G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology
company, today announced the presentation of four posters that
provide new-real world evidence indicating that trilaciclib
administered prior to platinum-based chemotherapy in patients with
extensive-stage small cell lung cancer (ES-SCLC) lowers the rate of
hospitalization and cytopenia events and may improve survival. In
addition, multiple real-world analyses indicate the consistent
impact of chemotherapy-induced myelosuppressive events, including
severe neutropenia, thrombocytopenia, and anemia, on patients with
ES-SCLC being treated with platinum-based chemotherapy as well as
the resulting impact on healthcare resource utilization. The
posters are being presented at the 2023 American Society of
Clinical Oncology (ASCO) Quality Care Symposium, held October 27th
and 28th in Boston, MA. A copy of the posters will be made
available on the G1 Therapeutics website following the
presentations here.
“The burden of chemotherapy-induced myelosuppression not only
puts patients at risk for serious adverse events but can also
stress the healthcare system,” said Raj Malik, M.D., Chief Medical
Officer at G1 Therapeutics. “Findings from these real-world
analyses demonstrate the need to protect patients from the harmful
side effects of chemotherapy so that they can continue their
treatment. Trilaciclib offers the potential to transform the
treatment experience, and these new data underscore the results
we’ve seen across multiple analyses showing the positive impact of
proactive treatment with trilaciclib.”
The poster presentations include:
Myelosuppression and Healthcare Utilization Among
Patients with Chemotherapy-Treated Extensive-Stage Small Cell Lung
Cancer (ES-SCLC) with and without Trilaciclib from Community
Oncology Practices (Gajra, A. et
al.)
This observational study compared cytopenia-related outcomes and
HRU between patients with ES-SCLC who received trilaciclib prior to
chemotherapy vs. those who did not in a real-world setting. Using
the EMOL Health’s database, which includes >7 million patients
from >500 U.S. community oncology practices, structured
electronic medical records (EMRs) from January 2020 to April 2023
were examined for this study, supplemented by chart review.
Descriptive analyses were performed for patient baseline
characteristics and outcomes between the two matched cohorts.
Adjusted analyses were conducted to evaluate grade ≥3
myelosuppression in ≥1, ≥2, and all three lineages, as well as
all-cause hospitalization.
Results of this retrospective study suggest that patients
receiving trilaciclib prior to chemotherapy (n=77) in cycles 1-4
had lower rates of grade ≥3 myelosuppressive HAEs and
cytopenia-related HRU compared to the matched comparison cohort
(n=77) not treated with trilaciclib:
- 11.2% of trilaciclib-treated patients
had grade ≥3 HAEs in ≥1 lineage compared to 30.7% of patients in
the comparison cohort.
- 1.2% of trilaciclib-treated patients had grade ≥3 HAEs in ≥2
lineages compared to 13.5% of patients in the comparison
cohort.
- 0.4% of trilaciclib-treated patients had grade ≥3 HAEs in 3
lineages compared to 4.9% of patients in the comparison
cohort.
G-CSF administered any time during the cycle was reduced by
60.7% in patients receiving trilaciclib compared to those not
receiving trilaciclib in the comparison cohort (25.6% vs. 65.2%).
Similarly, RBC transfusions and erythropoiesis-stimulating agent
(ESA) use were reduced by 84.4% (1.7% vs. 10.9%) and 42.2% (3.7%
vs. 6.4%), respectively, in patients receiving trilaciclib compared
to those that did not.
After adjusting for age, sex, index line of therapy, and number
of chemotherapy cycles receiving trilaciclib, the odds of
developing an event of grade ≥3 myelosuppression in ≥1, ≥2, and 3
lineages were reduced by 70%, 90%, and 96%, respectively, with
trilaciclib use. All results were statistically significant. The
odds of all-cause hospitalization were reduced by 51% with
trilaciclib use, though not statistically significant.
Assessment of Hospitalizations and Cytopenia Events
Among Patients with Extensive Stage Small Cell Lung Cancer
(ES-SCLC) Receiving Chemotherapy with Trilaciclib (Huang,
H. et al.)
The goal of this study was to evaluate real-world rates of
hospitalizations and cytopenia-related outcomes in patients with
ES-SCLC treated with chemotherapy and trilaciclib, compared to
patients who did not receive trilaciclib. This retrospective study
used data from the 100% Medicare Fee-for-Service and the Inovalon
MORE2 closed claims databases between February 2020 and September
2023. Included in the study were 132 patients who received
trilaciclib prior to chemotherapy (and did not receive prophylactic
G-CSF) and 11,940 patients who did not receive trilaciclib.
Hospitalization Outcomes
- Patients receiving trilaciclib had a lower rate of all-cause
per patient per month (PPPM) hospitalizations during follow-up
(0.14±0.25 vs. 0.19±0.27; p<0.01) and were less likely to be
hospitalized within 90 days post-chemotherapy initiation (21.2% vs.
32.1%; p<0.01), compared to the patients who did not receive
trilaciclib.
Cytopenia Related Outcomes
- Compared to patients who did not receive trilaciclib, patients
receiving trilaciclib prior to their chemotherapy had a
statistically significantly lower risk of febrile neutropenia
(relative risk 15.5%, p=0.03) and numerically lower risk of anemia,
neutropenia and thrombocytopenia in the 90-day post-index
period.
Survival Outcomes
- Patients receiving trilaciclib had a numerically higher rate of
survival at six months (84.1%) compared to the non-trilaciclib
group (72.3%) and a survival hazard ratio of 0.63 (95% CI:
0.35-1.14, p=0.13) compared to patients not receiving
trilaciclib.
This real-world study suggests that trilaciclib administered
prior to chemotherapy was associated with lower rates of
hospitalizations and cytopenia events, along with an early trend
toward improved survival. Trilaciclib is an effective proactive
intervention to prevent adverse events associated with treatment
for ES-SCLC.
Burden of Myelosuppression in Extensive-Stage Small-Cell
Lung Cancer Patients Receiving Chemotherapy: Retrospective Analysis
of Real-World Data from Tennessee Oncology (Blakely, L.J.
et al.)
Using data from Tennessee Oncology (TNO), one of the largest
community-based cancer care specialists in the U.S., this study
evaluated the burden of myelosuppression as assessed by hematologic
adverse events (HAEs), including anemia, neutropenia, and
thrombocytopenia among patients with ES-SCLC treated with
chemotherapy (no trilaciclib). Additionally, it assessed
cytopenia-related and all-cause healthcare resource use (HRU) among
the same population.
The retrospective analysis followed 152 ES-SCLC patients who
received chemotherapy (with or without immunotherapy) but did not
receive trilaciclib at any point in their therapy. Among these
patients, the prevalence of single and multi-lineage
myelosuppression during follow up period (10 month average
follow-up period after initiation of chemotherapy) was as
follows:
- 63.8% had grade ≥ 3 myelosuppressive HAE in ≥ 1 lineage.
- 49.3% had grade ≥ 3 neutropenia, 29.0% had grade 3 anemia, and
28.3% had grade ≥ 3 thrombocytopenia.
- 32.2% had grade ≥3 HAEs in ≥2 lineages.
- 10.5% had grade ≥3 HAEs in 3
lineages.
Cytopenia-related and all-cause healthcare resource use (HRU)
during follow up period included:
- 76.3% of patients received granulocyte colony-stimulating
factor (G-CSF) administration at any time during
follow-up.
- 30.3% received a red blood cell (RBC) transfusion.
- 57.9% experienced at least one inpatient admission.
- 67.8% experienced at least one emergency room visit.
- 100% experienced at least one outpatient visit.
These results suggest that, consistent with other published
studies, there is high patient burden associated with traditional
management of myelosuppression in patients with ES-SCLC in a
community oncology practice like TNO, indicating an unmet need in
this population. Therapies that protect bone marrow from
myelosuppression have potential to reduce such burden.
Patient Characteristics Associated with Myelosuppression
Among Patients with Extensive-Stage Small Cell Lung Cancer Treated
with Chemotherapy in The Community Oncology Setting (Goldschmidt,
J. et al.)
This retrospective observational study examined the association
between patient attributes and the risk of chemotherapy-induced
myelosuppression in patients with ES-SCLC, utilizing real-world
data from the U.S. Oncology Network’s iKnowMed (iKM) electronic
health record system.
This study found that all patients with ES-SCLC are at a similar
risk of myelosuppressive events, irrespective of patient
characteristics (age, sex, race, ECOG performance status) and
baseline lab values (hemoglobin, ANC, or platelet count), which
were not found to be risk factors for myelosuppressive events for
ES-SCLC patients receiving chemotherapy. Chemotherapy intensity and
prophylactic management had a more prominent role in risk of
myelosuppression. Additionally, the study found that treatment
delays and holds are associated with a higher risk of
myelosuppressive events. These findings suggest that how patients
present in their initial visits are not necessarily predictive of
myelosuppressive events.
About Small Cell Lung CancerIn the United
States, approximately 30,000 small cell lung cancer patients are
treated annually. SCLC, one of the two main types of lung cancer,
accounts for approximately 14% of all lung cancers. SCLC is an
aggressive disease and tends to grow and spread faster than NSCLC.
It is usually asymptomatic; once symptoms do appear, it often
indicates that the cancer has spread to other parts of the body.
About 70% of people with SCLC will have cancer that has
metastasized at the time they are diagnosed. The severity of
symptoms usually increases with increased cancer growth and spread.
From the time of diagnosis, the general 5-year survival rate for
people with SCLC is 6%. The five-year survival rates for
limited-stage (the cancer is confined to one side of the chest)
SCLC is 12% to 15%, and for extensive stage (cancer has spread to
the other lung and beyond), survival rates are less than 2%.
Chemotherapy is the most common treatment for ES-SCLC.
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 development plan
evaluating trilaciclib in a variety of solid tumors, including
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 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,"
"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, the need to protect patients from the harmful side
effects of chemotherapy and the potential of trilaciclib to
transform the treatment experience 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; 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.
G1 Therapeutics Contacts:
Will RobertsVice President, Investor Relations & Corporate
Communications919-907-1944 wroberts@g1therapeutics.com
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