Gilead Sciences, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed following platinum-based chemotherapy. This designation highlights the potential of Trodelvy to address the urgent unmet medical needs of this patient population.
The Breakthrough Therapy Designation was awarded based on results from the global Phase 2 TROPiCS-03 study, specifically the ES-SCLC cohort. This study demonstrated encouraging results for Trodelvy as a second-line treatment for ES-SCLC. At the IASLC 2024 World Conference on Lung Cancer, data showed that Trodelvy exhibited promising antitumor activity in both platinum-resistant (PR) and platinum-sensitive (PS) disease subsets. Additionally, the safety profile observed in this study was consistent with prior Trodelvy trials. These findings support further investigation, and Gilead plans to launch a Phase 3 clinical trial to evaluate Trodelvy in this challenging indication.
Lung cancer remains the second most diagnosed cancer in the United States and is the leading cause of cancer-related deaths. Small cell lung cancer (SCLC) accounts for approximately 15% of lung cancer cases. Among these, nearly 70% are diagnosed at an extensive stage (ES), meaning the cancer has spread beyond one lung to lymph nodes, both lungs, or distant organs. Patients with ES-SCLC whose disease progresses after first-line treatment—typically platinum-based chemotherapy or immunotherapy—face a poor prognosis and have limited treatment options. This underscores the urgent need for new therapies that can extend survival and slow disease progression.
The FDA’s Breakthrough Therapy Designation aims to expedite the development and regulatory review of treatments for serious or life-threatening conditions. To qualify, treatments must show preliminary clinical evidence of substantial improvement over available therapies in significant clinical endpoints. This recognition marks the second Breakthrough Therapy Designation for Trodelvy, further emphasizing its potential as a transformative therapy for patients with critical unmet needs.
Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate (ADC) with a track record of delivering meaningful survival benefits in other cancer types. It is currently approved for treating certain metastatic breast cancers. Beyond breast cancer, Trodelvy is being evaluated across a broad spectrum of tumor types and disease stages in multiple Phase 3 trials. Gilead’s extensive research program also includes collaborations with academic institutions, industry partners, and the global oncology community to explore the full potential of Trodelvy in cancer care.
The TROPiCS-03 study’s ES-SCLC cohort demonstrated the significant promise of Trodelvy. The observed antitumor activity and manageable safety profile suggest it may be a valuable second-line treatment option for patients with ES-SCLC, a population with few alternatives after disease progression on current standards of care. These findings pave the way for further clinical trials and regulatory discussions to determine Trodelvy’s role in addressing this critical unmet need.
For patients with ES-SCLC, the prognosis is dire, with few effective treatment options available after progression on first-line therapies. Trodelvy’s potential to fill this gap in care is particularly significant. By combining targeted therapeutic action with the precision of antibody-drug conjugate technology, Trodelvy may offer new hope to patients facing this aggressive cancer.
Gilead’s commitment to innovation in oncology continues to drive its research efforts. The company is dedicated to improving outcomes for patients with difficult-to-treat cancers by advancing therapies like Trodelvy that leverage cutting-edge science and technology. With its growing portfolio of clinical trials and regulatory designations, Trodelvy represents a cornerstone of Gilead’s oncology pipeline and a beacon of hope for patients with limited treatment options.
Looking ahead, the planned Phase 3 trial for Trodelvy in ES-SCLC will build upon the strong foundation of the TROPiCS-03 study. This pivotal trial aims to confirm Trodelvy’s efficacy and safety in this population, potentially leading to broader regulatory approvals and expanded access for patients in need. Gilead remains committed to collaborating with the global cancer community to advance Trodelvy’s development and deliver transformative therapies that improve lives.
In summary, the FDA’s Breakthrough Therapy Designation for Trodelvy underscores its potential as a second-line treatment for ES-SCLC. With promising clinical results and ongoing efforts to explore its efficacy across diverse cancer types, Trodelvy stands as a testament to Gilead’s dedication to addressing unmet medical needs and shaping the future of cancer care.
