US-based biotechnology company Sutro Biopharma has begun the REFRαME-P1 trial of Luvelta (luveltamab tazevibulin) to treat paediatric patients with a type of acute myeloid leukaemia (AML).
The registration-enabling study will enrol infants and children aged younger than 12 years with CBFA2T3::GLIS2 (CBF/GLIS) AML.
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The trial aims to assess Luvelta’s efficacy and safety, with most of its sites due to open by the end of the year.
Sutro Biopharma chief medical officer Anne Borgman said: “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 leukaemia.
“We look forward to bringing this promising targeted therapy to a paediatric patient group with limited effective treatment options.”
Previously known as STRO-002, Luvelta is a folate receptor alpha (FRα) targeting antibody-drug conjugate (ADC) developed using Sutro’s cell-free platform, XpressCF.
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By GlobalDataIn December last year, data from the compassionate use of Luvelta in 25 paediatric patients with relapsed/refractory CBF/GLIS AML demonstrated complete remission in 42% of patients with ≥5% blasts.
The results also showed sustained overall survival, allowing some patients to undergo haematopoietic stem cell transplants.
In addition to REFRαME-P1, Sutro Biopharma is trialling Luvelta in people with endometrial cancer and non-small cell lung cancer, as well as in combination with bevacizumab in ovarian cancer patients.
The US Food and Drug Administration (FDA) has given the drug fast-track designation for ovarian cancer treatment, as well as orphan and rare paediatric disease designations for CBF/GLIS paediatric AML.
Based in California, Sutro Biopharma aims to improve cancer care by developing treatments for areas of unmet need.
The company’s portfolio includes ADCs, bispecific antibodies, cytokine-based immuno-oncology therapies and vaccines.
Last year, it announced plans to submit investigational new drug applications for two ADC candidates, STRO-003 and STRO-004.
