Sutro Biopharma Announces Updated Data from Phase 1b Study of Luvelta in Combination with Bevacizumab at ESMO 2024
Sutro Biopharma (NASDAQ: STRO) announced updated data from its Phase 1b study of luveltamab tazevibulin (luvelta) in combination with bevacizumab for epithelial ovarian cancer (EOC) at ESMO 2024. Key findings include:
- 56% objective response rate at the recommended phase 2 dose (RP2D) of 4.3 mg/kg luvelta with 15 mg/kg bevacizumab
- 35% overall response rate across all dose ranges
- Efficacy observed regardless of Folate Receptor-α (FRα) expression
- No new safety signals compared to individual agents
- Expansion phase ongoing with 23 additional patients; data expected in H1 2025
The combination shows promise as a non-biomarker driven approach for EOC treatment, potentially benefiting a broader patient population.
Sutro Biopharma (NASDAQ: STRO) ha annunciato dati aggiornati dal suo studio di Fase 1b di luveltamab tazevibulin (luvelta) in combinazione con bevacizumab per il cancro ovarico epiteliale (EOC) all'ESMO 2024. I risultati chiave includono:
- 56% di tasso di risposta obiettiva alla dose raccomandata di Fase 2 (RP2D) di 4,3 mg/kg di luvelta con 15 mg/kg di bevacizumab
- 35% di tasso di risposta complessivo in tutti i range di dosaggio
- Efficacia osservata indipendentemente dall'espressione del recettore della folato-α (FRα)
- Nessun nuovo segnale di sicurezza rispetto agli agenti singoli
- Fase di espansione in corso con 23 pazienti aggiuntivi; dati attesi nel primo semestre del 2025
La combinazione mostra potenzialità come approccio non basato su biomarcatori per il trattamento dell'EOC, potenzialmente a beneficio di una popolazione di pazienti più ampia.
Sutro Biopharma (NASDAQ: STRO) anunció datos actualizados de su estudio de Fase 1b de luveltamab tazevibulin (luvelta) en combinación con bevacizumab para el cáncer de ovario epitelial (EOC) en el ESMO 2024. Los hallazgos clave incluyen:
- 56% de tasa de respuesta objetiva a la dosis recomendada de fase 2 (RP2D) de 4,3 mg/kg de luvelta con 15 mg/kg de bevacizumab
- 35% de tasa de respuesta general en todos los rangos de dosis
- Eficacia observada independientemente de la expresión del receptor de folato-α (FRα)
- Sin nuevas señales de seguridad en comparación con los agentes individuales
- Fase de expansión en curso con 23 pacientes adicionales; se esperan datos para el primer semestre de 2025
La combinación muestra promesa como un enfoque no basado en biomarcadores para el tratamiento del EOC, lo que podría beneficiar a una población de pacientes más amplia.
Sutro Biopharma (NASDAQ: STRO)는 ESMO 2024에서 luveltamab tazevibulin (luvelta)와 베바시주맙을 병용한 상피 난소암 (EOC)에 대한 1b상 연구의 업데이트된 데이터를 발표했습니다. 주요 발견 사항은 다음과 같습니다:
- 4.3 mg/kg luvelta와 15 mg/kg bevacizumab의 권장 2상 용량 (RP2D)에서 56%의 객관적 반응률
- 모든 용량 범위에서 35%의 전체 반응률
- Folate Receptor-α (FRα) 발현 여부와 관계없이 관찰된 효능
- 개별 약제에 비해 새로운 안전 신호 없음
- 추가 23명의 환자를 포함한 확장 단계 진행 중; 2025년 상반기 데이터 예정
이 조합은 EOC 치료를 위한 바이오마커에 의존하지 않는 접근 방식으로 잠재력을 보여주며, 더 넓은 환자 집단에게 혜택을 줄 수 있습니다.
Sutro Biopharma (NASDAQ: STRO) a annoncé des données mises à jour de son étude de Phase 1b sur luveltamab tazevibulin (luvelta) en combinaison avec le bevacizumab pour le cancer de l'ovaire épithélial (EOC) lors de l'ESMO 2024. Les principales conclusions comprennent :
- 56% de taux de réponse objective à la dose recommandée de phase 2 (RP2D) de 4,3 mg/kg de luvelta avec 15 mg/kg de bevacizumab
- 35% de taux de réponse global dans toutes les plages de doses
- Efficacité observée indépendamment de l'expression du récepteur de folate-α (FRα)
- Aucun nouveau signal de sécurité par rapport aux agents individuels
- Phase d'expansion en cours avec 23 patients supplémentaires ; des données à attendre au premier semestre 2025
La combinaison montre un potentiel prometteur en tant qu'approche non basée sur des biomarqueurs pour le traitement de l'EOC, ce qui pourrait bénéficier à une population de patients plus large.
Sutro Biopharma (NASDAQ: STRO) hat aktualisierte Daten aus seiner Phase 1b-Studie zu luveltamab tazevibulin (luvelta) in Kombination mit Bevacizumab für epithelialen Eierstockkrebs (EOC) auf dem ESMO 2024 vorgestellt. Zu den wichtigsten Ergebnissen gehören:
- 56% objektive Ansprechrate bei der empfohlenen Phase 2-Dosis (RP2D) von 4,3 mg/kg luvelta mit 15 mg/kg Bevacizumab
- 35% Gesamtansprechrate über alle Dosisbereiche hinweg
- Wirksamkeit unabhängig von der Folat-Rezeptor-α (FRα) Expression beobachtet
- Keine neuen Sicherheitsmeldungen im Vergleich zu den einzelnen Wirkstoffen
- Erweiterungsphase läuft mit 23 zusätzlichen Patienten; Daten werden im ersten Halbjahr 2025 erwartet
Die Kombination zeigt vielversprechendes Potenzial als nicht-biomarkerbasierter Ansatz für die Behandlung von EOC, was möglicherweise einer breiteren Patientengruppe zugutekommen könnte.
- 56% objective response rate at the recommended phase 2 dose (RP2D)
- 35% overall response rate across all dose ranges
- Efficacy observed regardless of Folate Receptor-α (FRα) expression
- Median duration of response of 9.3 months
- No new safety signals compared to individual agents
- Potential for non-biomarker driven approach to treat EOC patients
- Only 18 patients enrolled in the initial study, limiting statistical power
- One patient discontinued treatment, potentially due to adverse effects or lack of efficacy
Insights
This data from Sutro Biopharma's Phase 1b study of luvelta with bevacizumab is promising for ovarian cancer treatment. The 56% objective response rate at the recommended phase 2 dose is particularly encouraging, especially considering it's effective regardless of FRα expression. This could potentially broaden the patient population that can benefit from this therapy.
The 35% overall response rate across all dose ranges is also noteworthy, suggesting robust efficacy. The median duration of response of 9.3 months indicates lasting benefits for responders. Importantly, the safety profile aligns with previous findings, with neutropenia as the main side effect, which is manageable in clinical settings.
The potential for a non-biomarker driven approach is significant, as it could simplify patient selection and expand treatment options. However, we'll need to see the expanded cohort data in 2025 to confirm these promising early results.
Sutro Biopharma's latest clinical data could significantly impact its market position. The positive results from the luvelta and bevacizumab combination study may enhance the company's valuation, especially if the expanded cohort data in 2025 confirms these findings.
Investors should note the potential for a broader market if the therapy proves effective regardless of FRα expression. This could translate to higher revenue potential and market share in the competitive ovarian cancer treatment landscape.
However, it's important to consider that full commercialization is still years away, pending successful completion of later-stage trials and regulatory approvals. The company's cash runway and ability to fund ongoing research will be critical factors to watch. While these results are promising, they represent an early-stage milestone in a long and costly drug development process.
- 4.3 mg/kg of luveltamab tazevibulin (luvelta) in combination with standard dose of bevacizumab (15 mg/kg) every 3 weeks resulted in a
- Luvelta in combination with bevacizumab demonstrated encouraging preliminary antitumor activity (
- Expansion at RP2D is ongoing with an additional 23 patients enrolled to date; expansion data are expected in the first half of 2025 -
- No new safety signals were observed compared with either agent alone -
SOUTH SAN FRANCISCO, Calif., Sept. 14, 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 updated data from the ongoing Phase 1b study of luveltamab tazevibulin (luvelta) in combination with bevacizumab for patients with epithelial ovarian cancer (EOC) in a poster presentation at the 2024 European Society For Medical Oncology (ESMO) Congress in Barcelona, Spain.
In this study, luvelta plus bevacizumab has demonstrated encouraging antitumor activity in patients with late-stage ovarian cancer irrespective of Folate Receptor-α (FRα) expression, including patients with no FRα expression, and prior bevacizumab treatment, with an overall response rate of
“We are encouraged by these results achieved with luvelta in combination with bevacizumab, which may offer the opportunity to benefit ovarian cancer patients regardless of FRα expression,” said Jane Chung, Sutro’s President and Chief Operating Officer. “We have already seen promising antitumor activity with luvelta as a monotherapy treatment and we believe these combination data support our goal to deliver effective therapies to more patients living with cancer. We look forward to sharing initial results from our expansion phase in the first half of 2025.”
ESMO Poster Presentation Highlights:
- 18 patients were enrolled; one patient remains on treatment.
- Luvelta plus bevacizumab demonstrated encouraging antitumor activity in 17 RECIST evaluable patients:
- At the RP2D (4.3 mg/kg), an Objective Response Rate (ORR) of
56% (5/9) was observed; no (0/6) patients had a response at 3.5 mg/kg and50% (1/2) of patients had a response at 5.2 mg/kg. - An ORR of
35% (6/17) was observed in the overall population with a median duration of response of 9.3 months. - In patients with ≥
25% FRα expression, an ORR of44% (4/9) was observed; in patients with <25% FRα expression, an ORR of29% (2/7) was observed.
- At the RP2D (4.3 mg/kg), an Objective Response Rate (ORR) of
- No new safety signals were observed compared with either agent alone; consistent with previous reported luvelta safety results, the most common adverse event was neutropenia.
The Presentation will be accessible through the News & Events page of the Investor Relations section of the company’s website at www.sutrobio.com.
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 additional ongoing trials in patients with endometrial cancer, non-small cell lung cancer, and in combination with bevacizumab in patients with ovarian cancer. 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, in the second half of 2024. 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, 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; potential benefits of luvelta and the Company’s other product candidates and platform; potential market opportunities for luvelta and the Company’s other product candidates; and the Company’s expected cash runway. 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, the value of the Company’s holdings of Vaxcyte common stock, 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.
Contact
Emily White
Sutro Biopharma
(650) 823-7681
ewhite@sutrobio.com
FAQ
What is the recommended phase 2 dose (RP2D) for luvelta in combination with bevacizumab?
What was the objective response rate for STRO's luvelta at the RP2D in the Phase 1b study?
When does Sutro Biopharma (STRO) expect to share initial results from the expansion phase of the luvelta study?
How did luvelta perform in patients with low Folate Receptor-α (FRα) expression in the STRO study?
