A COMPREHENSIVE GLOBAL SYSTEMATIC LITERATURE REVIEW OF REAL-WORLD EVIDENCE OF RELAPSED/REFRACTORY AND POST-BRUTON TYROSINE KINASE INHIBITOR MANTLE CELL LYMPHOMA
Author(s)
Alvaro Alencar, MD1, Swetha Challagulla, MS2, Catarina Abreu, MPH3, Jin Kim, MS3, Madeline Dec, MPH3, Wesley Furnback, BS3, Keri Yang, PhD, MBA, MPH2;
1University of Miami Sylvester Comprehensive Cancer Center, Miami, FL, USA, 2BeOne Medicines USA, Inc., San Carlos, CA, USA, 3Real Chemistry, Inc., New York, NY, USA
1University of Miami Sylvester Comprehensive Cancer Center, Miami, FL, USA, 2BeOne Medicines USA, Inc., San Carlos, CA, USA, 3Real Chemistry, Inc., New York, NY, USA
OBJECTIVES: There is limited real-world evidence (RWE) in the management of mantle cell lymphoma (MCL), a rare, aggressive lymphoma characterized by frequent relapsed/refractory (R/R) disease. This study aims to conduct a systematic literature review (SLR) to examine real-world data in the R/R post-Bruton tyrosine kinase inhibitor (BTKi) treatment settings.
METHODS: A global SLR of Embase, PubMed, and CENTRAL databases was conducted to identify RWE including publications and abstracts in R/R and post-BTKi MCL (1/1/2020-4/30/2025). Studies were included if they reported >1 of the following real-world outcomes: overall response rate (ORR), complete response (CR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), time to next treatment (TTNT), discontinuation, adherence, healthcare-resource utilization (HCRU), costs, or patient-reported outcomes (PRO).
RESULTS: Forty-four R/R MCL studies were identified, including 18 in post-BTKi setting. Most used medical records/claims (n=43) and published in Europe (n=20) and US (n=18). In R/R MCL, commonly reported real-world outcomes included OS (n=37), PFS (n=29), CR (n=27), and ORR (n=26). Less frequently reported were discontinuation (n=17), DOR (n=9), HCRU (n=7), cost (n=4), TTNT (n=4), and adherence (n=2). Real-world PROs were not identified. BTKis were the most evaluated regimens (n=19). In the post-BTKi setting, PFS was frequently reported (n=16), followed by OS (n=14), DOR (n=11), ORR (n=11), CR (n=10), discontinuation (n=4), HCRU (n=2), and cost (n=1). Adherence, TTNT, and HCRU were not reported in post-BTKi setting. Median OS ranged from 1.4-105 months (R/R) and 5-24 months (post-BTKi); median PFS ranged 2.2-28 months and 3.7-16.2 months, respectively. ORR ranged 26.9-100% (R/R) and 23.1-90.9% (post-BTKi). Median TTNT ranged from 0.4-22.7 months (R/R). HCRU focused on hospitalizations; annual total costs ranged from $141,958-$365,892 in R/R MCL.
CONCLUSIONS: This SLR found incomplete reporting of RWE in R/R and post-BTKi MCL, with gaps in outcome reporting, especially in post-BTKi patients highlighting the need for further research.
METHODS: A global SLR of Embase, PubMed, and CENTRAL databases was conducted to identify RWE including publications and abstracts in R/R and post-BTKi MCL (1/1/2020-4/30/2025). Studies were included if they reported >1 of the following real-world outcomes: overall response rate (ORR), complete response (CR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), time to next treatment (TTNT), discontinuation, adherence, healthcare-resource utilization (HCRU), costs, or patient-reported outcomes (PRO).
RESULTS: Forty-four R/R MCL studies were identified, including 18 in post-BTKi setting. Most used medical records/claims (n=43) and published in Europe (n=20) and US (n=18). In R/R MCL, commonly reported real-world outcomes included OS (n=37), PFS (n=29), CR (n=27), and ORR (n=26). Less frequently reported were discontinuation (n=17), DOR (n=9), HCRU (n=7), cost (n=4), TTNT (n=4), and adherence (n=2). Real-world PROs were not identified. BTKis were the most evaluated regimens (n=19). In the post-BTKi setting, PFS was frequently reported (n=16), followed by OS (n=14), DOR (n=11), ORR (n=11), CR (n=10), discontinuation (n=4), HCRU (n=2), and cost (n=1). Adherence, TTNT, and HCRU were not reported in post-BTKi setting. Median OS ranged from 1.4-105 months (R/R) and 5-24 months (post-BTKi); median PFS ranged 2.2-28 months and 3.7-16.2 months, respectively. ORR ranged 26.9-100% (R/R) and 23.1-90.9% (post-BTKi). Median TTNT ranged from 0.4-22.7 months (R/R). HCRU focused on hospitalizations; annual total costs ranged from $141,958-$365,892 in R/R MCL.
CONCLUSIONS: This SLR found incomplete reporting of RWE in R/R and post-BTKi MCL, with gaps in outcome reporting, especially in post-BTKi patients highlighting the need for further research.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
RWD14
Topic
Real World Data & Information Systems
Topic Subcategory
Health & Insurance Records Systems
Disease
SDC: Oncology, SDC: Rare & Orphan Diseases