G1 Therapeutics Initiates PRESERVE 3, A Randomized Phase 2 Study of COSELA™ (trilaciclib) in Bladder Cancer
June 14 2021 - 7:00AM
G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today announced that the Company has initiated PRESERVE 3,
a Phase 2, randomized, open-label study of COSELA™ (trilaciclib)
administered with first-line platinum-based chemotherapy and the
immune checkpoint inhibitor avelumab maintenance therapy in
patients with untreated, locally advanced or metastatic urothelial
carcinoma (mUC). Myeloprotection and anti-tumor efficacy endpoints
are being assessed in this study. Initial results of this study are
expected in the second half of 2022.
“Bladder cancer is unfortunately common and the five-year
survival rate for metastatic urothelial carcinoma has not changed
in the last 25 years, highlighting the need for new and well
tolerated therapies specifically tailored for immune sensitive
tumors like this,” said Raj Malik, M.D., Chief Medical Officer at
G1 Therapeutics. “While chemotherapy followed by avelumab
maintenance therapy has proven to be a meaningful step forward for
the 1L treatment of patients with mUC, patients may not receive the
maximal benefit for a variety of reasons. These Phase 2 data will
be instructional and important to evaluate the benefit of adding
COSELA to this regimen, and if positive, would be quickly followed
by a Phase 3 registrational trial.”
Patient recruitment in Preserve 3 is now underway. The study
will enroll approximately 90 patients, who will be randomly
assigned (1:1) to one of two treatment arms (A or B). Arm A will
receive gemcitabine/platinum chemotherapy followed by avelumab
maintenance therapy. Arm B will receive COSELA prior to
gemcitabine/platinum chemotherapy followed by COSELA plus avelumab
maintenance therapy. Standard of care gemcitabine/platinum
chemotherapy (with or without the addition of COSELA) will be
administered intravenously in 21-day cycles and standard of care
avelumab maintenance therapy (with or without the addition of
COSELA) will be administered intravenously in 14-day cycles. There
will be two stratification factors for randomization: presence of
visceral metastasis (yes or no), and initial platinum-based
chemotherapy to be administered (cisplatin or carboplatin).
Patients enrolled in the study will be eligible to receive 4 to
6 cycles of platinum-based chemotherapy. Patients without
progressive disease as per Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1 guidelines (i.e., with an ongoing complete
response, partial response, or stable disease) after platinum-based
chemotherapy will be eligible to receive avelumab maintenance
therapy (with or without COSELA) until disease progression,
unacceptable toxicity, withdrawal of consent, Investigator
decision, or the end of the trial, whichever occurs first.
The primary endpoint is to evaluate the anti-tumor efficacy of
COSELA when combined with platinum-based chemotherapy and the
checkpoint inhibitor avelumab maintenance therapy as measured by
progression-free survival (PFS) during the overall study. Key
secondary endpoints include:
- evaluation of the anti-tumor
efficacy of COSELA as measured by the objective response rate
(ORR);
- disease control rate;
- duration of objective response
(DOR);
- PFS in the maintenance period;
- overall survival (OS) and
probability of survival (POS) at Month 16;
- evaluation of the myeloprotective
effects of COSELA on chemotherapy-induced myelosuppression;
and
- assessment of the safety and
tolerability of COSELA in patients receiving platinum-based
chemotherapy followed by avelumab maintenance therapy.
G1 announced in February 2021 that it had entered into a
clinical trial collaboration with the alliance between Merck KGaA,
Darmstadt, Germany and Pfizer whereby the alliance will contribute
clinical supply of the checkpoint inhibitor avelumab to this
first-line treatment of mUC trial.
About Bladder CancerBladder cancer is the most
common malignancy involving the urinary system and is the sixth
most common cancer in the United States. The American Cancer
Society estimates that approximately 84,000 new cases of bladder
cancer will be diagnosed in the U.S. in 2021. Approximately 2.4% of
the US population will be diagnosed with bladder cancer at some
point during their lifetime; the average age at diagnosis is 73
years and it is rarely diagnosed in people less than 40 years of
age. Urothelial carcinoma, also known as transitional cell
carcinoma (TCC), urothelial bladder cancer, or urothelial cell
carcinoma (UCC) of the urinary tract, is the most common type of
bladder cancer in the U.S. and Europe, where it accounts for 90% of
all bladder cancers. It also accounts for up to 15%
of kidney cancers diagnosed in adults. The overall 5-year
survival rate for metastatic urothelial carcinoma is approximately
5.5%, which has remained unchanged over the past 25 years.
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 in this Phase 2 trial of COSELA in bladder cancer,
the stated primary and secondary endpoints may not achieve
statistical significance, delays in the enrollment of patients in
this trial of COSELA may delay or prevent our plans, COSELA may
fail to achieve the degree of market acceptance for commercial
success, and 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
G1 Therapeutics (NASDAQ:GTHX)
Historical Stock Chart
From Aug 2024 to Sep 2024
G1 Therapeutics (NASDAQ:GTHX)
Historical Stock Chart
From Sep 2023 to Sep 2024