Sutro Biopharma Highlights Potential Multi-Cancer Opportunity for Luvelta, a FolRα-targeting ADC
Fast TrackASCOClinical ResultADC
Ovarian cancer data supports registration-enabling trial of luvelta for women with platinum-resistant ovarian cancer
Potential benefit to 8 out of 10 platinum-resistant ovarian cancer patients, including addressing unmet need in patients with low-medium FolRα expression
Promising clinical activity and tolerability of luvelta as both a monotherapy and in combination across multiple cancers may provide for a significant commercial opportunity
Jan. 04, 2024 -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), is hosting an investor webcast today highlighting the significant potential of luveltamab tazevibulin (luvelta), a novel folate receptor-α (FolRα) targeting ADC. The presentation will include an overview of the clinical data supporting luvelta’s broad opportunity to address the unmet need in several FolRα-expressing cancers, including platinum-resistant ovarian cancer (PROC), endometrial cancer, CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) acute myeloid leukemia (AML), and non-small cell lung cancer (NSCLC).
“Luvelta has been studied in over 180 patients to-date, and has demonstrated both promising clinical activity and a tolerable safety profile. We are optimistic about its potential to change the cancer treatment landscape,” said Bill Newell, Sutro’s Chief Executive Officer. “This includes the potential to be the first ADC to treat ovarian cancer patients with low to medium FolRα expression, which could double the current eligible patient population relative to the FolRα-targeting ADC on the market. In 2024, we look forward to advancing two synergistic registrational clinical trials for luvelta in ovarian cancer and CBF/GLIS AML, while continuing to progress the development of additional indications.”
The event will feature presentations by key members of Sutro's senior management team and external oncology expert, Bradley Monk, M.D., Professor, the Division of Gynecologic Oncology, University of Arizona College of Medicine and Creighton University School of Medicine and Vice President and Co-Director, GOG Partners. Sutro management and Dr. Monk will participate in a Q&A session at the end of the presentation.
Luvelta FolRα-targeting ADC Franchise Upcoming Milestones:
The registration-directed trial, REFRαME-O1, in PROC is enrolling, with 26 active sites across 5 countries and an anticipated ~140 sites in ~20 countries by the end of 2024. Part 1 of the trial is expected to be completed in the first half of 2024.
Initiation of REFRαME-P1, a registration-enabling trial for pediatric patients with CBF/GLIS AML, is planned for the first half of 2024.
An Investigational New Drug (IND) application submission is planned in non-small cell lung cancer (NSCLC) in the first half of 2024.
Continued clinical development is planned in endometrial cancer and in combination with bevacizumab for the treatment of ovarian cancer.
Compelling Luvelta Data:
Sutro presented an aggregated analysis of nearly 100 women with ovarian cancer from Company’s Phase 1 program.
Treatment with luvelta demonstrated improved clinical outcomes and tolerability compared to historical results with standard of care chemotherapy in an evaluable patient population matching the eligibility criteria for the REFRαME-O1 trial.
The safety profile across the aggregated analysis remained consistent with previously reported data.
Safety data from an additional cohort with prophylactic G-CSF treatment showed significant reduction of neutropenia and resulting dose delays.
New data in combination with bevacizumab demonstrated clinical activity in treated patients regardless of FolRα expression level.
Promising clinical data in late-stage endometrial cancer and CBF/GLIS AML have been presented at ESMO and ASH in 2023.
About Luveltamab Tazevibulin
Luveltamab tazevibulin, abbreviated as “luvelta” and formerly known as STRO-002, is a FolRα-targeting antibody-drug conjugate (ADC) designed to treat a broad range of patients with ovarian cancer, including those with lower FolRα-expression who are not eligible for approved treatment options targeting FolRα. Developed and manufactured with Sutro’s cell-free XpressCF® platform, luvelta is a homogeneous ADC with four hemiasterlin cytotoxins per antibody, precisely positioned to efficiently deliver to the tumor while ensuring systemic stability after dosing. Sutro recently initiated REFRαME-O1, a Phase 2/3 registration-directed study for patients with platinum-resistant ovarian cancer. The Company has ongoing trials in patients with endometrial cancer and in combination with bevacizumab in patients with ovarian cancer. In the first half of 2024, the Company expects to initiate REFRαME-P1, a Phase 2/3 registration-directed study for patients with CBF/GLIS2 acute myeloid leukemia, a rare subtype of pediatric cancer, and expects to file an Investigational New Drug (IND) Application for the initiation of a non-small cell lung cancer study. The U.S. Food and Drug Administration (FDA) has granted luvelta a Fast Track designation for Ovarian Cancer, as well as Orphan and Rare Pediatric Disease designations for CBF/GLIS2 Pediatric AML.
About Sutro Biopharma
Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience. Sutro has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates Sutro’s continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com.
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