Sutro Biopharma has announced the commencement of the international Phase II REFRαME-L1 clinical trial of luveltamab tazevibulin (luvelta) to treat patients with non-small cell lung cancer (NSCLC).
The trial, which is now open for enrolment, will assess the safety and efficacy of luvelta in NSCLC patients who exhibit Folate Receptor-α (FRα) expression.
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Initial data from the trial are anticipated in the first half of next year.
FRα is said to be prevalent in various cancer types, including NSCLC, but is minimally expressed in normal tissues. This makes it a potential therapeutic target for advanced NSCLC treatments, offering patients a chance for targeted therapy.
The trial will specifically assess luvelta in adult patients with advanced or metastatic NSCLC who have previously undergone treatment and have a Tumour Proportion Score (TPS) of FRα expression ≥25%.
Trial subjects will receive a dose of 4.3mg/kg of luvelta every three weeks.
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By GlobalDataAn antibody-drug conjugate (ADC) targeting FRα, it is created to cater to a wide patient demographic, including those with ovarian cancer who have lower FRα expression levels and are not eligible for existing FRα-targeted therapies.
Luvelta is developed using Sutro’s cell-free XpressCF platform, resulting in a homogeneous ADC with four hemiasterlin cytotoxins attached to each antibody.
This precise configuration is intended to deliver the drug efficiently to tumours while maintaining stability in the system post-dosing.
A Phase II/III REFRαME-O1 study is ongoing in patients with platinum-resistant ovarian cancer.
Sutro Biopharma is also conducting additional trials for patients with endometrial cancer, NSCLC, and in combination with bevacizumab for ovarian cancer patients.
Moreover, the company plans to initiate the REFRαME-P1 Phase II/III study for patients with CBF/GLIS2 acute myeloid leukaemia in the second half of this year.
Luvelta received fast track designation for ovarian cancer, as well as orphan and rare paediatric disease designations for CBF/GLIS2 paediatric AML from the US Food and Drug Administration (FDA) previously.
Sutro Biopharma chief medical officer Anne Borgman said: “The initiation of REFRαME-L1 is an important milestone in our efforts to expand the application of luvelta to a broad range of patients with FRα expressing cancers.”
Last year, the company announced plans to submit investigational new drug (IND) applications for two ADCs, STRO-003 and STRO-004, in Q1 2024 and Q1 2025, respectively.
