Gilead Sciences Discovers Trodelvy® for Extensive-Stage Small Cell Lung Cancer
Gilead Sciences has developed Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed after platinum-based chemotherapy.
Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2, a cell surface antigen, is highly expressed in various tumour types, including more than 90 percent of breast and lung cancers.
The drug is designed with a proprietary hydrolysable linker attached to SN-38, a topoisomerase I inhibitor payload. This innovative combination delivers potent activity to Trop-2-expressing cells and the tumour microenvironment through a bystander effect.
Clinical trials have shown promising antitumor activity for Trodelvy in both platinum-resistant (PR) and platinum-sensitive (PS) cases, with a safety profile consistent with earlier studies of the drug.
Lung cancer is the second most commonly diagnosed cancer in the U.S. and the leading cause of cancer-related deaths. About 15 percent of lung cancer cases are SCLC, with nearly 70 percent of these diagnosed at the extensive stage—when the cancer has spread to both lungs or other organs.
For patients with ES-SCLC whose disease does not respond to current first-line therapies (platinum-based chemotherapy or immunotherapy), the prognosis is often poor, and treatment options are limited. This underscores the urgent need for more effective treatments to improve survival rates and slow disease progression.
Trodelvy has received approval in over 50 countries for the treatment of metastatic triple-negative breast cancer (TNBC) in second-line or later settings and in more than 40 countries for patients with pre-treated HR+/HER2- metastatic breast cancer.
The U.S. FDA has granted Breakthrough Therapy Designation to Trodelvy for the second-line treatment of ES-SCLC.
