G1 Therapeutics Provides Update on Phase 3 PRESERVE 2 Trial in Patients Receiving Trilaciclib Prior to First Line Chemotherapy in Metastatic Triple Negative Breast Cancer (mTNBC)
June 24 2024 - 6:30AM
G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today announced topline results from the final OS analysis
of its Phase 3 PRESERVE 2 trial evaluating the efficacy and safety
of trilaciclib administered prior to chemotherapy (gemcitabine and
carboplatin; GCb) in patients with metastatic TNBC.
The study did not demonstrate a statistically significant
treatment effect in the ITT population (n=187) with a hazard ratio
(HR) of 0.91 (p=0.884). The median OS in the trilaciclib plus GCb
arm was 17.4 months compared to 17.8 months in the control arm.
Median OS numerically favored the trilaciclib arm in both PD-L1
subgroups (positive and negative), though neither achieved
statistical significance. Varying effects were observed across
regions and patients who received different types of subsequent
therapies; these findings will be evaluated further. The safety
profile of trilaciclib with GCb observed in the trial was
consistent with prior studies, and no new safety signals were
identified. Consistent with other trilaciclib studies, evidence of
myeloprotection was observed, including a reduction in the
occurrence of severe neutropenia, which occurred in 8% of patients
who received trilaciclib compared to 29% of patients in the control
arm. The Company will submit the results of this trial to a future
medical conference.
“The unexpected results from PRESERVE 2 underscore the challenge
of developing new therapies for triple negative breast cancer,”
said Jack Bailey, Chief Executive Officer of G1 Therapeutics. “We
are disappointed that this trial did not deliver the benefit that
we anticipated to people living with TNBC. We are also grateful to
the patients who participated in this trial, their families, and
their healthcare teams including the clinicians and their
staff.”
Mr. Bailey continued, “We will now further our focus on both
accelerating and expanding the growth of the ES-SCLC business to
achieve anticipated company profitability in the second half of
2025 and evaluating other myeloprotection uses for trilaciclib. We
are also pursuing ex-US partners to expand the use of COSELA®
(trilaciclib) globally.”
Financial Guidance
G1 today reaffirmed its full year 2024 COSELA net revenue
guidance and updated its cash runway guidance. G1's guidance is
based on current expectations for continued sales growth of COSELA
in the U.S. and achievement of its forecasts.
The Company expects to generate between $60 million and $70
million in COSELA net revenue in 2024. Additionally, G1 plans to
wind down the Phase 3 PRESERVE 2 trial, discontinue the anticipated
hiring of staff and investment for a 1L TNBC indication and make
targeted headcount reductions outside of the existing commercial
organization to streamline the Company. These efforts are expected
to provide sufficient cash runway to achieve anticipated company
profitability in the second half of 2025.
Webcast and Conference Call
G1 will host a webcast and conference call at 8:30 a.m. ET today
to discuss PRESERVE 2. Please note the following process to access
the call via telephone: To register and receive a dial in number
and unique PIN to access the live conference call, please follow
this link to register online. While not required, it is recommended
to join 10 minutes prior to the start of the event. A live and
archived webcast will be available on the Events &
Presentations page of the Company’s website:
www.g1therapeutics.com. The webcast will be archived on the same
page for 90 days following the event.
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). 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, expectations
with respect to future performance and development and
commercialization of our products, including our focus on
ES-SCLC and ex-US partnering on COSELA (trilaciclib), our
anticipated cash runway and profitability, and financial
guidance for full year 2024. Each of these forward-looking
statements involves significant risks and uncertainties that could
cause the actual results to differ materially from those discussed
in the forward-looking statements. 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 our filings with the U.S. Securities and Exchange
Commission, including the "Risk Factors" sections contained therein
and include, but are not limited to, our dependence on the
commercial success of COSELA (trilaciclib); the development and
commercialization of new drug products is highly competitive; our
ability to complete clinical trials for, obtain approvals for and
commercialize any of its product candidates; our 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. We
caution readers not to place undue reliance upon any
forward-looking statements, which speak only as of the date made.
Except as required by law, we assume 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
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