Business
Sutro Biopharma Announces Oral Presentation at ASCO 2023 Featuring Data for Luveltamab Tazevibulin from the Phase 1 Dose-Expansion Study in Ovarian Cancer and the Initiation of the Phase 2/3 Pivotal Study REFRaME-O1
- Consistent with data shared in January 2023, the presentation at ASCO 2023 highlights data from the Phase 1 dose-expansion study for luveltamab tazevibulin,
About this update from Sutro Biopharma, Inc.
[{"type":"text","content":"- Consistent with data shared in January 2023, the presentation at ASCO 2023 highlights data from the Phase 1 dose-expansion study for luveltamab tazevibulin, or luvelta, in ovarian cancer, demonstrating that FolRα-selected patients, who represent 80% of the patient population, experienced substantial clinical benefit - - REFRaME-O1, the Phase 2/3 pivotal study of luvelta for patients with platinum-resistant ovarian cancer has been initiated and is open for enrollment - SOUTH SAN FRANCISCO, Calif., June 03, 2023 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that results from a Phase 1 dose-expansion study of luveltamab tazevibulin (luvelta), a novel Folate receptor alpha (FolRα)-targeting ADC, in patients with advanced ovarian cancer were featured in an oral presentation at the 2023 American Society of Clinical Oncology (ASCO 2023) Annual Meeting in Chicago, IL. In parallel, the Company continues to advance the clinical development of luvelta and announced that sites are now open for enrollment in REFRaME-O1, the pivotal Phase 2/3 study for patients with platinum-resistant ovarian cancer. Data from the Phase 1 dose-expansion study of luvelta were presented by co-Principal Investigator, Ana Oaknin, M.D., Ph.D., Head of the Gynecological Tumor Unit and Attending Physician at the Vall d’Hebron University Hospital in Barcelona and Principal Clinical Investigator of the Gynecological Malignancies Group at the Vall d’Hebron Institute of Oncology. Consistent with data reported in January 2023, luvelta demonstrated substantial clinical benefit in FolRα-selected patients, defined by Tumor Proportion Score (TPS) of >25%, irrespective of staining intensity, which represents approximately 80% of the advanced ovarian cancer patient population. When focusing on patients with a FolRα expression level above 25% (Tumor Proportion Score, or TPS >25% and regardless of staining intensity), the efficacy outcomes exhibited a 37.5% ORR, a median DOR of 5.5 months, and a median PFS of 6.1 months. Notably, at the higher starting dose level of 5.2 mg/kg, these patients experienced even higher response rates, with a 43.8% ORR, a median DOR of 5.4 months, and a median PFS of 6.6 months. Responses we...