luveltamab tazevibulin (STRO-002) / Sutro Biopharma, Tasly, Blood Cancer United - LARVOL DELTA

Luveltamab tazevibulin (STRO-002), an anti-folate receptor alpha (FolRα) antibody drug conjugate (ADC), safety and efficacy in a broad distribution of FolRα expression in patients with recurrent epithelial ovarian cancer (OC): Update of STRO-002-GM1 phase 1 dose expansion cohort. (ASCO 2023) - P1 | "For pts with a TPS >25% (n=35), the median prior lines of therapy was 2.5 (range 1-3), 69% had prior bevacizumab treatment, and 83% prior PARP inhibitor treatment. These dose expansion data confirm activity of luvelta at starting doses ranging from 4.3-5.2 mg/kg in recurrent OC with FolRα expression as low as TPS>25% and supports further clinical study in this population. The global phase 2/3 REFRaME registration study will evaluate luvelta in PROC pts with TPS >25%. Clinical trial information: NCT03748186."

Clinical • P1 data • Anemia • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Musculoskeletal Pain • Neutropenia • Oncology • Ovarian Cancer • Septic Shock • Solid Tumor • FOLR1

Efficacy and safety of luveltamab tazevibulin in patients with recurrent platinum-resistant ovarian cancer: results from the dose-optimization stage of the REFRαME-O1 (GOG-3086, ENGOT-79OV, and APGOT-OV9) phase 2/3 study (SGO 2025) - No abstract available

Clinical • Late-breaking abstract • P2/3 data • Oncology • Ovarian Cancer • Solid Tumor

Luveltamab tazevibulin (STRO-002), an anti-folate receptor alpha (FolRα) antibody drug conjugate (ADC), demonstrates clinical activity in recurrent/progressive epithelial endometrial cancer (EEC): STRO-002-GM1 phase I dose expansion (ESMO 2023) - P1 | "Preliminary data indicate that luvelta has a predictable and manageable safety profile with encouraging clinical activity in pts with recurrent/progressive FolRα expressing EEC. Luvelta warrants further development as a targeted agent for EEC."

Clinical • IO biomarker • P1 data • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • PD-1

Nonprofit Acquires Abandoned Leukemia Drug Supply. (PubMed, Cancer Discov) - "The nonprofit organization Blood Cancer United acquired the remaining supply of luveltamab tazevibulin and will continue the compassionate use program for children with a rare form of AML. The move points to the challenges of funding pediatric cancer drug development."

Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics

STRO-002-GM2: A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer (clinicaltrials.gov) - P1 | N=58 | Recruiting | Sponsor: Sutro Biopharma, Inc. | Active, not recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer (clinicaltrials.gov) - P1; N=58; Recruiting; Sponsor: Sutro Biopharma, Inc.

Clinical • Combination therapy • New P1 trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • FOLR1

STRO-002-GM1: Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody Drug Conjugate in Ovarian & Endometrial Cancers (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Sutro Biopharma, Inc. | Trial primary completion date: Aug 2022 ➔ Aug 2024

Metastases • Trial primary completion date • Endometrial Adenocarcinoma • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Blood Cancer United Acquires Drug Supply to Preserve Access for Children With Rare Leukemia (Citybizlist) - "The Washington, D.C.-based nonprofit, formerly known as The Leukemia & Lymphoma Society, announced it has secured both the existing inventory of luveltamab tazevibulin and the rights necessary to provide the treatment through the FDA’s compassionate use pathway for children diagnosed with CBFA2T3-GLIS2-rearranged AML....Blood Cancer United stepped in to preserve access to the remaining drug supply at no cost to patients. The organization emphasized that it does not intend to commercialize the therapy and that its role is limited to maintaining availability while broader efforts continue to support research and regulatory pathways for rare pediatric cancers."

Commercial • Acute Myelogenous Leukemia

Anti-FRα antibody-drug conjugate luveltamab tazevibulin for the treatment of FRα-expressing non-small cell lung cancer (AACR 2025) - P2 | "Preliminary results from Phase 1 and 2/3 studies in endometrial and ovarian cancer, respectively, show robust clinical activity and enhanced tolerability of luvelta as a single agent and in combination with bevacizumab. Luvelta treatment in tumor-bearing mice also altered tumor immune cell infiltration and activation, demonstrating its ability to modulate the tumor immune microenvironment.In conclusion, the work presented here provides support for luvelta as a promising targeted therapy for NSCLC, either as monotherapy or in combination with immune checkpoint blockade. Luvelta is now being evaluated in a Phase 2 study in patients with advanced or metastatic NSCLC (NCT06555263)."

ADC • IO biomarker • Endometrial Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • CALR • EGFR • FOLR1 • HMGB1

TSL-B2276-1-01: A Study of STRO-002 in Chinese Adults With Epithelial Ovarian Cancer and Other Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=19 | Completed | Sponsor: Tasly Pharmaceutical Group Co., Ltd | Recruiting ➔ Completed | N=132 ➔ 19 | Trial completion date: Dec 2027 ➔ Dec 2025 | Trial primary completion date: Dec 2026 ➔ Jun 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Epithelial Ovarian Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PGR

HIGH INCIDENCE OF RELAPSE AFTER HAEMATOPOIETIC STEM CELL TRANSPLANTATION CONFERS A POOR PROGNOSIS IN PAEDIATRIC GLIS2+ AML- AN EBMT PAEDIATRIC DISEASES WORKING PARTY STUDY (EBMT 2026) - "Among patients in CR, MRD was negative in 19/22 (data missing for 12).All patients received myeloablative conditioning, predominantly Busulfan-based regimens (31/38, 81.6%)...Most children received ciclosporin (± MMF/MTX) as GVHD prophylaxis... In the largest cohort to date of children with GLIS2+ AML undergoing alloHSCT, outcomes are confirmed to be poor, with relapse being the predominant cause of treatment failure. This occurred despite most patients being in CR at transplantation and despite a high incidence of significant GVHD. These findings highlight an urgent need for targeted post-transplant therapies, such as the anti–folate receptor-α antibody–drug conjugate luveltamab tazevibulin (STRO-002) or CAR-T cells targeted against this target, in this high-risk group."

Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Developmental Disorders • Genetic Disorders • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Pediatrics • Transplantation • CBFA2T3 • FOLR1 • GLIS2

Positive outcomes associated with stem cell transplantation in pediatric/AYA patients who receive FLAG-IDA-venetoclax for high-risk AML (ASH 2025) - "Background : BCL-2 inhibitors like venetoclax have demonstrated encouraging remission rates whencombined with fludarabine, cytarabine, idarubicin, and G-CSF (FLAG-IDA), enabling more patients toproceed to stem cell transplantation (SCT)...All patients received a busulfan/fludarabine-basedconditioning regimen and received post-transplant cyclophosphamide and tacrolimus as GVHDprophylaxis...Two patients relapsed following HSCT at a median time of 203 days (196-209days), including the patient undergoing SCT with positive MRD and a patient with very high risk acutemegakaryoblastic leukemia who relapsed following cessation of a folate receptor 1-targeted antibodydrug conjugate (STRO-002) due to adverse effects...One patient experienced CMV reactivation 28 daysafter SCT with peak level of 338 IU/mL requiring IV foscarnet, 1 patient experienced MRSA bacteremia onday 10 following SCT treated with appropriate antibiotic coverage, and 1 patient experienceddisseminated..."

Clinical • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Hepatology • Immunology • Infectious Disease • Leukemia • Pediatrics • Transplantation • CD8 • FOLR1

Venetoclax and azacytidine in childhood primary advanced myelodysplastic syndromes, refractory/relapsed Acute Myeloid Leukemia and therapy-related myeloid diseases (ASH 2025) - "Two of these NR cases were rescued withrevumenib achieving CR...A cytofluorimetric CR was also reported in 2 DEK-NUP214 AML patientsand one CBFA2T3-GLIS2 AML patient who receives ven/aza with STRO002...Our cohort is the largest reportedto date in the difficult-to-treat subgroups of pediatric MDS-EB and t-MDS/AML, supporting futureprospective protocols using ven/aza. Further biological characterization of specific genetic subgroups,such as KMT2A-rearranged malignancies, may help refine the role of Bcl-2 inhibition and improve theprediction of treatment response."

Clinical • Metastases • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • CBFA2T3 • DEK • FLT3 • GLIS2 • KMT2A • NUP214

Anti-Leukemic Activity of Luveltamab Tazevibulin (LT, STRO-002), a Novel Folate Receptor-α (FR-α)-Targeting Antibody Drug Conjugate (ADC) in Relapsed/Refractory CBF2AT3::GLIS2 AML (ASH 2023) - "LT based therapy in CBF-GLIS AML provides clinical and laboratory responses that are highly unusual in this refractory patient population. LT has an acceptable safety profile and does not require inpatient delivery. Importantly, LT appears to be enabling these children to receive potential definitive therapy."

Acute Myelogenous Leukemia • Anemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Oncology • Pediatrics • Respiratory Diseases • CBFA2T3 • FOLR1 • GLIS2

REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1 (clinicaltrials.gov) - P2/3 | N=600 | Terminated | Sponsor: Sutro Biopharma, Inc. | Trial completion date: Feb 2028 ➔ Aug 2025 | Recruiting ➔ Terminated | Trial primary completion date: Aug 2027 ➔ Aug 2025; Due to strategic business considerations, Sutro has deprioritized the development of luveltamab tazevibulin, leading to termination of the REFRaME program. This decision is not related to any safety or efficacy concerns associated with luvelta

Platinum resistant • Trial completion date • Trial primary completion date • Trial termination • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • FOLR1

STRO-002-GM2: A Study of STRO-002, an Anti-Folate Receptor Alpha Antibody Drug Conjugate, in Combination With Bevacizumab in Epithelial Ovarian Cancer (clinicaltrials.gov) - P1 | N=58 | Terminated | Sponsor: Sutro Biopharma, Inc. | Trial completion date: Jan 2026 ➔ Jun 2025 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2025 ➔ Jun 2025; Terminated Early

Platinum resistant • Trial completion date • Trial primary completion date • Trial termination • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

REFRaME-L1: Study to Investigate Luveltamab Tazevibulin in Adults With Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Sutro Biopharma, Inc. | N=43 ➔ 0 | Trial completion date: Oct 2026 ➔ May 2025 | Recruiting ➔ Withdrawn | Trial primary completion date: Oct 2026 ➔ May 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML (clinicaltrials.gov) - P1/2 | N=24 | Terminated | Sponsor: Sutro Biopharma, Inc. | Trial completion date: Mar 2029 ➔ Jun 2025 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2028 ➔ Jun 2025; Terminated Early

Trial completion date • Trial primary completion date • Trial termination • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Long-term survival after luveltamab tazevibulin, a novel folate receptor-α (FRα) targeting antibody drug conjugate (ADC) in children with CBFA2T3::GLIS2 acute myeloid leukemia (AML). (ASCO 2025) - P1/2 | "Luvelta alone or in combination with AML chemotherapy could achieve MRD negativity in more than one third of CBF/GLIS2 AML patients, allowing transplant and resulting survival of more than 2 years. Additional children have received luvelta through compassionate use since 2023 and the pivotal phase 1/2 trial for these patients is now open and enrolling (clinicaltrials.gov NCT06679582)."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • CBFA2T3 • FOLR1 • GLIS2

A phase 1/2, open-label study evaluating the efficacy, safety, and pharmacokinetics of luveltamab tazevibulin in infants and children < 12 years of age with CBFA2T3::GLIS2 acute myeloid leukemia. (ASCO 2025) - P1/2 | "Patients without CR after 2 cycles of luvelta monotherapy may add chemotherapy (cytarabine +/- fludarabine or azacytidine) in cycle 3 and beyond...Secondary endpoints include PK levels and assessment of anti-drug antibody formation, safety, EFS and overall survival. Rates of measurable residual disease-negative CR and FRα antigen levels pre- and post-luvelta will also be explored."

Clinical • P1/2 data • PK/PD data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • CBFA2T3 • FOLR1 • GLIS2

The anti-FRα antibody-drug conjugate luveltamab tazevibulin demonstrates efficacy in non-small cell lung cancer preclinical models and induces immunogenic cell death. (PubMed, Mol Cancer Ther) - P1, P2/3 | "This improved activity with combination therapy was associated with increased tumoral infiltration of CD8+ T cells. In conclusion, the work presented here provides rationale for evaluating luveltamab tazevibulin in NSCLC either as monotherapy or in combination with immune checkpoint blockade."

Journal • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CALR • CD8 • FOLR1 • HMGB1

Sutro Biopharma Presents Data from Dose-Optimization Portion of REFRαME-O1 Trial in Patients with Platinum Resistant Ovarian Cancer at SGO 2025 (GlobeNewswire) - P2/3 | N=600 | REFRαME-O1 (NCT05870748) | Sponsor: Sutro Biopharma, Inc. | "Late-Breaking Oral Presentation Highlights: At the selected optimized dose (5.2 mg/kg), luvelta achieved an ORR of 32%1 and a disease control rate (DCR) of 96% compared to an ORR of 13.8% and a DCR of 69% for the 4.3 mg/kg group. The demonstrated clinical activity in the 5.2 mg/kg group was consistent in patients across all levels of FRα expression of 25% or greater, with an ORR of 30.8% and a DCR of 100% for positive staining (PS) 2+ ≥75% (eligible for approved FRα-targeting ADC) and an ORR of 33.3%1 and DCR of 91.7%1 for PS2+ < 75%. Safety was consistent across dosing groups, with no new safety signals observed and neutropenia well-managed. The majority of patients across both dose cohorts received prior bevacizumab....The Company recently announced that it is deprioritizing investment into the development of luvelta across all indications."

Commercial • Late-breaking abstract • P2/3 data • Ovarian Cancer

Showcasing Phase II & III Readouts of Luvelta & Outlining Predications for Future ADC Innovation (ADC London 2025) - "Synopsis • Sharing an update on clinical data for Luvelta targeting FRα in recurrent, platinum-resistant ovarian cancer, endometrial cancer, and AML • Reflecting on the development and main drivers of successes in the ADC field • Exploring future directions of the ADC field across dual payload conjugates, including Immune activating payload ADCs"

P2 data • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

The Efficacy And Safety Of Folate Receptor a-Targeted Antibody-Drug Conjugate Therapy In Patients With High-Grade Epithelial Ovarian, Primary Peritoneal, Or Fallopian Tube Cancers: A Systematic Review And Meta-Analysis (ESGO 2025) - "The protocol was registered with PROSPERO (CRD42023491151).Results Ten studies with a total of 940 patients (859 treated with mirvetuximab soravtansine-gynx (MIRV), 45 with farletuzumab ecteribulin (MORAb-202), and 36 with luveltamab tazevibulin (STRO-002)) were included in this meta-analysis. The incidence of grade ≥3 adverse events was 27% (95% CI: 0.19–0.36).Conclusion FRα-targeting ADCs, including MIRV, demonstrated definite efficacy and good safety as novel choices for second-line and beyond treatment of advanced or recurrent ovarian cancer. Patients with high FRα expression showed ORR and PFS benefits similar to those in the overall cohort."

Retrospective data • Review • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Folate Receptor Alpha (FRa) Prevalence In Platinum Resistant Ovarian Cancer From Phase 1 Studies Of The Novel Antibody Drug Conjugate, Luveltamab Tazevibulin (ESGO 2025) - P1, P2/3 | "It shows promise as both monotherapy and combination therapy with bevacizumab in women with platinum resistant ovarian cancer (PROC), including those with FRα-low to medium tumors. Conclusion Luvelta has the potential to become best-in-class FRα-tubulin-ADC and change the treatment landscape for ~8 of 10 women with FRα-positive PROC, including those with low to medium FRα expression. Luvelta is currently being evaluated in a pivotal phase 2/3 study in PROC patients with FRα ≥25% TPS (REFRαME-O1, STRO-002-GM3 [NCT05870748, ENGOT-OV79, GOG-3086, GEICO-134-O, APGOT-OV9])."

P1 data • Oncology • Ovarian Cancer • Solid Tumor • FOLR1