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Sutro Biopharma STRO, a clinical-stage company, is focused on developing novel antibody drug conjugates or ADC candidates using its proprietary drug development platforms to treat several oncology indications. The company’s pipeline comprises only one candidate, luveltamab tazevibulin or luvelta (formerly known as STRO-002), which is being developed for various FRα-expressing cancers.
Sutro Biopharma’s shares gained 8.9% in the past week after the company announced that it has begun enrollment in its global phase II REFRαME-L1 study of luvelta for patients with non-small cell lung cancer (NSCLC) whose tumor expresses FRα.
Management claims that luvelta is differentiated from currently available treatment options for the above indication due to its precise design, wide therapeutic window and ability to treat patients with lower FRα expression profiles, offering patients a chance for targeted therapy.
Year to date, shares of Sutro Biopharma have gained 16.8% compared with the industry’s 1.4% growth.
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The planned REFRαME-L1 study will evaluate the safety and efficacy of luvelta in adult patients with previously treated advanced or metastatic NSCLC with FRα expression ≥25% Tumor Proportion Score. The expected dosing regimen in the study will be 4.3 mg/kg of luvelta every three weeks. Top-line results from the lung cancer study are anticipated in the first half of 2025.
Lung cancer is the primary cause of cancer-related deaths globally. Most advanced NSCLC patients face a very poor prognosis. Despite various treatment approaches, the majority of these patients eventually develop resistance to treatments, leading to fewer available options as the disease progresses to later stages. Per Sutro Biopharma, approximately 30% of patients with adenocarcinoma NSCLC have FRα expression.
Please note that luvelta is primarily being developed for a broad range of patients with ovarian cancer, including those with lower FRα-expression who are not eligible for approved treatment options targeting FRα. An ongoing mid to late-stage, registration-directed, study is currently evaluating luvelta for patients with platinum-resistant ovarian cancer. A separate mid-stage study is also underway, evaluating luvelta in combination with bevacizumab for the same indication.
Apart from the NSCLC indication, Sutro Biopharma is also evaluating the candidate in additional ongoing studies to treat patients with endometrial cancer and leukemia. The company anticipates initiating the phase II/III REFRαME-P1 registration-directed study on luvelta for patients with CBF/GLIS2 acute myeloid leukemia (AML), a rare subtype of pediatric cancer, in the second half of 2024.