Presentation Event Entity Entity Process Occurrent Occurrent 2025-05-07T10:19:50 RDF description of [presentation] - http://repository.healthpartners.com/individual/document-rn38474 α): the REFRaME-L1 phase 2 study public 23749 Clinical Trials document-rn38474 presentation Lung Cancer <p>Background: The treatment of recurrent or metastatic NSCLC remains a challenge, particularly in pts with relapsed disease following standard-of-care anti-PD(L)1 immune checkpoint inhibitor and platinum-doublet chemotherapy. FR � 25% cutoff represents an estimated 25% of pts. In a panel of NSCLC PDX models with FR α expression, administration of luvelta led to significant inhibition of tumor growth in 78% of FRα -positive models and either a partial response or complete response in 44%. These results collectively support investigation of luvelta in pts with advanced, previously treated NSCLC expressing FRα. <br>Methods: This global, open-label, phase 2 study (REFRaME-L1) has been designed to assess the efficacy and safety of luvelta in adults with previously treated advanced or metastatic NSCLC expressing FRα. Eligible pts are adults ( � 18 years) with previously treated, advanced NSCLC of AC or ASQ histology, who have received 2�4 prior lines of therapy, have measurable disease per RECIST v1.1, ECOG performance status � 1, and TPS for FR α expression � 25%. Pts with tumors harboring actionable genomic alterations are allowed, following treatment with approved targeted therapies. FR α is a cell-surface glycoprotein found in multiple cancers, including ovarian and NSCLC. It is an attractive therapeutic target for NSCLC of the adenocarcinoma (AC) subtype, as it is highly expressed in cancer cells but has limited expression in normal tissue. Luveltamab tazevibulin (luvelta) is an anti α expression will be determined centrally using the investigational use only Ventana FOLR1 (FOLR1-2.1) RxDx assay (Roche Diagnostics). Enrollment of � 43 pts is planned. Pts will receive intravenous luvelta every 3 weeks Primary endpoint is ORR, with response evaluated by investigator, per RECIST v1.1. Secondary endpoints include PFS, DOR, safety, and PK. The study is open and enrolling globally at the time of the submission (ClinicalTrials.gov NCT06555263). –FR α-targeting antibody-drug conjugate with a stable cleavable linker and a 3-aminophenyl hemiasterlin warhead (DAR=4), which induces cytotoxic and immunologic cell death. Luvelta was designed to treat multiple cancers with a broad range of FRα expression. In a phase 1 study of luvelta in relapsed ovarian cancer, selected for FRα expression level of � 25% at any intensity (tumor proportion score [TPS]), the overall response rate (ORR) was 37.5% with a median duration of response (DOR) of 5.5 months, and a median progression-free survival (PFS) of 6.1 months. ORR was higher at 5.2 mg/kg compared with 4.3 mg/kg (43.8% vs 31.3%). The safety profile among 44 pts was manageable, with the most common grade � 3 adverse events consisting of neutropenia, arthralgia, and anemia (Oaknin et al. J Clin Oncol 2023;41[16 suppl]:5508). In AC and adenosquamous carcinoma (ASQ) NSCLC, the FR α TPS <p> Chemotherapy 41118 Drugs and Drug Therapy [presentation] Efficacy and safety of luveltamab tazevibulin in patients (pts) with advanced, previously treated non-small cell lung cancer (NSCLC) expressing folate receptor alpha (FR 2025-01-31T22:52:05.028-06:00 ASCO (American Society of Clinical Oncology) 2025 Annual Meeting