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

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

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)."

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

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

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

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

Sutro Biopharma and Boehringer Ingelheim BioXcellence collaboration: Established first-in-class cell-free capabilities at commercial scale (GlobeNewswire) - "Boehringer Ingelheim BioXcellence and Sutro Biopharma Inc. today announced that they successfully applied Sutro’s proprietary cell-free expression technology on a commercial scale to manufacture luveltamab tazevibulin (luvelta), Sutro’s Tubulin FRα-targeting antibody-drug conjugate (ADC) designed to treat a broad range of patients with ovarian cancer and other FRα expressing cancers...For the first time, the cross-functional teams were able to scale up Sutro’s cell-free protein synthesis platform from a small-scale Good Manufacturing Practice (GMP) production to a large-scale GMP production marking an industry milestone. All batches of luvelta manufactured in 4,500 L at Boehringer’s large-scale manufacturing facility in Vienna, Austria, met the product quality criteria required for the use in clinical studies....These insights can be applied to their robust pipeline of next-generation ADCs targeting a variety of cancers."

Commercial • Ovarian Cancer

Sutro Biopharma Announces Selected Dose for Luvelta and Topline Results from Dose-Optimization Portion of REFRαME-O1 Trial in Platinum Resistant Ovarian Cancer (GlobeNewswire) - P2/3 | N=600 | REFRaME-O1 (NCT05870748) | Sponsor: Sutro Biopharma, Inc. | "32% objective response rate (ORR) in evaluable patients at the 5.2 mg/kg starting dose – the selected dose for randomized portion (Part 2) of ongoing registrational REFRαME-O1 trial; These data confirm luvelta’s robust response rate in patients with late-stage ovarian cancer expressing a broad range of folate receptor alpha (FRα); Neutropenia well-managed; no new safety findings; Luvelta is positioned for an Accelerated Approval application in mid-2027."

FDA filing • P2/3 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

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

The Efficacy and Safety of Folate Receptor α-Targeted Antibody-Drug Conjugate Therapy in Patients With High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers: A Systematic Review and Meta-Analysis. (PubMed, Cancer Med) - "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."

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

Sutro Biopharma Reports Third Quarter 2024 Financial Results and Business Highlights (GlobeNewswire) - "Recent Business Highlights and Select Anticipated Milestones - Luveltamab Tazevibulin (luvelta), FRα-Targeting ADC Franchise:...(i) An expansion study of...the Phase 1b study of luvelta in combination with bevacizumab for patients with ovarian cancer...is ongoing, with data expected in the first half of 2025; (ii) A Phase 2 trial for the treatment of NSCLC is underway, with initial data expected in 2025."

P1 data • P2 data • Non Small Cell Lung Cancer • Ovarian Cancer

Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age with Relapsed/Refractory CBFA2T3::GLIS2 AML (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Sutro Biopharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age with Relapsed/Refractory CBFA2T3::GLIS2 AML (clinicaltrials.gov) - P1/2 | N=24 | Not yet recruiting | Sponsor: Sutro Biopharma, Inc.

New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Sutro Biopharma Demonstrates Meaningful ADC Innovation with Five Presentations at the 15th Annual World ADC Conference (GlobeNewswire) - "Presentation Details:...Showcasing Clinical Update & Learnings for Luvelta Targeting Folate Receptor....Characterizing ADC Safety & Activity in Preclinical Development of STRO-004...."

Clinical data • Preclinical • Oncology

Sutro Biopharma Announces Initiation of the Registration-enabling REFRαME-P1 Trial with Luvelta for Pediatric Patients with CBF/GLIS AML (GlobeNewswire) - "Sutro Biopharma, Inc...announced that REFRαME-P1, the registration-directed study of luveltamab tazevibulin (luvelta) for pediatric patients with CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) acute myeloid leukemia (AML), has been initiated and is open for enrollment."

Trial status • Acute Myelogenous Leukemia