G1 Therapeutics Provides Corporate Update at the 42nd Annual J.P. Morgan Healthcare Conference
08 Enero 2024 - 5:45AM
G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today announced new clinical, commercial and corporate
updates, including encouraging preliminary overall survival (OS)
data from the Company’s ongoing Phase 2 trial of trilaciclib in
combination with the ADC sacituzumab govitecan (SG) in patients
with TNBC. This update is now available in a new corporate
presentation which will be used during the 42nd Annual J.P. Morgan
Healthcare Conference and can be accessed here.
“We have entered 2024 with strong momentum across our business,
including compelling preliminary overall survival data from our ADC
combination study in metastatic TNBC, accelerating COSELA sales
volume in the most recent quarter, and awaiting near-term data from
our 1L TNBC pivotal study for trilaciclib,” said Jack Bailey, Chief
Executive Officer of G1 Therapeutics. “We believe the initial OS
results from our ADC trial may serve as proof-of-concept for the
potential of trilaciclib to improve overall survival in combination
with the growing class of TROP2 ADCs across TNBC indications and
beyond. More imminently, we look forward to the interim OS analysis
of our pivotal 1L TNBC trial, which has the potential to transform
treatment for women living with this aggressive and
difficult-to-treat cancer.”
The update includes the following:
Clinical
- Initial efficacy results
from ongoing Phase 2 ADC trial suggest improved OS among patients
receiving trilaciclib in combination with a TROP2 ADC:
Preliminary data from the ongoing Phase 2 trial of trilaciclib in
combination with the ADC sacituzumab govitecan (SG) in metastatic
TNBC patients suggests clinically meaningful improvements in OS
among patients receiving trilaciclib in combination with SG
compared to SG alone based on historical data from the ASCENT
trial, including (1) current median OS of 17.9 months with
trilaciclib vs 12.1 months for SG alone and (2) estimated 12-month
survival of 59% of patients receiving trilaciclib in combination
with SG, which would be a ~20% improvement over SG alone. The
Company expects to provide updated OS data from this study
mid-2024.
- Interim OS analysis of
ongoing 1L TNBC pivotal trial expected in 1Q24: This Phase
3 trial builds upon the clinically meaningful and statistically
significant OS results demonstrated in the previous Phase 2 TNBC
trial. Achievement of the OS endpoint would enable global
regulatory submissions.
- OS continues to improve
over time for Phase 2 TNBC patients receiving subsequent
anti-cancer therapy (SACT): Among patients receiving SACT
after conclusion of study drug in the previous Phase 2 TNBC trial,
the OS benefit in the trilaciclib arm increased over time as
patients received SACT. Patients in the trilaciclib arms receiving
subsequent 2L+ chemotherapy exhibited a median OS of 14.0 months
from start of SACT, compared to patients in the chemotherapy arm
receiving subsequent 2L+ chemotherapy of 5.8 months (p=0.001). The
median OS of 14.0 months in the trilaciclib arms also compares
favorably to historical 2L+ benchmarks for chemotherapy and SG of
6.7 months and 12.1 months in the ASCENT trial, respectively.
Commercial
- Strong COSELA® (trilaciclib)
volume growth in 4Q23: COSELA vial volume grew 19% in 4Q23
over the prior quarter as platinum-based chemotherapy shortages
began to abate. COSELA vial volume in October, November, and
December 2023 represented the highest volume months since
launch.
- High levels of satisfaction
with COSELA: Up to 91% of prescribing oncologists and
nurse practitioners / physician assistants rate satisfaction with
COSELA as “very high” primarily driven by fewer hospitalization and
protection of multiple cell lineages, which is also supported by
real-world evidence.
Corporate
- Global opportunities in TNBC
expected to be pursued through partnerships: If positive,
the Phase 3 1L TNBC OS results would be expected to support
regulatory submissions and enable reimbursement in territories
outside of the U.S. to drive global expansion through future
partnerships.
- Cash runway to extend into
2025: The Company expects approximately $82M in cash, cash
equivalents, and marketable securities as of December 31, 2023, and
a >30% decrease in 2023 operating expenses compared to that of
2022.
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, those relating
to expectations for the commercial success of COSELA®
(trilaciclib), our ability to further develop and expand the use of
COSELA in the treatment of extensive-stage small cell lung cancer,
that the initial OS results from the ADC trial serve as
proof-of-concept for the potential of trilaciclib to improve
overall survival in combination with the growing class of TROP2
ADCs, that achievement of OS endpoint in ongoing PRESERVE 2 Phase 3
clinical trial would provide the potential to transform treatment
for women living with this aggressive and difficult-to-treat cancer
and is expected to enable global regulatory submissions, and that
G1’s cash runway is expected to extend into 2025, 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 Contacts:Will
RobertsCommunications OfficerVice President, Investor Relations and
Corporate Communications(919) 907-1944
wroberts@g1therapeutics.com
G1 Therapeutics (NASDAQ:GTHX)
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