FDA Approval Insights: Trilaciclib in Extensive-Stage Small Cell Lung Cancer

Welcome to OncLive On Air^TM! I’m your host today, Jessica Hergert.

OncLive On Air^TM is a podcast from OncLive, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions. 

Today, we had the pleasure of speaking with Jared Weiss, MD, an associate professor of medicine in the Division of Oncology and Department of Medicine at the University of North Carolina (UNC) School of Medicine, and associate director of finance in the UNC Lineberger Clinical Protocol Office at UNC Lineberger Comprehensive Cancer Center, to discuss the FDA approval of trilaciclib (Cosela) in extensive-stage small cell lung cancer (ES-SCLC).

On February 12, 2021, the FDA approved trilaciclib to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage SCLC.

Myelopreservation data from 3 randomized, double-blind, placebo-controlled clinical trials served as the basis for the regulatory decision. In each study, the first-in-class investigational therapy was given prior to or in conjunction with chemotherapy in patients with SCLC. In a pooled analysis of the studies, the administration of the CDK4/6 inhibitor prior to chemotherapy resulted in a significant reduction in most measures of multilineage chemotherapy-induced myelosuppression, as well as the need for supportive care interventions.

Overall survival and progression-free survival did not appear to be affected by the addition of trilaciclib, which was consistent with the hypotheses that were generated based on the agent’s mechanism of action, Weiss explained. Instead, trilaciclib can offer patients with SCLC improvement in chemotherapy-induced toxicities and quality of life, said Weiss.

In our exclusive interview, Weiss discussed the significance of the FDA approval of trilaciclib in extensive-stage small cell lung cancer and key efficacy and safety data that have been reported with the CDK4/6 inhibitor.