FDA Approves G1 Therapeutics' Cosela to Prevent Chemo Damage in Lung Cancer

The U.S. Food and Drug Administration (FDA) approved G1 Therapeutics’ Cosela (trilaciclib) for injection to decrease the damage to the immune system and bone marrow from chemotherapy. Specifically, to decrease the incidence of chemotherapy-induced myelosuppression in adults receiving a platinum/etoposide-containing or topotecan-containing chemotherapy regimen for extensive-stage small cell lung cancer (ES-SCLC).

The drug had previously been granted priority review from the FDA. It also inked a three-year co-promotion deal for the drug in the U.S. and Puerto Rico with Boehringer Ingelheim in June 2020.

“The approval of trilaciclib (Cosela) is an important advance in the treatment of patients with extensive-stage small cell lung cancer receiving chemotherapy,” said Jeffrey Crawford, Geller Professor for Research in Cancer in the Department of Medicine and Duke Cancer Institute. “The most serious and life-threatening side effect of chemotherapy is myelosuppression, or damage to the bone marrow, resulting in reduced white blood cells, red blood cells and platelets. Chemotherapy-induced myelosuppression may lead to increased risks of infection, severe anemia, and/or bleeding.”

Trilaciclib is a first-in-class FDA-designated “Breakthrough Therapy.” In addition to SCLC, the drug is being evaluated across a range of tumor types and chemotherapy regimens, including in colorectal cancer and metastatic triple-negative breast cancer.

On December 9, 2020, the company reported final data from its Phase II trial of Trilaciclib in metastatic triple-negative breast cancer. The drug demonstrated significantly improved overall survival (OS) for patients receiving the drug in combination with a chemotherapy regimen of gemcitabine/carboplatin (GC) compared to GC alone.

Chemotherapy works well in treating cancer, but the process is basically poisoning cells—but it affects faster-growing cells first. But it doesn’t spare healthy cells, killing both, including hematopoietic stem and progenitor cells (HSPCs) found in the bone marrow that manufacture white blood cells used by the immune system, red blood cells, and platelets. This chemotherapy-induced damage is known as myelosuppression and can cause increased risk of infection, anemia, thrombocytopenia, and other health complications.

“Chemotherapy is the most effective and widely used approach to treating people diagnosed with extensive-stage small cell lung cancer; however, standard of care chemotherapy regimens are highly myelosuppressive and can lead to costly hospitalizations and rescue interventions,” said Jack Bailey, chief executive officer of G1. “Cosela will help change the chemotherapy experience for people who are battling ES-SCLC. G1 is proud to deliver Cosela to patients and their families as the first and only therapy to help protect against chemotherapy-induced myelosuppression.”

The drug is given intravenously as a 30-minute infusion within four hours ahead of the start of chemotherapy. It’s the first FDA-approved therapy that can offer proactive, “multilineage protection” from myelosuppression caused by chemotherapy.

The approval was built on data from three trials where the drug given ahead of chemotherapy demonstrated a clinically meaningful and statistically significant decrease in the duration and severity of neutropenia, which is an abnormally low neutrophil count, a type of white blood cell. It also demonstrated a positive impact on red blood cell transfusions and other myeloprotective measurements.

The studies evaluated Cosela in combination with carboplatin-etoposide, with or without the immunotherapy Genentech’s Tecentriq (atezolizumab) and topotecan chemotherapy. About 90% of all ES-SCLC patients will be given at least one of those chemotherapy treatments during the course of their therapy.

Most adverse reactions from Cosela were mild to moderate. The most common were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia. About 30% of patients had serious adverse reactions. More than 3% of patients receiving Cosela had respiratory failure, hemorrhage, and thrombosis.

“Quite often, people diagnosed with extensive-stage small cell lung cancer rely on chemotherapy to not only extend their lives, but also to acutely alleviate their symptoms,” said Bonnie J. Addario, co-founder and board chair of the Go2 Foundation for Lung Cancer. “Unfortunately, the vast majority will experience chemotherapy-induced side effects, resulting in dose delays and reductions, and increased utilization of healthcare services. G1 shares our organization’s goal to improve the quality of life of those diagnosed with lung cancer and to transform survivorship among people living with this insidious disease. We are thrilled to see new advancements that can help improve the lives of those living with small cell lung cancer.”