G1 Therapeutics Announces Publication of Pooled Results from Pivotal Clinical Program of COSELA (trilaciclib) in Clinical Lung Cancer - Seite 2

Data from three randomized, double-blind, placebo-controlled studies were pooled to evaluate the effects of COSELA administered prior to standard-of-care chemotherapy in patients with ES-SCLC. The primary endpoints were duration of severe neutropenia (DSN) in cycle 1, and occurrence of severe neutropenia (SN). Additional prespecified endpoints further assessed the effect of COSELA on myeloprotection, HRQoL, antitumor efficacy, and safety.

Of 242 randomized patients, 123 received COSELA and 119 received placebo. Compared with placebo, administration of COSELA prior to chemotherapy resulted in significant decreases in most measures of multilineage CIM. For example, statistically significant improvements in the primary endpoints of duration of severe neutropenia in cycle 1 and occurrence of severe neutropenia were observed in the COSELA group versus the placebo group. Mean (standard deviation) DSN in cycle 1 was 0 days (1.8) with COSELA versus 4 days (5.1) with placebo (P < 0.0001), and throughout the treatment period, 14 (11.4%) patients in the COSELA group had SN versus 63 (52.9%) patients in the placebo group (P < 0.0001). Most secondary myelosuppression endpoints, including the percentage of patients with G-CSF administration, grade 3/4 anemia, RBC transfusions on/after week 5 of study treatment, ESA administrations, and grade 3/4 thrombocytopenia also significantly favored COSELA over placebo.

The reduction in hematologic toxicity translated into the reduced need for supportive care interventions and hospitalizations due to CIM or sepsis, and improvements in HRQoL domains related to the protected cell lineages, including physical and functional wellbeing, symptoms and impact of fatigue, and the symptoms and effects on physical and functional wellbeing due to anemia as reported in the patient reported outcome data.

The authors concluded that administering COSELA prior to chemotherapy resulted in clinically meaningful reductions in CIM and its consequences, and improved patient HRQoL, with no impact on the antitumor efficacy of three individual chemotherapy regimens used in the first- or second-/third-line treatment of ES-SCLC.

About COSELA (trilaciclib)

COSELA^TM (trilaciclib) is the first and only myeloprotection therapy to help decrease the incidence of chemotherapy-induced myelosuppression. Administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy, COSELA helps proactively deliver multilineage myeloprotection to patients with extensive-stage small cell lung cancer (ES-SCLC) being treated with chemotherapy. COSELA 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 ES-SCLC.