Merck Announces Phase 3 waveLINE-010 Trial Initiation Evaluating Zilovertamab Vedotin, an Investigational Antibody-Drug Conjugate, for the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
Merck (MRK) has initiated waveLINE-010, a pivotal Phase 3 clinical trial evaluating zilovertamab vedotin in combination with R-CHP compared to R-CHOP alone for previously untreated diffuse large B-cell lymphoma (DLBCL) patients. The trial, which has begun global recruitment, will enroll approximately 1,046 patients.
Zilovertamab vedotin is Merck's investigational antibody-drug conjugate targeting ROR1. The study's primary endpoint is progression-free survival, with secondary endpoints including complete response rate, overall survival, event-free survival, duration of complete response, and safety.
The initiation follows encouraging results from the Phase 2 waveLINE-007 trial. The drug is also being evaluated in the Phase 2/3 waveLINE-003 trial for relapsed or refractory DLBCL. Initial data was presented at the 66th American Society of Hematology Annual Meeting in December 2024.
Merck (MRK) ha avviato il trial clinico fondamentale waveLINE-010, un trial di Fase 3 che valuta zilovertamab vedotin in combinazione con R-CHP rispetto a R-CHOP da solo per pazienti affetti da linfoma diffuso a grandi cellule B (DLBCL) mai trattati in precedenza. Il trial, che ha iniziato la reclutamento a livello globale, prevede di arruolare circa 1.046 pazienti.
Zilovertamab vedotin è il coniugato anticorpo-farmaco sperimentale di Merck che mira a ROR1. L'endpoint primario dello studio è la sopravvivenza libera da progressione, con end-point secondari che includono il tasso di risposta completa, la sopravvivenza complessiva, la sopravvivenza libera da eventi, la durata della risposta completa e la sicurezza.
L'avvio segue risultati incoraggianti provenienti dal trial di Fase 2 waveLINE-007. Il farmaco è anche valutato nel trial di Fase 2/3 waveLINE-003 per DLBCL in recidiva o refrattario. Dati iniziali sono stati presentati al 66° Congresso Annuale della Società Americana di Ematologia nel dicembre 2024.
Merck (MRK) ha iniciado el ensayo clínico pivotal waveLINE-010, un ensayo de Fase 3 que evalúa zilovertamab vedotin en combinación con R-CHP en comparación con R-CHOP solo para pacientes con linfoma difuso de células B grandes (DLBCL) que nunca han sido tratados. El ensayo, que ha comenzado su reclutamiento a nivel mundial, inscribirá aproximadamente 1,046 pacientes.
Zilovertamab vedotin es el conjugado de anticuerpo-fármaco en investigación de Merck que se dirige a ROR1. El objetivo primario del estudio es la supervivencia libre de progresión, con objetivos secundarios que incluyen la tasa de respuesta completa, la supervivencia global, la supervivencia libre de eventos, la duración de la respuesta completa y la seguridad.
El inicio del ensayo sigue resultados alentadores del ensayo de Fase 2 waveLINE-007. El fármaco también se está evaluando en el ensayo de Fase 2/3 waveLINE-003 para DLBCL en recaída o refractario. Los datos iniciales se presentaron en la 66ª Reunión Anual de la Sociedad Americana de Hematología en diciembre de 2024.
머크 (MRK)는 이전에 치료받지 않은 미만형 대세포 림프종(DLBCL) 환자에 대한 R-CHP와 단독 R-CHOP 비교에서 zilovertamab vedotin의 병행 사용을 평가하는 중요한 3상 임상 시험인 waveLINE-010을 시작했다. 전 세계적으로 모집이 시작된 이 시험은 약 1,046명의 환자를 모집할 예정입니다.
Zilovertamab vedotin은 ROR1를 겨냥한 머크의 실험적 항체-약물 접합체입니다. 연구의 주요 목표는 무진행 생존으로, 이차 목표로는 완전 반응률, 전체 생존, 사건 없는 생존, 완전 반응 기간 및 안전성을 포함합니다.
이 시작은 2상 waveLINE-007 시험의 고무적인 결과를 뒤따릅니다. 이 약물은 재발 또는 불응성 DLBCL에 대한 2/3상 waveLINE-003 시험에서도 평가되고 있습니다. 초기 데이터는 2024년 12월 제66회 미국 혈액학회 연례회의에서 발표되었습니다.
Merck (MRK) a lancé l'essai clinique pivotal waveLINE-010, un essai de phase 3 évaluant le zilovertamab vedotin en combinaison avec R-CHP par rapport à R-CHOP seul chez des patients atteints de lymphome diffus à grandes cellules B (DLBCL) n'ayant jamais été traités. L'essai, qui a commencé le recrutement à l'échelle mondiale, comptera environ 1 046 patients.
Le zilovertamab vedotin est le conjugé anticorps-médicament investigational de Merck ciblant ROR1. L'objectif principal de l'étude est la survie sans progression, avec des objectifs secondaires comprenant le taux de réponse complète, la survie globale, la survie sans événement, la durée de la réponse complète et la sécurité.
Ce lancement fait suite à des résultats encourageants provenant de l'essai de phase 2 waveLINE-007. Le médicament est également évalué dans l'essai de phase 2/3 waveLINE-003 pour DLBCL en rechute ou réfractaire. Les données initiales ont été présentées lors de la 66e Réunion Annuelle de la Société Américaine d'Hématologie en décembre 2024.
Merck (MRK) hat die entscheidende Phase-3-Studie waveLINE-010 gestartet, die zilovertamab vedotin in Kombination mit R-CHP im Vergleich zu R-CHOP allein bei zuvor unbehandelten Patienten mit diffus großzelligen B-Zell-Lymphom (DLBCL) bewertet. Die Studie, die die globale Rekrutierung begonnen hat, wird voraussichtlich etwa 1.046 Patienten einschließen.
Zilovertamab vedotin ist der experimentelle Antikörper-Wirkstoff-Konjugat von Merck, der auf ROR1 abzielt. Der primäre Endpunkt der Studie ist das progressionsfreie Überleben, während die sekundären Endpunkte die komplette Ansprechraten, das Gesamtüberleben, das ereignisfreie Überleben, die Dauer des vollständigen Ansprechens und die Sicherheit umfassen.
Der Beginn folgt ermutigenden Ergebnissen aus der Phase-2-Studie waveLINE-007. Das Medikament wird auch in der Phase-2/3-Studie waveLINE-003 für rezidiviertes oder refraktäres DLBCL bewertet. Erste Daten wurden auf dem 66. Jahrestreffen der American Society of Hematology im Dezember 2024 präsentiert.
- Expansion of clinical development program into Phase 3 for DLBCL treatment
- Large-scale trial with 1,046 patient enrollment target
- Multiple ongoing trials across different phases showing pipeline progress
- Encouraging Phase 2 results leading to Phase 3 advancement
- None.
Insights
The initiation of Merck's Phase 3 waveLINE-010 trial marks a strategic move in the $7.9 billion DLBCL market, where R-CHOP has remained the standard first-line therapy for over 20 years. This large-scale trial with 1,046 patients demonstrates Merck's confidence in zilovertamab vedotin's potential, likely supported by promising Phase 2 data presented at ASH 2024.
The trial's design is particularly noteworthy for three reasons: First, targeting treatment-naive patients positions zilovertamab vedotin for maximum market impact as a first-line therapy. Second, the antibody-drug conjugate (ADC) technology represents a more precise approach compared to traditional chemotherapy, potentially offering improved efficacy with better safety profiles. Third, the elimination of vincristine from the combination (using R-CHP instead of R-CHOP) suggests a strategic effort to reduce peripheral neuropathy while maintaining therapeutic efficacy.
The trial's focus on progression-free survival as the primary endpoint, along with comprehensive secondary endpoints including overall survival and complete response rate, provides multiple pathways to demonstrate clinical benefit. This robust endpoint strategy increases the probability of achieving at least one positive outcome that could support regulatory approval.
For investors, this development carries significant weight because: 1) DLBCL represents the most common form of non-Hodgkin lymphoma, affecting approximately 150,000 new patients globally each year 2) Success in first-line therapy could establish zilovertamab vedotin as a new standard of care, potentially generating multi-billion dollar annual revenues 3) The expanding waveLINE program demonstrates Merck's commitment to building a strong presence in hematologic malignancies, diversifying beyond its current oncology portfolio.
Expansion of the waveLINE clinical development program demonstrates company’s progress in advancing research in hematologic malignancies
“Following the encouraging results observed in the Phase 2 waveLINE-007 trial, we look forward to evaluating the potential clinical benefits of a combination regimen with zilovertamab vedotin in patients with diffuse large B-cell lymphoma compared to the current standard treatment,” said Dr. Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories. “ADCs have shown promise as an important modality in the treatment of different cancer types, and the initiation of this Phase 3 waveLINE clinical trial demonstrates our commitment to researching zilovertamab vedotin to help address unmet needs for patients with this aggressive and most common form of non-Hodgkin lymphoma.”
WaveLINE-010 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT06717347), which is enrolling an estimated 1,046 patients globally. The primary endpoint is progression-free survival (PFS), and secondary endpoints include complete response (CR) rate at the end of the treatment, overall survival, event-free survival, duration of CR and safety.
Zilovertamab vedotin is currently being evaluated in the Phase 2/3 waveLINE-003 dose confirmation and expansion trial (NCT05139017) for the treatment of relapsed or refractory DLBCL and in the Phase 2 waveLINE-007 trial (NCT05406401) in combination with R-CHP in patients with previously untreated DLBCL. Merck recently presented data from this trial for the first time at the 66th American Society of Hematology Annual Meeting and Exposition in December 2024.
About diffuse large B-cell lymphoma
Lymphoma is cancer beginning in the lymphatic system – the network of organs, vessels and tissues that protects the body from infection. There are many subtypes of lymphoma, which is often categorized into two main types – Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). Diffuse large B-cell lymphoma, the most common form of NHL, is derived from white blood cells that grow rapidly and uncontrollably, enlarging the lymph nodes and often migrating to other parts of the body. DLBCL accounts for approximately 25
About zilovertamab vedotin (MK-2140)
Zilovertamab vedotin is an investigational ADC that targets ROR1. ROR1 is a transmembrane protein that is overexpressed in multiple hematologic malignancies. Merck is committed to research with zilovertamab vedotin across B-cell malignancies and is establishing a robust program of clinical trials under the name waveLINE. The waveLINE program includes a Phase 2/3 study in patients with relapsed or refractory DLBCL (waveLINE-003, NCT05139017) and a Phase 2 study in patients with previously untreated DLBCL (waveLINE-007, NCT05406401).
About Merck in hematology
Merck is committed to advancing innovation and care for people with hematologic neoplasms and malignancies. Building on its leadership in oncology, the company has a broad clinical development program that evaluates novel mechanisms of action to address longstanding unmet needs for patients with hematologic disorders. Among Merck’s research efforts are studies evaluating multiple investigational medicines as monotherapy or in combination with other therapies across a range of hematologic neoplasms and malignancies.
Merck’s focus on cancer
Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology.
About Merck
At Merck, known as MSD outside of
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