Leap Therapeutics Announces Completion of Enrollment in Part B of the DeFianCe Study of DKN-01 for the Treatment of Colorectal Cancer Patients
Leap Therapeutics has completed enrollment of 188 patients in Part B of the DeFianCe study, evaluating DKN-01 for second-line treatment of advanced colorectal cancer (CRC). The study combines DKN-01, an anti-Dickkopf-1 antibody, with standard bevacizumab and chemotherapy. Dr. Cynthia Sirard, Chief Medical Officer, highlighted the enthusiasm for DKN-01's potential, citing encouraging data from Part A showing clinically meaningful response rates and durable tumor reductions.
The Phase 2, open-label, global study's primary endpoint is progression-free survival (PFS), with an additional focus on PFS in left-sided CRC patients. Secondary objectives include objective response rate, duration of response, and overall survival. Initial data from Part B is expected in mid 2025.
Leap Therapeutics ha completato l'arruolamento di 188 pazienti nella Parte B dello studio DeFianCe, che valuta DKN-01 per il trattamento di seconda linea del cancro colorettale avanzato (CRC). Lo studio combina DKN-01, un anticorpo anti-Dickkopf-1, con bevacizumab standard e chemioterapia. La Dott.ssa Cynthia Sirard, Chief Medical Officer, ha evidenziato l'entusiasmo per il potenziale di DKN-01, citando dati incoraggianti dalla Parte A che mostrano tassi di risposta clinicamente significativi e riduzioni tumorali durevoli.
Il principale obiettivo primario dello studio di Fase 2, aperto e globale, è la survival senza progressione (PFS), con un'ulteriore attenzione sulla PFS nei pazienti con CRC di sinistra. Gli obiettivi secondari includono il tasso di risposta obiettivo, la durata della risposta e la sopravvivenza complessiva. I dati iniziali della Parte B sono attesi per metà 2025.
Leap Therapeutics ha completado la inscripción de 188 pacientes en la Parte B del estudio DeFianCe, que evalúa DKN-01 para el tratamiento de segunda línea del cáncer colorrectal avanzado (CRC). El estudio combina DKN-01, un anticuerpo anti-Dickkopf-1, con bevacizumab estándar y quimioterapia. La Dra. Cynthia Sirard, Directora Médica, destacó el entusiasmo por el potencial de DKN-01, citando datos alentadores de la Parte A que muestran tasas de respuesta clínicamente significativas y reducciones tumorales duraderas.
El objetivo primario de este estudio de Fase 2, abierto y global, es la supervivencia libre de progresión (PFS), con un enfoque adicional en la PFS en pacientes con CRC del lado izquierdo. Los objetivos secundarios incluyen la tasa de respuesta objetiva, la duración de la respuesta y la supervivencia general. Se esperan datos iniciales de la Parte B para mediados de 2025.
Leap Therapeutics는 188명의 환자 등록을 완료했습니다 DeFianCe 연구의 B 파트에서, DKN-01의 2차 치료법인 진행성 대장암 (CRC)을 평가합니다. 이 연구는 DKN-01(항-Dickkopf-1 항체), 표준 베바시주맙 및 화학요법을 결합합니다. Cynthia Sirard 박사(의료 책임자)는 DKN-01의 잠재력에 대한 열정을 강조하며, 임상적으로 의미 있는 반응률과 지속적인 종양 감소를 보여주는 A 파트의 고무적인 데이터를 인용했습니다.
이 개방 라벨 글로벌 2상 연구의 주요 임상적 목표는 무진행 생존율 (PFS)로, 좌측 CRC 환자에서의 PFS도 추가적으로 주목합니다. 이차적 목표에는 객관적 반응률, 반응 지속 기간, 전체 생존이 포함됩니다. 초기 데이터는 B파트에서 2025년 중반에 예상됩니다.
Leap Therapeutics a terminé le recrutement de 188 patients dans la partie B de l'étude DeFianCe, évaluant DKN-01 pour le traitement de deuxième ligne du cancer colorectal avancé (CRC). L'étude combine DKN-01, un anticorps anti-Dickkopf-1, avec le bevacizumab standard et la chimiothérapie. Le Dr. Cynthia Sirard, Directrice Médicale, a souligné l'enthousiasme pour le potentiel de DKN-01, en citant des données encourageantes de la partie A montrant des taux de réponse cliniquement significatifs et des réductions tumorales durables.
Le principal objectif de cette étude de phase 2, ouverte et mondiale, est la survie sans progression (PFS), avec un accent supplémentaire sur la PFS chez les patients atteints de CRC à gauche. Les objectifs secondaires incluent le taux de réponse objectif, la durée de la réponse et la survie globale. Des données initiales de la partie B sont attendues pour mi-2025.
Leap Therapeutics hat die Einschreibung von 188 Patienten in Teil B der DeFianCe-Studie abgeschlossen, die DKN-01 als zweite Behandlungsoption bei fortgeschrittenem kolorektalem Krebs (CRC) bewertet. Die Studie kombiniert DKN-01, einen Anti-Dickkopf-1-Antikörper, mit dem Standardbehandlungsmittel Bevacizumab und Chemotherapie. Dr. Cynthia Sirard, Chief Medical Officer, hob die Begeisterung für das Potenzial von DKN-01 hervor und verwies auf ermutigende Daten aus Teil A, die klinisch bedeutsame Ansprechquoten und haltbare Tumorverkleinerungen zeigen.
Der primäre Endpunkt der offenen, globalen Phase-2-Studie ist die progressionsfreie Überlebensrate (PFS), wobei zusätzlich der Fokus auf der PFS bei Patienten mit linksseitigem CRC liegt. Zu den sekundären Zielen gehören die objektive Ansprechrate, die Dauer der Reaktion und das Gesamtüberleben. Erste Daten aus Teil B werden für mitte 2025 erwartet.
- Completed enrollment of 188 patients in Part B of the DeFianCe study
- Encouraging data from Part A showed clinically meaningful response rates and durable tumor reductions
- Expanded study from 130 to 188 patients, indicating increased interest and potential
- Initial data from Part B not expected until mid 2025, indicating a long wait for results
Insights
The completion of enrollment in Part B of the DeFianCe study is a significant milestone for Leap Therapeutics' DKN-01 development program in colorectal cancer (CRC). This phase 2 trial evaluates DKN-01 in combination with standard therapies as a second-line treatment, which addresses a critical need in advanced CRC management.
Key points to consider:
- The study expanded from 130 to 188 patients, indicating strong interest and potentially faster data generation.
- Primary endpoint of progression-free survival (PFS) is clinically relevant and aligns with regulatory expectations.
- Additional focus on left-sided CRC subpopulation may reveal targeted efficacy, potentially leading to a more defined patient population for future trials.
- Initial data expected in mid-2025 will be important for assessing DKN-01's potential and informing future development decisions.
While promising, investors should note that phase 2 results are still exploratory and success here would likely lead to a larger, more definitive phase 3 trial before potential approval. The timeline suggests no immediate revenue impact, but positive data could significantly influence Leap's valuation and partnership prospects.
This news, while promising for Leap Therapeutics' clinical progress, has immediate financial impact. Key financial considerations include:
- No direct revenue generation from this development, as DKN-01 is still in clinical trials.
- Potential increase in R&D expenses due to the expanded trial size (from 130 to 188 patients).
- Cash burn rate may accelerate, which is important for a small-cap biotech (
$102.9M market cap) without marketed products. - Positive data in 2025 could lead to partnership opportunities or increased investor interest, potentially improving Leap's financial position.
- The focus on colorectal cancer, a large market, presents significant long-term revenue potential if DKN-01 proves successful.
Investors should monitor Leap's cash position and burn rate in upcoming quarterly reports. While the expanded trial and potential positive data in 2025 could be value-driving events, the company may need additional financing before reaching key milestones. The stock remains speculative, with its value largely tied to the success of DKN-01 in this and other trials.
"The completion of enrollment in Part B of the DeFianCe study marks a significant achievement and highlights the enthusiasm in the potential of DKN-01 from both patients and healthcare providers," said Cynthia Sirard, M.D., Chief Medical Officer of Leap. "The encouraging data from Part A of the study which showed clinically meaningful response rates and durable tumor reductions, as well as a favorable safety profile in advanced CRC patients, provides a strong foundation to the expanded Part B of the study. We look forward to sharing initial data from Part B, including the subpopulation of patients with left-sided CRC, in mid 2025."
The DeFianCe study (NCT05480306) is a Phase 2, open-label, global study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy for advanced disease. Part B of the study expanded from a 130 to a 188-patient randomized controlled trial, with the primary endpoint being progression free survival (PFS). An additional primary endpoint will measure PFS in the subpopulation of patients with left-sided CRC. Secondary objectives include objective response rate, duration of response, and overall survival.
About Leap Therapeutics
Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (
FORWARD-LOOKING STATEMENTS
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CONTACT:
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President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
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Investor Relations
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FAQ
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