The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Trodelvy(sacituzumab govitecan-hziy) for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy treatment.
According to a news release from theTrodelvy manufacturer Gilead Sciences, Inc., the designation was based on findings among the ES-SCLC cohort of the phase 2 TROPiCS-03 study which investigated Trodelvy as a second-line treatment option for ES-SCLC.
Breakthrough therapy designation, according to the FDA, is meant to speed up the development and review of drugs intended to treat a serious condition. ES-SCLC, according to the American Cancer Society, has spread widely throughout the lung to the other lung or to other parts of the body.
Study results presented at the 2024 IASLC World Conference on Lung Cancer and published in the Journal of Thoracic Oncology showed that, at a median follow-up of 12.3 months, the treatment resulted in an overall response rate of 41.9%, with all responses being confirmed as partial responses. According to the news release, Gilead intends to launch a phase 3 clinical trial of Trodelvy among patients with ES-SCLC.
Trodelvy is an antibody-drug conjugate which targets TROP2, a cell surface antigen expressed in more than 90% of breast and lung cancers, according to the news release.
Antibody-drug conjugates consist of an antibody linked to a cytotoxic payload, such as a chemotherapy drug, and are a form of targeted therapy — in the case of Trodelvy, targeting cells that express TROP2.
Glossary
Overall response rate: Patients who responded partially or completely to treatment.
Boxed warning: The most serious warning the FDA can issue for a drug.
Neutropenia: A low count of neutrophils, a type of white blood cell.
Leukocyte: White blood cells.
Hemoglobin: Oxygen-carrying protein in red blood cells.
Lymphocyte: A type of white blood cell.
Albumin: A protein in the blood, low levels of which can indicate liver or kidney damage.
Decreased creatinine clearance: A potential indication of kidney disease.
Increased alkaline phosphatase: A potential indication of liver disease.
Trodelvy is currently indicated in the United States for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies and unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting, according to the announcement from Gilead.
Trodelvy comes with boxed warnings for neutropenia and diarrhea, with the company noting that severe or life-threatening neutropenia and severe diarrhea may occur. Neutropenia occurred in 64% of patients treated with Trodelvy, with grade 3 (severe) to 4 (life-threatening) occurring in in 49% of patients. Diarrhea occurred in 64% of patients who received Trodelvy, with grade 3 to 4 diarrhea occurring in 11% of patients.
Regarding side effects, the manufacturer stated that in the pooled safety population the most common side effects experienced by at least 25% of patients, including laboratory abnormalities, included decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%) and decreased sodium (26%).
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