Sutro Biopharma Announces Selected Dose for Luvelta and Topline Results from Dose-Optimization Portion of REFRαME-O1 Trial in Platinum Resistant Ovarian Cancer
Sutro Biopharma announced positive results from the dose-optimization portion of the REFRαME-O1 trial for luvelta in platinum-resistant ovarian cancer. The selected 5.2 mg/kg starting dose achieved a 32% objective response rate in evaluable patients, with a disease control rate of 96%. The trial included patients with ≥25% FRα expression levels, potentially benefiting 8 out of 10 PROC patients.
The study demonstrated manageable safety profiles with 32% of patients experiencing Grade 3 or higher neutropenia, but no febrile neutropenia. The ongoing registrational trial (Part 2) will enroll approximately 500 patients, randomized between luvelta and standard chemotherapy. The company is targeting an Accelerated Approval application in mid-2027.
Sutro Biopharma ha annunciato risultati positivi dalla fase di ottimizzazione della dose dello studio REFRαME-O1 per luvelta nel trattamento del cancro ovarico resistente al platino. La dose iniziale selezionata di 5,2 mg/kg ha raggiunto un tasso di risposta obiettivo del 32% nei pazienti valutabili, con un tasso di controllo della malattia del 96%. Lo studio ha incluso pazienti con livelli di espressione di FRα ≥25%, beneficiando potenzialmente 8 pazienti su 10 con cancro ovarico resistenti al platino.
Lo studio ha dimostrato profili di sicurezza gestibili, con il 32% dei pazienti che ha sperimentato neutropenia di Grado 3 o superiore, senza però casi di neutropenia febbrile. Il trial registrativo in corso (Parte 2) prevede l'arruolamento di circa 500 pazienti, randomizzati tra luvelta e chemioterapia standard. L'azienda punta a una domanda di approvazione accelerata a metà del 2027.
Sutro Biopharma anunció resultados positivos de la fase de optimización de dosis del ensayo REFRαME-O1 para luvelta en cáncer de ovario resistente a platino. La dosis inicial seleccionada de 5.2 mg/kg logró una tasa de respuesta objetiva del 32% en pacientes evaluables, con una tasa de control de la enfermedad del 96%. El ensayo incluyó pacientes con niveles de expresión de FRα ≥25%, beneficiando potencialmente a 8 de cada 10 pacientes con cáncer de ovario resistente a platino.
El estudio demostró perfiles de seguridad manejables, con el 32% de los pacientes experimentando neutropenia de Grado 3 o superior, sin neutropenia febril. El ensayo registral en curso (Parte 2) inscribirá aproximadamente 500 pacientes, aleatorizados entre luvelta y quimioterapia estándar. La empresa tiene como objetivo presentar una solicitud de Aprobación Acelerada a mediados de 2027.
수트로 생명공학(Sutro Biopharma)는 플래티넘 내성 난소암에 대한 루벨타(luvelta)의 REFRαME-O1 시험의 용량 최적화 부분에서 긍정적인 결과를 발표했습니다. 선택된 초기 용량인 5.2 mg/kg은 평가 가능한 환자에서 32%의 객관적 반응률을 달성했으며, 질병 조절률은 96%였습니다. 이 시험은 FRα 발현 수준이 ≥25%인 환자를 포함했으며, 이는 플래티넘 내성 난소암 환자의 10명 중 8명이 혜택을 볼 수 있습니다.
연구는 32%의 환자가 3도 이상의 호중구감소증을 경험했지만, 열성 호중구감소증은 없었으며 관리 가능한 안전성 프로필을 나타냈습니다. 현재 진행 중인 등록 시험(2부)은 약 500명의 환자를 등록하여 루벨타와 표준 화학요법 간에 무작위 배정할 예정입니다. 회사는 2027년 중반에 가속 승인 신청을 목표로 하고 있습니다.
Sutro Biopharma a annoncé des résultats positifs de la phase d'optimisation de la dose de l'essai REFRαME-O1 pour luvelta dans le cancer de l'ovaire résistant au platine. La dose de départ sélectionnée de 5,2 mg/kg a atteint un taux de réponse objective de 32% chez les patients évaluables, avec un taux de contrôle de la maladie de 96%. L'essai a inclus des patients présentant des niveaux d'expression de FRα ≥25%, pouvant potentiellement bénéficier à 8 patients sur 10 atteints de cancer de l'ovaire résistant au platine.
L'étude a démontré des profils de sécurité gérables, avec 32% des patients présentant une neutropénie de grade 3 ou supérieur, mais sans neutropénie fébrile. L'essai d'enregistrement en cours (Partie 2) recrutera environ 500 patients, répartis aléatoirement entre luvelta et la chimiothérapie standard. L'entreprise vise une demande d'approbation accélérée à la mi-2027.
Sutro Biopharma gab positive Ergebnisse aus der Dosis-Optimierungsphase der REFRαME-O1-Studie für luvelta bei platinsensiblem Ovarialkarzinom bekannt. Die ausgewählte Anfangsdosis von 5,2 mg/kg erzielte eine objektive Ansprechrate von 32% bei evaluierbaren Patienten, mit einer Krankheitskontrollrate von 96%. Die Studie umfasste Patienten mit einer FRα-Expressionsrate von ≥25%, was potenziell 8 von 10 Patienten mit platinsensiblem Ovarialkarzinom zugutekommen könnte.
Die Studie zeigte ein beherrschbares Sicherheitsprofil, wobei 32% der Patienten eine Neutropenie von Grad 3 oder höher erfuhren, jedoch keine febrile Neutropenie auftrat. Die laufende Registrierungstudie (Teil 2) wird voraussichtlich rund 500 Patienten rekrutieren, die randomisiert zwischen luvelta und der Standardchemotherapie aufgeteilt werden. Das Unternehmen plant einen Antrag auf beschleunigte Zulassung Mitte 2027.
- 32% objective response rate in evaluable patients
- 96% disease control rate
- Potential to treat 8 out of 10 PROC patients
- Well-managed safety profile with no febrile neutropenia
- Positioned for Accelerated Approval pathway
- 32% of patients experienced Grade 3 or higher neutropenia
- Accelerated Approval timeline extends to mid-2027
Insights
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- 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 -
SOUTH SAN FRANCISCO, Calif., Dec. 10, 2024 (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 the selected dose from the dose-optimization portion (Part 1) of REFRαME-O1, the registration-directed trial of luveltamab tazevibulin (luvelta) in platinum-resistant ovarian cancer (PROC), following a meeting with the U.S. Food and Drug Administration (FDA).
"The topline results confirm luvelta’s favorable safety and efficacy profile at the starting dose of 5.2 mg/kg, further supporting our confidence that it can improve clinical outcomes compared to chemotherapy in our ongoing registrational trial," said Anne Borgman, M.D., Sutro’s Chief Medical Officer. “Consistent response rates were observed in patients across all levels of FRα expression of
REFRαME-O1 (Part 1)
REFRαME-O1 (Part 1) evaluated luvelta in patients with PROC with low, medium, and high FRα expression levels. This includes patients with ≥
Topline Results from Evaluable Patients (5.2 mg/kg group; N = 25):
- Achieved an objective response rate (ORR) of
32% , which includes one partial response that confirmed post data extraction1 - Disease control rate of
96% - Approximately half of the patients treated were ineligible for an approved FRα-targeting ADC
88% of patients received prior bevacizumab- Grade 3 or higher neutropenia occurred in
32% of patients, no febrile neutropenia
“The clinical results from Part 1 of REFRαME-O1 provide compelling evidence that luvelta has the potential to be both first in class and best in class for patients who have low to medium expression of FRα. FRα is a validated target, and luvelta has the opportunity to reach more patients in need,” commented Bradley Monk, M.D., Florida Cancer Specialists and Research Institute; Director GOG Partners.
“The topline safety profile of luvelta from Part 1 is encouraging. Neutropenia rates were low, highlighting successful management guidelines. Furthermore, the lack of serious ocular damage, pancytopenia, or Interstitial Lung Disease provide further confidence in our ability to treat a broad group of women with PROC with a focus on their overall wellbeing,” stated Wendel Naumann, M.D., Professor, Levine Cancer, Atrium Health/Wake Forest University, Charlotte, NC.
REFRαME-O1 (Part 2) Registrational Trial
REFRαME-O1 (Part 2) is an ongoing global registrational trial for patients with PROC, evaluating a 5.2 mg/kg dose with prophylactic pegfilgrastim (G-CSF) for the first two cycles followed by a 4.3 mg/kg dose for subsequent cycles. Part 2 will enroll approximately 500 patients, randomized 1:1 to luvelta or investigators’ choice of chemotherapy. Luvelta is positioned for an Accelerated Approval application in mid-2027.
*1: Data as of Aug 16, 2024.
About Luveltamab Tazevibulin
Luveltamab tazevibulin, abbreviated as “luvelta” and formerly known as STRO-002, is a FRα-targeting antibody-drug conjugate (ADC) designed to treat a broad range of patients with ovarian cancer, including those with lower FRα-expression who are not eligible for approved treatment options targeting FRα. 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. REFRαME-O1, a Phase 2/3 registration-directed study for patients with platinum-resistant ovarian cancer is ongoing. The Company has another ongoing registration-directed trial, REFRαME-P1, for patients with CBF/GLIS acute myeloid leukemia, a rare subtype of pediatric cancer, as well as additional ongoing trials in patients with endometrial cancer, non-small cell lung cancer, and in combination with bevacizumab in patients with ovarian cancer. 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/GLIS 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, 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 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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities, including enrollment and site activation; timing of announcements of clinical results, trial initiation, and regulatory filings; outcome of discussions with regulatory authorities; potential benefits of luvelta and the Company’s other product candidates and platform; potential business development and partnering transactions; and potential market opportunities for luvelta and the Company’s other product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates and the Company’s ability to successfully leverage Fast Track designation, the market size for the Company’s product candidates to be smaller than anticipated, clinical trial sites, supply chain and manufacturing facilities, the Company’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the Company’s ability to protect intellectual property, and the Company’s commercial collaborations with third parties and other risks and uncertainties described under the heading “Risk Factors” in documents the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
FAQ
What was the objective response rate for luvelta in the REFRαME-O1 trial (STRO)?
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