Launch of the REFR?ME-L1 Phase 2 Trial
Sutro Biopharma, Inc. (Sutro) (NASDAQ: STRO), a company focused on oncology research, has announced the launch of the REFR?ME-L1 trial. This global Phase 2 study will assess the effects of luveltamab tazevibulin (luvelta) in patients with non-small cell lung cancer (NSCLC) whose tumors express Folate Receptor-? (FR?). Enrollment for the study is currently open, with initial results expected in the first half of 2025.
Significance of the REFR?ME-L1 Study
The REFR?ME-L1 trial represents a crucial step in Sutro’s mission to expand the use of luvelta. Dr. Anne Borgman, Sutro’s Chief Medical Officer, highlighted the trial's importance, stating, “The initiation of REFR?ME-L1 is a key milestone in our efforts to broaden the application of luvelta for a diverse group of patients with FR? expressing cancers.” Preclinical studies have indicated that luvelta could be a significant new treatment option for NSCLC, especially due to its targeted design and capability to treat patients with lower FR? expression levels.
An Overview of Lung Cancer
Lung cancer continues to be the leading cause of cancer-related deaths worldwide. Most patients are diagnosed only after the cancer has spread, contributing to a dismal five-year survival rate of around 8%. While there are various treatment options, many patients with advanced NSCLC eventually develop resistance to these therapies, which limits their treatment choices as the disease progresses.
Folate Receptor-? in Lung Cancer
FR? is found in several types of cancer, including NSCLC, but its presence in normal tissues is quite limited. Studies show that about 30% of patients with adenocarcinoma NSCLC demonstrate FR? expression, making it a promising target for advanced NSCLC therapies. This highlights the potential for targeted treatments to enhance outcomes for these patients.
Structure of the REFR?ME-L1 Trial
The REFR?ME-L1 trial is designed to assess the safety and efficacy of luvelta in adults with previously treated advanced or metastatic NSCLC whose tumors express FR? at a Tumor Proportion Score (TPS) of 25% or higher. Participants will receive doses of 4.3 mg/kg of luvelta every three weeks throughout the duration of the trial.
Luveltamab Tazevibulin: A New Treatment Alternative
Luveltamab tazevibulin, or “luvelta,” is an innovative FR?-targeting antibody-drug conjugate specifically created to treat a broad spectrum of patients with ovarian cancer, including those with lower FR? expression levels who may not qualify for existing FR?-targeted therapies. The drug has been developed using Sutro’s advanced cell-free XpressCF platform, resulting in a consistent ADC that delivers four hemiasterlin cytotoxins per antibody directly to the tumor site.
Clinical Pipeline and Future Research
Sutro Biopharma is actively expanding its clinical research initiatives. The ongoing REFR?ME-O1 trial, a Phase 2/3 study, targets patients with platinum-resistant ovarian cancer. Furthermore, Sutro is conducting trials for patients with endometrial cancer and non-small cell lung cancer, and plans to initiate REFR?ME-P1, a Phase 2/3 registration-directed study for acute myeloid leukemia in pediatric patients.
Regulatory Approvals and Market Opportunities
The U.S. Food and Drug Administration (FDA) has granted luvelta Fast Track designation for ovarian cancer, along with Orphan and Rare Pediatric Disease designations for its indication in acute myeloid leukemia. These recognitions emphasize the potential therapeutic advantages of luvelta and provide pathways for faster development and approval.
About Sutro Biopharma
Sutro Biopharma, Inc. is dedicated to the innovation and development of precisely designed therapeutics for cancer treatment. By leveraging its cutting-edge technology, including the proprietary XpressCF platform, Sutro strives to improve patient treatment experiences and expand access to effective therapies. The company’s promising pipeline of clinical-stage candidates, particularly luvelta, underscores its commitment to advancing targeted cancer therapies. Sutro operates from its headquarters in South San Francisco and maintains an active 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 designed to evaluate the safety and efficacy of luveltamab tazevibulin in patients with non-small cell lung cancer that expresses Folate Receptor-?.
What is luveltamab tazevibulin?
Luveltamab tazevibulin, commonly known as luvelta, is an antibody-drug conjugate created to treat patients with cancers that express FR?.
Who qualifies for the REFR?ME-L1 trial?
Patients who have previously received treatment for advanced or metastatic NSCLC with FR? expression of 25% or greater Tumor Proportion Score are eligible for the trial.
What is the dosing schedule for luvelta in the trial?
Participants in the trial will receive doses of 4.3 mg/kg of luvelta every three weeks.
What designations has luvelta received from health authorities?
The FDA has awarded luvelta Fast Track designation for ovarian cancer and Orphan and Rare Pediatric Disease designations for acute myeloid leukemia.
