G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology
company, today reported preliminary overall survival (OS) data from
the company’s randomized Phase 2 trial of trilaciclib in
combination with chemotherapy for the treatment of metastatic
triple-negative breast cancer (mTNBC). In the trial, median overall
survival for patients treated with trilaciclib in combination with
a chemotherapy regimen of gemcitabine/carboplatin (GC) was 20.1
months, compared with 12.6 months for patients receiving
chemotherapy alone. These data were reported as part of a
late-breaking oral presentation (LBA22) at the European Society for
Medical Oncology (ESMO) 2019 Congress and featured in a concurrent
publication in The Lancet Oncology.
Updated data from a separate randomized Phase 2 trial of
trilaciclib in small cell lung cancer (SCLC) will be presented
during a poster session (1742PD) on Sunday, September 29 at ESMO
2019 in Barcelona, Spain.
“Triple-negative breast cancer is the most aggressive form of
breast cancer and tends to have a poorer prognosis than other
breast cancers. We need new therapeutic approaches that improve
outcomes for women diagnosed with triple-negative breast cancer,”
said Joyce A. O'Shaughnessy, M.D., Baylor University Medical
Center, Texas Oncology, U.S. Oncology, and lead investigator for
the trial. “As an oncologist specializing in triple-negative breast
cancer, I am encouraged that trilaciclib has the potential to
improve the survival of patients diagnosed with this disease.”
“Trilaciclib is a first-in-class therapy that has improved
outcomes for people with cancer being treated with chemotherapy in
four randomized Phase 2 trials. The findings from these trials in
small cell lung cancer and triple-negative breast cancer indicate
that the clinical benefits of trilaciclib are meaningful and
context-dependent,” said Raj Malik, M.D., Chief Medical Officer and
Senior Vice President, R&D. “In metastatic triple-negative
breast cancer, the benefit manifests as improved overall survival.
In small cell lung cancer, patients experience myelopreservation
benefits, including reduced rates of neutropenia, anemia and other
chemotherapy-related side effects, and a corresponding decrease in
the use of rescue therapies required to address those toxicities.
Importantly, patient-reported outcome measures across all of our
trials showed that trilaciclib improved the patient experience on
chemotherapy.”
Mark Velleca, M.D., Ph.D., Chief Executive Officer, added:
“Based on feedback from our pre-NDA meeting with the FDA, we will
begin a rolling NDA submission for small cell lung cancer in the
fourth quarter of this year, which we expect to complete in the
second quarter of 2020. We have also had initial discussions with
the FDA regarding development of trilaciclib in triple-negative
breast cancer, including the preliminary design of a Phase 3 trial.
In 2020, we plan to initiate a Phase 3 trial in triple-negative
breast cancer and a Phase 3 trial in colorectal cancer, with the
goal of demonstrating the benefits of trilaciclib to patients
receiving chemotherapy for multiple tumor types.”
Overall survival benefit in mTNBCThe
randomized, open-label Phase 2 study (NCT02978716) of trilaciclib
in combination with GC, a current standard of care for TNBC,
enrolled 102 patients who had received up to two prior chemotherapy
regimens for locally recurrent or metastatic TNBC. In this
three-arm trial, all three groups received a chemotherapy regimen
of GC. Patients were randomized to receive GC only (Group 1) or GC
plus one of two dosing schedules of trilaciclib: trilaciclib
administered on the day of chemotherapy (Group 2) or trilaciclib
administered the day prior to and the day of chemotherapy (Group
3). Primary endpoints for the trial included myelopreservation
measures; secondary endpoints included additional myelopreservation
measures and anti-tumor efficacy measures of overall response rate
(ORR), progression-free survival (PFS) and OS. Myelopreservation
and preliminary anti-tumor efficacy results from the trial were
reported at the 2018 San Antonio Breast Cancer Symposium (press
release here). Topline OS findings were announced in June 2019
(press release here); detailed OS results were reported for the
first time at ESMO 2019.
Updated results from the trial showed:
• The addition of trilaciclib to chemotherapy
resulted in a significant increase in OS in both treatment groups
compared to chemotherapy alone.
- Compared to GC alone (Group 1), OS was improved for both
trilaciclib arms (Groups 2 and 3) with median OS of 12.6 months,
20.1 months and 17.8 months, respectively (Group 2: HR=0.33,
p=0.0283; Group 3: HR=0.34, p=0.0023). The median OS for Groups 2
and 3 combined was 20.1 months (HR=0.36, p=0.0015). The median OS
for GC alone (Group 1, 12.6 months) was consistent with historical
data.
• PFS and ORR were consistent with previously reported
data.• The safety and tolerability of
trilaciclib were consistent with previously reported
data.
- There have been no serious adverse events attributed to
treatment with trilaciclib in this trial.
• Patient-reported outcome (PRO) measures related to
anemia were improved in patients receiving trilaciclib versus
patients receiving chemotherapy alone.• As
previously reported, primary endpoints (myelopreservation measures)
were not met.
Trilaciclib in SCLCOn Sunday, September 29, G1
Therapeutics will present updated results from its randomized,
double-blind, placebo-controlled Phase 2 trial (NCT03041311)
evaluating trilaciclib in extensive-stage SCLC patients receiving
first-line chemotherapy and the checkpoint inhibitor Tecentriq®
(atezolizumab). The findings were consistent with previously
reported data (press release here):
- Trilaciclib demonstrated myelopreservation benefits, as shown
by statistically significant and clinically meaningful improvement
in reduction of myelosuppression endpoints, reduction of
chemotherapy side effects and reduction of rescue
interventions.
- Trilaciclib was well tolerated, with fewer ≥ Grade 3 adverse
events (AEs) compared to placebo.
- PRO measures related to anemia were improved in patients
receiving trilaciclib versus patients receiving placebo.
- Trilaciclib did not adversely impact chemotherapy anti-tumor
efficacy as measured by ORR, PFS and OS.
Additionally, data from another randomized Phase 1b/2 trial of
trilaciclib in patients with SCLC receiving first-line chemotherapy
were recently published in Annals of Oncology, the official journal
of ESMO. Data in this trial demonstrated the myelopreservation
benefits of trilaciclib as indicated by statistically significant
reduction in clinically relevant consequences of myelosuppression
compared to placebo, resulting in fewer supportive care
interventions and dose reductions. Trilaciclib did not adversely
impact the anti-tumor efficacy of chemotherapy.
Webcast and Conference Call Details G1
Therapeutics will host a webcast and conference call of its
investor and analyst event on Sunday, September 29, 2019,
at 6:45 p.m. CEST (12:45 p.m. ET) to review the data
being presented at ESMO 2019, as well as long-range
development plans for all three of its clinical-stage therapies and
commercial plans for trilaciclib. The live call may be accessed by
dialing 866-763-6020 (domestic) or 210-874-7713 (international) and
entering the conference code: 5878315. A live and archived webcast
will be available on the Events & Presentations page of the
company’s website at www.g1therapeutics.com. The webcast will
be archived on the same page for 90 days following the event.
About TrilaciclibTrilaciclib is a
first-in-class investigational therapy designed to improve outcomes
for people with cancer treated with chemotherapy. Based on results
from three randomized trials in patients with small cell lung
cancer, trilaciclib has received Breakthrough Therapy Designation,
and G1 Therapeutics expects to submit marketing applications in the
U.S. and Europe for myelopreservation in small cell lung cancer in
2020. In a randomized trial of women with metastatic
triple-negative breast cancer, trilaciclib improved overall
survival when administered in combination with chemotherapy
compared with chemotherapy alone. The company plans to initiate a
Phase 3 clinical trial in triple-negative breast cancer and a Phase
3 clinical trial in colorectal cancer in 2020.
About G1 TherapeuticsG1 Therapeutics, Inc. is a
clinical-stage biopharmaceutical company focused on the discovery,
development and delivery of innovative therapies that improve the
lives of those affected by cancer. The company is advancing three
clinical-stage programs. Trilaciclib is a first-in-class therapy
designed to improve outcomes for patients being treated with
chemotherapy. Trilaciclib has received Breakthrough Therapy
Designation from the FDA; a rolling NDA submission for small cell
lung cancer will begin in 4Q19 and is expected to be completed in
the second quarter of 2020. Lerociclib is a differentiated oral
CDK4/6 inhibitor designed to enable more effective combination
treatment strategies. G1T48 is a potential best-in-class oral
selective estrogen receptor degrader (SERD) for the treatment of
ER+ breast cancer. G1 Therapeutics also has an active discovery
program focused on cyclin-dependent kinase targets.
G1 Therapeutics is based in Research Triangle Park, N.C. For
additional information, please visit www.g1therapeutics.com and
follow us on Twitter @G1Therapeutics.
Forward-Looking StatementsThis 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 news release include, but are not limited to,
the therapeutic potential of trilaciclib, the timing for the
commencement and completion of marketing applications in the U.S.
and Europe for trilaciclib in SCLC, and plans to initiate
additional trials in colorectal cancer and TNBC, 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 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:Jeff MacdonaldSenior Director, Investor
Relations & Corporate
Communications919-907-1944jmacdonald@g1therapeutics.com
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