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

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) - "The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • 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 | "Clinical Trial Registration Number: NCT06679582 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • P1/2 data • PK/PD data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CBFA2T3 • 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 • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • 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

Sutro Biopharma Reports Second Quarter 2024 Financial Results, Business Highlights and Select Anticipated Milestones (GlobeNewswire) - "Recent Business Highlights and Select Anticipated Milestones - Luveltamab Tazevibulin (luvelta), FRα-Targeting ADC Franchise: (i) Sutro will present updated data from the Phase 1b study of luvelta in combination with bevacizumab for patients with ovarian cancer in a poster presentation at the...ESMO Congress 2024...; (ii) REFRαME-P1, a registration-enabling trial for pediatric patients with CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) AML, is expected to be initiated in the second half of 2024; (iii) A Phase 2 expansion study in combination with bevacizumab is ongoing, with data expected in the first half of 2025; (iv) A Phase 2 trial for the treatment of NSCLC is expected to initiate in the second half of 2024, with initial data expected in the first half of 2025."

New P2 trial • New trial • P1 data • P2 data • Acute Myelogenous Leukemia • Non Small Cell Lung Cancer • Ovarian Cancer

EFFICACY AND SAFETY OF LUVELTAMAB TAZEVIBULIN IN PATIENTS WITH RECURRENT PLATINUM-RESISTANT OVARIAN CANCER: THE REFRAME-01 (GOG-3086, ENGOT-79OV, AND APGOT-OV9) PHASE 2/3 STUDY (IGCS 2024) - P2/3 | " Randomized, open-label, phase 2/3 study evaluating the efficacy and safety of luvelta vs investigator's choice chemotherapy (ICC; gemcitabine, paclitaxel, pegylated liposomal doxorubicin, or topotecan) in patients with recurrent PROC expressing FRα (NCT05870748). Current Trial Status: Part 1 is closed and part 2 has recently opened enrolment, planning to recruit approx. 550 patients."

Clinical • P2/3 data • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • PROC

Luveltamab tazevibulin, an antifolate receptor alpha (FRα) antibody-drug conjugate (ADC), in combination with bevacizumab (bev) in patients with recurrent high-grade epithelial ovarian cancer (EOC): STRO-002-GM2 phase I study (ESMO 2024) - P1 | "Encouraging antitumor activity was observed irrespective of FRa expression and prior bev treatment. This combination may offer a non-biomarker driven approach. Luvelta + bev had no new safety signals vs either alone."

Clinical • Combination therapy • P1 data • Oncology • Ovarian Cancer • Solid Tumor • FOLR1

Sutro Biopharma Announces Updated Data from Phase 1b Study of Luvelta in Combination with Bevacizumab at ESMO 2024 (GlobeNewswire) - P1 | N=58 | NCT05200364 | Sponsor: Sutro Biopharma, Inc. | "The expansion phase of the study is ongoing at the recommended phase 2 dose (RP2D) of luvelta (4.3 mg/kg) in combination with bevacizumab (15 mg/kg) with an additional 23 patients enrolled to date; initial data is expected in the first half of 2025...Luvelta plus bevacizumab demonstrated encouraging antitumor activity in 17 RECIST evaluable patients: At the RP2D (4.3 mg/kg), an Objective Response Rate (ORR) of 56% (5/9) was observed; no (0/6) patients had a response at 3.5 mg/kg and 50% (1/2) of patients had a response at 5.2 mg/kg. An ORR of 35% (6/17) was observed in the overall population with a median duration of response of 9.3 months. In patients with ≥25% FRα expression, an ORR of 44% (4/9) was observed; in patients with <25% FRα expression, an ORR of 29% (2/7) was observed. No new safety signals were observed compared with either agent alone..."

P1 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

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 | Recruiting | Sponsor: Sutro Biopharma, Inc. | Trial completion date: Feb 2026 ➔ Feb 2028 | Trial primary completion date: Sep 2025 ➔ Aug 2027

Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • FOLR1

Study to Investigate Luveltamab Tazevibulin in Adults With Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=43 | Recruiting | Sponsor: Sutro Biopharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Sutro Biopharma Announces Initiation of REFRαME-L1 Phase 2 Trial with Luvelta for Patients with Non-Small Cell Lung Cancer (GlobeNewswire) - "Sutro Biopharma, Inc...today announced that REFRαME-L1, the global Phase 2 study of luveltamab tazevibulin (luvelta) for patients with non-small cell lung cancer (NSCLC) whose tumor expresses Folate Receptor-α (FRα), has been initiated and is open for enrollment. Initial data from this study is expected in the first half of 2025....Patients are expected to be dosed with 4.3 mg/kg of luvelta every three weeks."

P2 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology