Luveltamab tazevibulin is an antibody drug conjugate that was developed to target folate receptor alpha (FRα). FRα is found on the cell surface of some cancer cells but it is not found on the surface of normal cells and this makes FRα an attractive target for cancer drug development. Luvelta is designed to work on tumors that had FRα expression in at least 25% of cancer cells. We have made the difficult decision to deprioritize the development of luvelta following a strategic portfolio review resulting in the prioritization of its Next-Generation ADC Pipeline. We are seeking a global partner to fully realize the potential of luvelta. During this time, we will not be inititing new sites. Patients currently in our trials will continue and we will be working with our investigators in the best interest of our patients.
Phase 2 trial evaluating the safety and efficacy of luvelta in adult patients with previously treated advanced or metastatic NSCLC with FRα expression ≥25% Tumor Proportion Score (TPS). We have determined that a protocol amendment will be needed to conform the dose to align with the dose finding results in our REFRαME–O1 ovarian cancer study, presented in December. At the current time this study is not enrolling.
REFRαME-O1 is a study of luvelta in platinum resistant ovarian cancer that overexpresses FRα. While we seek a global partner to fully realize the potential for luvelta,we are not opening additionl sites and are continuint to treat the patients in our studies, with the best interest of our patients at the center of these decisions.
The study is enrolling patients in the sites which are currently active. Sutro may also continue to provide luveltamab tazevibulin through Compassionate Use Access. Sutro previously provided luveltamab tazevibulin through Compassionate Use Access, with initial results from 25 children presented at the 2023 American Society of Hematology meeting (https://ash.confex.com/ash/2023/webprogram/Paper180141.html). While these results are promising, the treatment is experimental.
WHO IS SUTRO?
Sutro Biopharma, Inc., is relentlessly focused on the discovery and development of precisely designed cancer therapeutics to transform 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 is advancing a robust early-stage pipeline of novel exatecan and dual-payload antibody drug conjugates (ADCs), coupled with high-value collaborations and industry partnerships, which validate its continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com.