Found 1 Presentation For Request "826p"
826P - Encorafenib and binimetinib followed by radiotherapy for patients with symptomatic BRAF mutated melanoma brain metastases: GEM1802/E-BRAIN clinical trial
- Ivan Marquez-Rodas (Madrid, Spain)
Abstract
Background
Patients (pts) with symptomatic melanoma brain metastases (MBM) have very poor prognosis. For
Methods
15 pts were treated with 2 months of EB at standard dose. If intracranial partial response (PR) or stable disease (SD), brain RDT (radiosurgery (SRS) or whole brain RDT (WBRT) was offered according to local guidelines followed by EB. For pts with complete response (CR) RDT could be spare and used in a later progressive disease (PD). iRR, iPFS, overall survival (OS) and QoL (QLQ-C30) were analyzed.
Results
Table summarizes pts´ basal characteristics. iRR after 2 months of EB was 73.3% (6.7% CR and 66.7% PR) with 26.7% SD and no PD. 20% pts received SRS & 46.7% WBRT after 1st evaluation. With a median follow up of 11.8 months (m) (Range: 3.4-23.1) median iPFS was 9.3 m (95% CI: 7.6-NR) with 73.3 & 23.3% of pts progression free at 6 & 12m respectively. Median OS was 18.4m (95% CI: 12.1-NR) with 93.3, 72.7 & 62.3% of pts alive at 6, 12 & 18m respectively. 20% of pts experienced G3-4 toxicity from EB and 6.7% from RDT. Global health status, pain and insomnia scales improved compared to baseline at week 16 (
Median age (range) 49y (21-79) Sex 60% female Brain Tumor Burden (target lesions), mean (95%CI) 51.9 mm (32.9-70.9) % >ULN LDH 33.3 Number of target BMs (1 vs 2-3 vs >3) 33.3 - 46.7 - 20 Extracranial disease 93.3 ECOG 0-1 86.6 Basal steroids 93.3 Previous systemic treatment 13.3
Conclusions
EB achieve a significant iRR in pts with symptomatic brain
Clinical trial identification
NCT03898908.
Editorial acknowledgement
mFAR, the CRO of the trial, provided assistance in the writing of the abstract.
Legal entity responsible for the study
Spanish Melanoma Group (GEM).
Funding
Pierre Fabre.
Disclosure
I. Marquez-Rodas: Financial Interests, Personal, Advisory Board: BMS, MSD, Novartis, Pierre Fabre, Roche, GSK, AstraZeneca, Celgene, Regeneron, Sanofi, Merck Serono, Highligth Therapeutics, Bioline Rx, Sun Pharma; Financial Interests, Personal and Institutional, Invited Speaker, GEM1802 clinical trial: Pierre Fabre; Financial Interests, Institutional, Invited Speaker, GEM1801 clinical study: Novartis, BMS, Roche, Pierre Fabre, Incyte, MSD; Financial Interests, Institutional, Invited Speaker, National coordinator of Spotlight 203 clinical trial: Highlight Therapeutics; Non-Financial Interests, Invited Speaker: Spanish Melanoma Group. A.M. Arance Fernandez: Financial Interests, Personal, Advisory Board, Consultant /Advisory/ Speaker / Travel, Accommodations, Expenses/: Pierre Fabre, Novartis, Roche, BMS, MSD, Merck, Sanofi; Financial Interests, Personal and Institutional, Other, Research Funding: Pierre Fabre, Novartis, MSD, BMS, Merck, Roche, Sanofi; Financial Interests, Institutional, Other, Research Funding: Amgem. M.A. Berciano Guerrero: Financial Interests, Personal, Invited Speaker: BMS, MSD, Pierre Fabre, Roche, Pfizer, Sanofi, Eisai, PharmaMar, Kyowa Kirin; Financial Interests, Personal, Advisory Board: BMS, MSD, Pierre Fabre, Roche, Pfizer, Sanofi, Eisai, PharmaMar. M. Gonzalez Cao: Financial Interests, Personal, Invited Speaker: BMS, Roche, MSD, Novartis, Pierre Fabre, AstraZeneca. P. Sanchez Mauriño: Financial Interests, Personal, Other: Novartis, BMS, Pierre Fabre, Sanofi, MSD. A. Alvarez: Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Speaker’s Bureau: PharmaMar. A. Berrocal: Financial Interests, Personal, Advisory Board: BMS, MSD, Novartis, Roche, Pierre Fabre, Merck. All other authors have declared no conflicts of interest.