Zilovertamab vedotin plus R-CHP versus R-CHOP for first-line treatment of diffuse large B-cell lymphoma: The phase 3 waveline-010 study
Notice bibliographique
Résumé
Abstract Introduction: Diffuse large B-cell lymphoma (DLBCL) is associated with 5-year survival rates ranging from 53% to 70%, highlighting the need for more effective frontline therapies. The current standard of care for previously untreated DLBCL is rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Zilovertamab vedotin is an ROR1-targeting antibody-drug conjugate with a monomethyl auristatin E payload that has shown encouraging antitumor activity in patients with DLBCL. The waveLINE-010 study (NCT06717347) is a randomized, open-label, phase 3 study designed to assess the efficacy and safety of zilovertamab vedotin in combination with rituximab plus cyclophosphamide, vincristine, and prednisone (R-CHP) versus R-CHOP in participants with previously untreated DLBCL. Methods: Eligible participants are aged ≥18 years and have a confirmed diagnosis of DLBCL per the World Health Organization classification of hematopoietic and lymphoid tissue neoplasms. DLBCL subtypes that are eligible for enrollment include DLBCL, not otherwise specified (NOS); DLBCL leg-type; Epstein-Barr virus–positive DLBCL; and T-cell histiocyte-rich DLBCL. Additional inclusion criteria include disease confirmed by positron emission tomography (score of 4-5 on the Lugano 5-point scale), an International Prognostic Index (IPI) score of 2-5, and an Eastern Cooperative Oncology Group performance status score of 0-2. Participants who received prior treatment for DLBCL will be excluded. Approximately 1046 participants will be enrolled and randomly assigned 1:1 to receive zilovertamab vedotin 1.75 mg/kg plus R-CHP on day 1 of every 3-week cycle for 6 cycles or R-CHOP on day 1 of every 3-week cycle for 6 cycles. Participants with high-risk DLBCL, with an IPI score of 3-5, will receive rituximab (or a rituximab biosimilar) for an additional 2 cycles. Randomization will be stratified by geographic region (Western Europe, United States, Canada, Australia vs Asia vs rest of world), IPI score (2 vs 3-5), and disease bulk (<7.5 cm vs ≥7.5 cm). Imaging assessments using computed tomography (CT) will be conducted after administration of study intervention between cycles 4 and 5, with a follow-up scan 12 weeks later to mark the end of treatment (EOT) assessment. Post-treatment efficacy follow-up CT scans will be performed every 24 weeks for 2 years from the EOT assessment, followed by annual scans for 3 additional years (total, 5 years). Adverse events (AEs) will be monitored throughout the study and for 30 days after EOT (90 days for serious AEs; or 30 days if new anticancer therapy is initiated). AEs will be graded per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Patient-reported outcomes measures will be administered before dosing on day 1 of every cycle, at the EOT visit, and at the 30-day safety follow-up visit. The primary end point is progression-free survival per Lugano response criteria by blinded independent central review (BICR). Secondary end points are complete response rate and duration of complete response per Lugano response criteria by BICR at EOT, event-free survival per Lugano criteria by BICR, overall survival, safety, and change from baseline in health-related quality of life. Recruitment is ongoing. ©2025 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2025 ASCO Annual Meeting. All rights reserved.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,002 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,005 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».