Sutro Biopharma Starts Phase 2 Trial of Luvelta for Non-Small Cell Lung Cancer

SOUTH SAN FRANCISCO, CA, USA I August 22, 2024 I Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology enterprise renowned for pioneering site-specific and novel-format antibody drug conjugates (ADCs), has announced the commencement of REFRαME-L1, a global Phase 2 study of luveltamab tazevibulin (luvelta). This study targets patients with non-small cell lung cancer (NSCLC) whose tumors express Folate Receptor-α (FRα) and is now open for enrollment. Initial data from this trial are anticipated in the first half of 2025.

Anne Borgman, M.D., Chief Medical Officer at Sutro, highlighted the significance of this milestone, emphasizing the potential of luvelta to serve a wide range of patients with FRα expressing cancers. She stated that preclinical evidence suggests luvelta could represent an essential new treatment avenue for NSCLC, particularly due to its precise design, broad therapeutic window, and ability to treat patients with lower FRα expression profiles.

Lung cancer remains the leading cause of cancer-related deaths globally. A significant portion of patients are diagnosed with metastatic disease, which has a 5-year survival rate as low as 8%. Despite various treatment strategies, many patients with advanced NSCLC eventually develop resistance to treatments, limiting their options as the disease progresses.

FRα has been detected in various cancer types, including NSCLC, but its expression in normal tissue is minimal. Approximately 30% of patients with adenocarcinoma NSCLC exhibit FRα expression, making it an attractive target for advanced NSCLC therapy and offering patients a chance for targeted treatment.

The REFRαME-L1 trial is set to evaluate the safety and efficacy of luvelta in adult patients with previously treated advanced or metastatic NSCLC with FRα expression ≥25% Tumor Proportion Score (TPS). The planned dosing regimen is 4.3 mg/kg of luvelta every three weeks.

Luveltamab tazevibulin, commonly referred to as luvelta and previously known as STRO-002, is an FRα-targeting ADC created to treat a diverse range of patients with ovarian cancer. This includes those with lower FRα-expression who are ineligible for approved FRα-targeting treatments. Utilizing Sutro’s cell-free XpressCF® platform, luvelta is crafted as a homogeneous ADC featuring four hemiasterlin cytotoxins per antibody. This precise configuration ensures efficient tumor targeting while maintaining systemic stability post-dosing. 

Additionally, Sutro is conducting the REFRαME-O1, a Phase 2/3 registration-directed study for patients with platinum-resistant ovarian cancer. The company is also running trials for patients with endometrial cancer, NSCLC, and in combination with bevacizumab for ovarian cancer. Sutro plans to initiate REFRαME-P1, a Phase 2/3 registration-directed study for patients with CBF/GLIS2 acute myeloid leukemia, a rare pediatric cancer subtype, in the latter half of 2024. The U.S. Food and Drug Administration (FDA) has granted luvelta a Fast Track designation for ovarian cancer, as well as Orphan and Rare Pediatric Disease designations for CBF/GLIS2 Pediatric AML.

Sutro Biopharma, Inc. is a clinical-stage company dedicated to the discovery and development of meticulously designed cancer therapeutics. Their innovative technology, including the cell-free XpressCF® platform, aims to provide broader patient benefits and improved patient experiences. With multiple clinical-stage candidates, including luveltamab tazevibulin, Sutro continues to drive product innovation supported by valuable collaborations and industry partnerships. The company is headquartered in South San Francisco.

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