التفاصيل البيبلوغرافية
| العنوان: |
ATIM-12. PHASE 2 STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF MEDI4736 (DURVALUMAB [DUR]) IN PATIENTS WITH BEVACIZUMAB (BEV)-REFRACTORY RECURRENT GLIOBLASTOMA (GBM) |
| المؤلفون: |
Reardon, David, Kaley, Thomas, Dietrich, Jorg, Clarke, Jennifer, Dunn, Gavin, Lim, Michael, Cloughesy, Timothy, Gan, Hui, Park, Andrew, Schwarzenberger, Paul, Ricciardi, Toni, Macri, Mary, Ryan, Aileen, Venhaus, Ralph |
| المصدر: |
Neuro-Oncology, vol 19, iss Suppl 6 |
| بيانات النشر: |
eScholarship, University of California |
| سنة النشر: |
2017 |
| المجموعة: |
University of California: eScholarship |
| الوصف: |
BACKGROUND GBM patients who progress on BEV, an approved angiogenesis inhibitor for recurrent GBM, have a dismal outcome with a median survival of < 6months. DUR is a human IgG1 monoclonal Ab against PD-L1. METHODS This ongoing Phase 2 open-label study (NCT02336165) evaluates safety and efficacy of DUR (10mg/kg every 2 weeks [Q2W]) in 5 GBM cohorts. Results are presented for Cohort C (DUR + continuing BEV 10mg/kg Q2W in BEV-refractory recurrent GBM). The primary efficacy endpoint for Cohort C is overall survival at 6months (OS-6), based on modified RANO criteria by investigator assessment; secondary endpoints include safety/tolerability and progression-free survival (PFS). The Intent-to-treat population includes patients receiving any dose of DUR and having at least baseline and 1 post-baseline tumor assessment. RESULTS First patient treated: 24 Mar 2015; data cutoff: 15 Mar 2017. Cohort C completed enrollment of 22 patients (male: 63.6%; mean age: 54.8 [37–77] years; baseline ECOG PS0: 27.3%, PS1: 68.2%; baseline measurable lesions: 81.8%). Treatment-emergent adverse events (TEAEs) occurred in 19 (86.4%) patients and most commonly included neurologic events associated with GBM. Treatment-related AEs (TRAEs) occurred in 10 (45.5%) patients, and incidences by maximum CTCAE grade (Gr) were Gr1: 5 (22.7%); Gr2: 4 (18.2%); Gr3: 1 (4.5%; fatigue); and Gr4/5: 0 patients. Most common TRAEs (≥2 [9.1%] patients) were fatigue, increased ALT, constipation, and headache. All patients (n=22) were evaluable for efficacy: OS range, 0.9 - 51.6 weeks; 8 patients (36%) had OS ≥ 22 weeks; PFS range, 0.9 -24.4 weeks; 11 patients (50%) had PFS ≥ 8 weeks; 3 patients were still alive at cutoff date; OS-6 to follow. CONCLUSIONS DUR + continuing BEV therapy appears to be well tolerated and shows preliminary activity in BEV-refractory recurrent GBM. Further studies are warranted. |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
unknown |
| العلاقة: |
qt7fz358pb; https://escholarship.org/uc/item/7fz358pbTest |
| الإتاحة: |
https://escholarship.org/uc/item/7fz358pbTest |
| حقوق: |
public |
| رقم الانضمام: |
edsbas.68AE6C90 |
| قاعدة البيانات: |
BASE |
