Sutro Biopharma has announced the initiation of the REFRαME-P1 trial, a pivotal study designed to evaluate the efficacy and safety of Luvelta (luveltamab tazevibulin) in pediatric patients with CBFA2T3::GLIS2 acute myeloid leukemia (AML). This registration-enabling trial focuses on infants and children under 12 years of age, representing a significant step forward in addressing a rare and aggressive form of leukemia with limited treatment options.
Luvelta: A Targeted Approach to Pediatric AML
Luvelta, previously known as STRO-002, is an antibody-drug conjugate (ADC) that targets folate receptor alpha (FRα). Developed using Sutro's XpressCF cell-free platform, Luvelta is designed to selectively deliver a cytotoxic payload to AML cells expressing FRα, potentially minimizing off-target effects and improving patient outcomes.
Anne Borgman, chief medical officer of Sutro Biopharma, stated, “We are excited to announce the initiation of our second pivotal trial, the registration-enabling clinical trial of Luvelta in infants and toddlers with a rare and aggressive form of leukemia. We look forward to bringing this promising targeted therapy to a pediatric patient group with limited effective treatment options.”
Promising Compassionate Use Data
Data from the compassionate use of Luvelta in 25 pediatric patients with relapsed/refractory CBF/GLIS AML demonstrated encouraging results. The data showed complete remission in 42% of patients with ≥5% blasts. Furthermore, the results indicated sustained overall survival, enabling some patients to proceed with potentially curative haematopoietic stem cell transplants.
Ongoing Clinical Development and Regulatory Designations
In addition to the REFRαME-P1 trial, Sutro Biopharma is investigating Luvelta in other cancer types, including endometrial cancer, non-small cell lung cancer, and ovarian cancer (in combination with bevacizumab). The US Food and Drug Administration (FDA) has granted Luvelta fast-track designation for ovarian cancer treatment, as well as orphan and rare pediatric disease designations for CBF/GLIS pediatric AML, underscoring the urgent need for effective therapies in these patient populations.
Sutro Biopharma's Broader Oncology Pipeline
Sutro Biopharma, based in California, is focused on developing novel cancer therapies to address unmet medical needs. The company's portfolio includes ADCs, bispecific antibodies, cytokine-based immuno-oncology therapies, and vaccines. Sutro announced plans last year to submit investigational new drug applications for two additional ADC candidates, STRO-003 and STRO-004, further expanding its oncology pipeline.
