New Study Confirms Consistent Risk of Myelosuppression Across All Patients Receiving Chemotherapy for Small Cell Lung Cancer

Real-World Data Show No Association Between Patient Characteristics and Risk of Myelosuppressive Events

RESEARCH TRIANGLE PARK, N.C., May 16, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today described recently presented real-world data that confirm a consistent risk of myelosuppressive events (neutropenia, anemia, thrombocytopenia) across patients with small cell lung cancer (SCLC) being treated with chemotherapy. These findings were presented in a poster session at the 2023 meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), held May 7-10, 2023.

“Chemotherapy remains an effective cornerstone treatment for patients with small cell lung cancer; unfortunately, chemotherapy-induced myelosuppression is a known common and debilitating complication associated with these cytotoxic regimens,” said Norman Nagl, Ph.D., Vice President of Medical Affairs at G1 Therapeutics. “Despite this, little data have been generated in this tumor type to help clarify and quantify the risk of myelosuppressive events across the spectrum of patients who are treated with chemotherapy for SCLC. For the first time, the results of these analyses show that all patients - of any age, gender, race, stage, ECOG or smoking status, or at any line of chemotherapy - are at similarly high risk for such myelosuppressive events. This continues to underscore the need to ensure that patients receive the most appropriate therapies to reduce that risk and to help improve their chemotherapeutic experience.”

Results showed that, among adult patients in this data set diagnosed with SCLC who received chemotherapy, grade ≥3 myelosuppression occurred in 60.9% of patients in the overall population. Further, more than half of the patients experienced grade ≥3 myelosuppression in all subgroups among the overall population, except one subgroup of patients for whom their SCLC stage was not documented at diagnosis (n=15). Multivariate regression analyses identified no significant associations between patient characteristics and myelosuppression; similar findings were observed in age-specific and lineage-specific regression models.

The poster, titled, “An Analysis of Patient Characteristics Associated With Myelosuppression Among Small Cell Lung Cancer Patients Treated in US Community Cancer Care Practices” is available in the scientific publications section of G1’s website.

Study Design
This retrospective observational study used the electronic medical records (EMR) data from the Providence St. Joseph Health (PSJH) and the Providence Cancer Reporting Registry, which included data from 40 oncology clinics associated with community hospitals across seven U.S. states. Adult patients diagnosed with SCLC who received chemotherapy between 2016 and 2018 and had longitudinal laboratory data were included in this study. Patients were followed from the date of the first chemotherapy dose for 12 months, or until the date of the last visit, date of death, or the end of the study period (December 2019), whichever occurred earliest. Percentages of patients with grade ≥3 myelosuppression and grade ≥3 lineage-specific cytopenia were analyzed by patient characteristics. Multivariate logistic regressions were conducted to examine the association between patient characteristics (independent variable) and risk of experiencing at least one grade ≥3 myelosuppression (dependent variable) among the overall population and by age group. In addition, multivariate logistic regressions were conducted to examine association between patient characteristics and risk of myelosuppression in each lineage (anemia, neutropenia, thrombocytopenia).

About Small Cell Lung Cancer
In 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 Therapeutics
G1 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 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, the associations between characteristics of SCLC patients being treated with chemotherapy and myelosuppression, the expectations for further real-world data to support the current observation of consistent risk of myelosuppressive events across SCLC patients being treated with chemotherapy, the need for treatment to reduce the risk of myelosuppressive events, and the company’s ability to help improve the chemotherapeutic experience of patients with SCLC, 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 Contact:

Will Roberts
Vice President, Investor Relations & Corporate Communications
919-907-1944
wroberts@g1therapeutics.com