G1 Therapeutics Announces Publication of Pooled Results from Pivotal Clinical Program of COSELA (trilaciclib) in Clinical Lung Cancer

- Pivotal Program Evaluated the Effects of Administering COSELA Prior to Chemotherapy on Clinically Relevant Endpoints Across Multiple Hematopoietic Lineages, Including Hematologic Adverse Events, Laboratory Values, and Use of Supportive Care Interventions -

- Compared with Placebo, Administering COSELA Prior to Chemotherapy Resulted in Significant Decreases in Most Measures of Multilineage Chemotherapy-Induced Myelosuppression (CIM), with a Reduction in the Incidence of Chemotherapy-Related Hematologic Adverse Events -

RESEARCH TRIANGLE PARK, N.C., April 26, 2021 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the peer-reviewed journal of Clinical Lung Cancer has published the final pooled results from three clinical trials of COSELA (trilaciclib) in extensive-stage small cell lung cancer (ES-SCLC). Compared with placebo, administering COSELA prior to chemotherapy resulted in significant decreases in most measures of multilineage chemotherapy-induced myelosuppression (CIM), with a reduction in the incidence of chemotherapy-related hematologic adverse events. The myeloprotective benefits of COSELA translated into a reduced need for supportive care interventions and hospitalizations due to CIM or sepsis, and improvements in health-related quality of life (HRQoL) domains, including fatigue, physical well-being, and functional well-being, with no impact on the antitumor efficacy of the individual chemotherapy regimens in ES-SCLC.

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.

The Clinical Lung Cancer publication, entitled Effects of Trilaciclib on Chemotherapy-Induced Myelosuppression and Patient-Reported Outcomes in Patients with Extensive-Stage Small Cell Lung Cancer: Pooled Results from Three Phase 2 Randomized, Double-Blind, Placebo-Controlled Studies (Weiss, J. et al.) can be found here.

“Cancer patients have two major sources of physical suffering - the cancer itself and the side effects of chemotherapy,” said Jared Weiss, MD, Associate Professor of Medicine, Division of Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina Chapel Hill, NC. “Small cell tends to present with bulky and rapidly growing central chest disease, which can compress airways and major vessels leading to shortness of breath, cough, and pain. While chemotherapy is great at shrinking the cancer and relieving these symptoms, it comes at the cost of side effects. The most common side effects from chemotherapy are suppression of blood counts and the consequences of that - neutropenia, anemia and fatigue. Trilaciclib helps decrease these side effects which can help optimize quality of life. With trilaciclib added to standard therapy, my patients experience less hematologic toxicity, a reduced need for supportive care interventions and hospitalizations due to CIM or sepsis, and ultimately improvements in health-related quality of life domains, including fatigue, and physical and functional well-being.”