Summary
Bone marrow damage reduced for extended stage small cell lung cancer patients with newly FDA approved Cosela.
With Cosela, bone marrow damage is reduced for extended stage small cell lung cancer patients. The FDA approved trilaciclib (Cosela, G1 Therapeutics) as a first-in-class medication to reduce the frequency of chemotherapy-induced bone marrow damage (myelosuppression) in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer (ES-SCLC).
Bone Marrow Damage Reduced
“The approval of trilaciclib is an important advance in the treatment of patients with extensive-stage small cell lung cancer receiving chemotherapy,” said Jeffrey Crawford, MD, the George Barth Geller Professor for Research in Cancer in the Department of Medicine and Duke Cancer Institute, in Durham, N.C. It “provides the first proactive approach to myelosuppression through a unique mechanism of action that helps protect the bone marrow from damage by chemotherapy,” Crawford said. Trilaciclib may help protect bone marrow cells from damage by inhibiting the enzyme, cyclin-dependent kinase 4/6.
The indication for trilaciclib calls for administration before platinum/etoposide- or topotecan-containing regimens for adults with ES-SCLC. Trilaciclib should be given as a 30-minute IV infusion no more than four hours before chemotherapy administration to provide proactive, multilineage protection from chemotherapy-induced myelosuppression.
Effectiveness in Extended Stage Small Cell Lung Cancer Patients
The effectiveness of trilaciclib was evaluated in three randomized, double-blind, placebo-controlled studies in patients with ES-SCLC. Combined, these studies randomly assigned 245 patients to receive either an IV infusion of trilaciclib or a placebo before chemotherapy regimens containing carboplatin/etoposide (+/- atezolizumab) and topotecan. Approximately 90% of all patients with ES-SCLC will receive at least one of these regimens during the course of their treatment. The studies compared the two groups for the proportion of patients with severe neutropenia and the duration of severe neutropenia during the first cycle of chemotherapy.
In all three studies, patients who received trilaciclib had a lower chance of having severe neutropenia compared with patients who received a placebo. Among those who did develop severe neutropenia, the duration was shorter among trilaciclib patients, on average, than placebo patients.
The most common side effects of trilaciclib include fatigue; headache; pneumonia; decreased levels of calcium, potassium and phosphate; and increased levels of aspartate aminotransferase. Patients should also be advised about injection site reactions, acute drug hypersensitivity, interstitial lung disease/pneumonitis and embryo-fetal toxicity.
