatment available to patients
living with mTNBC as early as next year, 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 (trilaciclib); 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 commercial-stage
company; chemotherapy shortages and market conditions. Our business
is subject to substantial risks and uncertainties, including those
referenced above. Investors, potential investors, and others should
give careful consideration to these risks and uncertainties. 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.
G1 Therapeutics Contact:
Will RobertsVice President, Communications Officer919-907-1944
wroberts@g1therapeutics.com
G1 Therapeutics (NASDAQ:GTHX)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
G1 Therapeutics (NASDAQ:GTHX)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024