Sutro Biopharma Launches Phase 2 Trial for Lung Cancer Therapy
Initiation of the REFR?ME-L1 Phase 2 Trial
Sutro Biopharma, Inc. (Sutro) (NASDAQ: STRO), a clinical-stage oncology company, has announced the initiation of the REFR?ME-L1 trial. This global Phase 2 study will evaluate the effects of luveltamab tazevibulin (luvelta) for patients suffering from non-small cell lung cancer (NSCLC) who have tumors expressing Folate Receptor-? (FR?). The study is now open for enrollment, and initial data is anticipated in the first half of 2025.
Importance of the REFR?ME-L1 Study
The REFR?ME-L1 study marks a significant milestone in Sutro’s quest to broaden the therapeutic applications of luvelta. Dr. Anne Borgman, Sutro’s Chief Medical Officer, commented on the importance of this trial, stating, “The initiation of REFR?ME-L1 is an important milestone in our efforts to expand the application of luvelta to a broad range of patients with FR? expressing cancers.” Preclinical research has shown that luvelta could represent an important new treatment option for NSCLC, particularly due to its precise design and the ability to treat patients with a lower FR? expression profile.
Lung Cancer: An Overview
Lung cancer remains the leading cause of cancer-related mortality globally. A majority of patients receive a diagnosis only after the disease has metastasized, contributing to a notably low five-year survival rate of approximately 8%. Although there are numerous treatment strategies available, many patients with advanced NSCLC gradually develop resistance to these therapies, leading to limited treatment options as their disease progresses.
Folate Receptor-? in Lung Cancer
FR? is observed in several cancer types, including NSCLC, yet its expression in normal tissues is relatively limited. Research reveals that roughly 30% of patients with adenocarcinoma NSCLC exhibit FR? expression, positioning FR? as a promising therapeutic target for advanced NSCLC. This signifies the potential for targeted therapies to improve treatment outcomes for these patients.
The Design of the REFR?ME-L1 Trial
The REFR?ME-L1 trial aims to evaluate both the safety and effectiveness of luvelta in adults with previously treated advanced or metastatic NSCLC whose tumors express FR? at a level of 25% or higher Tumor Proportion Score (TPS). Participants will receive dosing of 4.3 mg/kg of luvelta every three weeks throughout the trial.
Luveltamab Tazevibulin: An Innovative Treatment Option
Luveltamab tazevibulin, also referred to as “luvelta,” is a novel FR?-targeting antibody-drug conjugate specifically designed to address a wide range of patients with ovarian cancer, including those who exhibit lower levels of FR? expression and are not eligible for existing FR?-targeted therapies. The drug has been developed using Sutro’s advanced cell-free XpressCF platform, resulting in a homogeneous ADC that effectively delivers four hemiasterlin cytotoxins per antibody to the tumor site.
Clinical Pipeline and Future Studies
Sutro Biopharma continues to expand its clinical research portfolio. The ongoing REFR?ME-O1 trial, a Phase 2/3 study, focuses on patients with platinum-resistant ovarian cancer. Additionally, Sutro is actively conducting trials in patients with endometrial cancer and non-small cell lung cancer, and has plans to start REFR?ME-P1, a Phase 2/3 registration-directed study for acute myeloid leukemia in pediatric patients.
Regulatory Designations and Market Potential
The U.S. Food and Drug Administration (FDA) has already awarded luvelta with Fast Track designation for ovarian cancer, alongside Orphan and Rare Pediatric Disease designations for its acute myeloid leukemia indication. These designations underscore the potential therapeutic benefit of luvelta and provide pathways for accelerated development and approval.
About Sutro Biopharma
Sutro Biopharma, Inc. is a company focused on the innovation and development of precisely designed therapeutics for the treatment of cancer. By utilizing its cutting-edge technology, including the proprietary XpressCF platform, Sutro aims to enhance the patient treatment experience and broaden patient access to effective therapies. The company's promising pipeline of clinical-stage candidates, notably luvelta, reinforces its commitment to advancing targeted cancer therapies. Sutro operates from its headquarters in South San Francisco and maintains an ongoing presence on social media platforms.
Frequently Asked Questions
What is the REFR?ME-L1 trial?
The REFR?ME-L1 trial is a Phase 2 study aimed at evaluating the safety and efficacy of luveltamab tazevibulin in patients with non-small cell lung cancer expressing Folate Receptor-?.
What is luveltamab tazevibulin?
Luveltamab tazevibulin, abbreviated as luvelta, is an antibody-drug conjugate designed to treat patients with cancers expressing FR?.
Who is eligible for the REFR?ME-L1 trial?
Patients with previously treated advanced or metastatic NSCLC with FR? expression of 25% or greater Tumor Proportion Score are eligible for the trial.
What are the dosing schedules for luvelta in the trial?
Patients participating in the trial will receive doses of 4.3 mg/kg of luvelta every three weeks.
What recognition has luvelta received from health authorities?
The FDA has granted luvelta Fast Track designation for ovarian cancer and Orphan and Rare Pediatric Disease designations for acute myeloid leukemia.
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