GTHX G1 Therapeutics Inc

G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today presented two scientific posters at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) describing the estimated economic impact of treating myelosuppression among patients with extensive-stage small cell lung cancer. The posters are available in the scientific publications section of the G1’s website.

COSELA was approved by the U.S. Food and Drug Administration on February 12, 2021 to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC.

Cost-Benefit Analysis of Trilaciclib for the Prevention of Chemotherapy-Induced Myelosuppression in Extensive-Stage Small Cell Lung Cancer (Deniz, B. et al.) (poster)

The first poster details a cost-benefit model estimating the economic value from a U.S. commercial payer perspective of using COSELA™ (trilaciclib) prior to chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC). According to the model, the estimated potential total cost savings per patient is $15,006 – savings that are based on a projected reduction in myelosuppressive adverse events (AEs) and their associated treatment costs. The authors attributed this cost saving, in part, to data from previous trials indicating that use of COSELA prior to chemotherapy was associated with fewer myelosuppressive AEs: 0.6 AEs per patient with COSELA compared to 2.7 myelosuppressive AEs per patient without COSELA.  

Overall, the authors suggested that the model indicates that COSELA could be an economically favorable innovation when addressing the incidence of myelosuppression in patients with ES-SCLC receiving a platinum/etoposide-containing chemotherapy regimen.

Trends in Prevalence, Treatment Patterns, Myelosuppression, and Burden on the Health Care System Among Patients with Small Cell Lung Cancer: A SEER-Medicare Analysis (Epstein, R. et al.) (poster)

The second poster quantifies the impact of treatment-induced myelosuppression among Medicare patients diagnosed with SCLC, thereby contributing to the growing body of scientific evidence demonstrating the significant health burden, economic toll, and health-related quality-of-life effects of chemotherapy-induced myelosuppression. The presented findings — among the first to evaluate healthcare utilization in a SEER Medicare-linked data set of SCLC patients — provided an epidemiologic assessment quantifying the real-world prevalence, treatment patterns and healthcare burden of myelosuppression prior to the availability of COSELA.

Among the findings of this SEER Medicare epidemiologic study:

• Nearly three-quarters of chemotherapy-treated patients experienced anemia during the timeframe studied (2012 to 2015);
• Neutropenia was reported in 45.2% of chemotherapy-treated patients overall;
• Thrombocytopenia was reported in 27.0% of chemotherapy-treated patients overall;
• Pancytopenia was reported in 24.4% of patients overall; and
• During the same period, 74.3% of chemotherapy-treated patients experienced at least one inpatient admission associated with myelosuppression.

“Chemotherapy remains a cornerstone of treatment for SCLC, and chemotherapy-induced myelosuppression is a frequent complication that may manifest as neutropenia, anemia, and/or thrombocytopenia,” said Marc Chioda, PharmD, G1’s Vice President of Medical Affairs and co-author of both posters. “These analyses add to the data that help clarify the potential positive financial impact of COSELA usage and the projected real-world economic value of COSELA. Together, these data suggest that use of COSELA should be a favorable economic strategy in the first line of therapy compared with standard care.”

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 about 10% to 15% 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 COSELA™ (trilaciclib) for Injection

IndicationCOSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021. COSELA™ (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety InformationCOSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

Please click here for full Prescribing Information. https://www.g1therapeutics.com/cosela/pi/   

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

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, those relating to expectations for the commercial launch of COSELA (trilaciclib), the therapeutic potential of COSELA (trilaciclib), and COSELA’s (trilaciclib) possibility to realize the economic impact in the US market presented in the scientific analyses described above, and COSELA (trilaciclib) may fail to achieve the degree of market acceptance for commercial success, 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 a successful commercial launch for COSELA (trilaciclib); the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates other than COSELA (trilaciclib); 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 RobertsVice President, Investor Relations & Corporate Communications919-907-1944 wroberts@g1therapeutics.com