On June 3, 2023 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported 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) (Free ASCO Whitepaper) (ASCO 2023) Annual Meeting in Chicago, IL (Press release, Sutro Biopharma, JUN 3, 2023, View Source [SID1234632429]). 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.

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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 were seen in FolRα expressing patients with TPS >25%, addressing patients who may not be eligible for other approved therapies targeting FolRα.

"I am encouraged by the preliminary efficacy, durability, and favorable safety profile observed in this study, which signify the potential of luveltamab tazevibulin as a promising therapeutic option for patients with ovarian cancer who are not well supported by current standard of care," commented Dr. Oaknin. "The population of ovarian cancer patients that may benefit from treatment with luveltamab tazevibulin represents a significant unmet medical need globally."

"We are excited to share these promising data in an oral presentation at ASCO (Free ASCO Whitepaper), a globally respected oncology conference, which demonstrate the meaningful clinical benefit that luvelta may offer to ovarian cancer patients across a broad range of heterogeneity in FolRα-expression," said Anne Borgman, M.D., Sutro’s Chief Medical Officer. "On the heels of these positive results, we are thrilled that REFRaME, our pivotal Phase 2/3 trial, is officially underway. From the clinical and nonclinical data gathered, we maintain our positive outlook that luvelta could potentially serve multiple additional indications where patients express FolRα."

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 REFRaME, 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. The company is also assessing the clinical path forward for CBF/GLIS2 acute myeloid leukemia, a rare subtype of pediatric cancer, as well as non-small cell lung cancer.