S102 POLATUZUMAB VEDOTIN (POLA) + OBINUTUZUMAB (G) AND LENALIDOMIDE (LEN) IN PATIENTS (PTS) WITH RELAPSED/REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL): INTERIM ANALYSIS OF A PHASE IB/II TRIAL
Notice bibliographique
Résumé
Background: Pola‐G‐Len has the potential to enhance anti‐tumor immune response in R/R FL. Here, we report a pre‐planned interim analysis of a phase Ib/II study (NCT02600897) of Pola‐G‐Len in pts with R/R FL. Aims: To assess the safety and efficacy of induction and maintenance with Pola‐G‐Len in pts with R/R FL. Methods: This is an ongoing, open‐label, multicenter study of pts with R/R FL (excluding grade [Gr] 3b) who have received ≥1 prior anti‐CD20 antibody‐containing chemo‐immunotherapy regimen. The study comprises an initial 3+3 dose‐escalation (DE) phase (to determine the recommended phase II dose [RP2D] of both Pola and Len for the Pola‐G‐Len regimen) followed by an expansion phase to assess the RP2D of Pola and Len. Pts received induction treatment with 6x 28‐day (D) cycles (C) of: G 1000 mg IV (C1: D1, D8, D15; C2‐6: D1); Pola 1.4 mg/kg or 1.8 mg/kg (DE) or RP2D (expansion) IV (D1); and Len 10–20 mg (DE) or RP2D (expansion) PO (D1‐21). Pts with complete response (CR)/partial response (PR)/stable disease (SD) at the end of induction (EOI) received G 1000 mg (D1 every 2mo, for 24mo), and Len (10 mg, D1‐21 monthly, 12mo). Primary endpoints were C1 dose‐limiting toxicities (DLTs), safety/tolerability, CR rate at EOI (modified Lugano criteria). Results: At the interim data cut‐off (6 July 2018), 52 pts were enrolled: 9 discontinued the study (adverse events [AE], n = 3; death due to PD, n = 4; pt withdrawal, n = 1; other, n = 1). At baseline, the median pt age was 62 (range 32–87) years; 60% were male; 58% had FLIPI Gr 3–5; 79% had received ≥2 prior therapy lines; 50% were refractory to their last treatment; 17% had bulky disease (≥7 cm). Two DLTs were reported in the cohort receiving Pola 1.8 mg/kg + Len 10 mg during the DE period (Gr 4 lipase/amylase elevation; asymptomatic, resolved with supportive care; Gr 3 thrombocytopenia leading to a delay in the initiation of cycle 2). Therefore, Pola 1.4 mg/kg + Len 20 mg was selected as the RP2D for expansion. Gr ≥3 AEs were experienced by 75% of pts: neutropenia (46%), thrombocytopenia (17%), anemia (12%) and infections (12%) were the most common AEs. AEs leading to Len dose reduction or interruption occurred in 31% and 52% of pts, respectively. One Gr 5 AE was reported (septic shock after PD in pt receiving subsequent therapy). The RP2D was determined as Pola 1.4 mg/kg + Len 20 mg. Preliminary efficacy data suggest high activity, with an independent review committee‐assessed Modified Lugano response rate of 89% and a CR rate of 67% (Table). Median progression‐free survival was not reached (median follow‐up duration 8.95 mo in the efficacy‐evaluable population). image Summary/Conclusion: The safety profile of Pola‐G‐Len is consistent with known profiles of the individual drugs. Response rates at EOI with Pola‐G‐Len are promising, with high CR compared with available R/R FL treatments.
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 distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
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 tête enseignante, 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 ».