Trodelvy Receives FDA Breakthrough Therapy Designation for ES-SCLC
Key Insights
The FDA granted Breakthrough Therapy Designation to Trodelvy (sacituzumab govitecan-hziy) for treating extensive-stage small cell lung cancer (search) (ES-SCLC (search)) after platinum-based chemotherapy.
Phase 2 TROPiCS-03 study results showed Trodelvy demonstrated promising antitumor activity in both platinum-resistant and platinum-sensitive ES-SCLC (search), supporting the designation.
Gilead plans to initiate a Phase 3 clinical trial to further investigate Trodelvy's efficacy in ES-SCLC (search) patients, addressing a critical unmet need in this population.
Gilead Sciences' Trodelvy (sacituzumab govitecan-hziy) has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer (search) (ES-SCLC (search)) whose disease has progressed on or after platinum-based chemotherapy. This decision aims to expedite the development and review of Trodelvy for this serious condition, where limited treatment options are available.
The FDA's designation is based on encouraging results from the global Phase 2 TROPiCS-03 study ES-SCLC (search) cohort. The study evaluated Trodelvy as a second-line treatment for ES-SCLC, demonstrating promising antitumor activity in both platinum-resistant and platinum-sensitive disease. The safety profile observed was consistent with previous Trodelvy studies.
TROPiCS-03 Study Results
Data presented at the IASLC 2024 World Conference on Lung Cancer (search) showed an overall response rate (ORR) of 41.9% in patients treated with Trodelvy, with all responses being confirmed as partial responses. The study, with a median follow-up of 12.3 months, also revealed a disease control rate of 83.7%. These findings suggest that Trodelvy could offer a significant benefit to patients with ES-SCLC (search) who have limited treatment options after platinum-based chemotherapy.
Afshin Dowlati, MD, professor at Case Western Reserve University School of Medicine, highlighted the limited treatment options for relapsed SCLC and noted the promising efficacy of sacituzumab govitecan as a second-line treatment. The data supports further investigation in a randomized phase 3 study.
Addressing Unmet Needs in ES-SCLC
Lung cancer (search) is the second most diagnosed cancer in the U.S. and the leading cause of cancer-related deaths. Small cell lung cancer (search) (SCLC) accounts for approximately 15% of lung cancer cases, with nearly 70% of patients diagnosed at the extensive stage. The prognosis for patients with ES-SCLC (search) whose disease does not respond to current first-line standard of care (platinum-based chemotherapy or immunotherapy) is often poor, underscoring the urgent need for new and more effective approaches.
About Trodelvy
Trodelvy is a first-in-class Trop-2 (search)-directed antibody-drug conjugate (ADC). Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment.
Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (search) (TNBC (search)) and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer. It is also being investigated for use in other TNBC and HR+/HER2- breast cancer populations, as well as a range of tumor types where Trop-2 (search) is highly expressed, including small cell lung cancer (search) and first-line metastatic non-small cell lung cancer.
Safety Profile
Trodelvy carries boxed warnings for neutropenia and diarrhea. Severe or life-threatening neutropenia may occur, requiring monitoring of blood cell counts and potential dose modification. Diarrhea is also a common side effect, necessitating monitoring and prompt management with loperamide and fluid/electrolyte replacement.
Gilead's Plans
Gilead plans to initiate a Phase 3 clinical trial to further investigate Trodelvy's efficacy in patients with ES-SCLC (search). This trial will provide more definitive data on the potential of Trodelvy to improve outcomes in this challenging disease.