Anthony Mato, MD of Memorial Sloan Kettering Cancer Center discusses ASH 2020 abstract – Oral presentation looking at real-world data from CLL patients on the informCLL registry (Abstract #547).
Context:
Treatment choices for pts with CLL have progressed and expanded with the advent of novel agents, along with guidance. The informCLLTM registry is the largest prospective observational registry of pts located in the US that received CLL/SLL treatment in the post-novel agent period. In order to analyze the effect of the complex care landscape, treatment practices, and findings in routine clinical settings, this prospective real-world registry is ideally placed. Baseline features, prognostic biomarker testing, and clinical patterns for the fully enrolled population of pt are discussed here.
Methodology:
InformCLL (PCYC-1134; NCT02582879) enrolled qualified CLL/SLL pts who were >18 years (y) from Oct 2015 to June 2019, initiated FDA-approved CLL/SLL treatment within ±45 days of enrollment and given consent. Pts were divided into 5 treatment-based classes obtained at registration (index): ibrutinib (single or combination agent), chemoimmunotherapy (CIT), chemotherapy (CT), immunotherapy (IT), and other novel agents. There are descriptive analyses provided.
Outcomes:
With 1461 pts, the registry was fully registered: 855 (59%) previously untreated and 606 (41%) relapsed/refractory (R/R) pts. 93% of pts were registered through community-based practices. The median age was 71 y (33% ⇠75 y), the majority was male (64%), and 88% had 0/1 ECOG success status. 51 percent had Rai stage III/IV for pts with staging conducted at enrollment (n=852). For previously untreated pts, the median (range) period from diagnosis to initial study care was 18.6 months (mos, <0.1−471.3); the median time from diagnosis to index treatment was 84.27 mos (1.1−469.4) for R/R pts. The median follow-up (range) for previously untreated pts was 14.9 mos (0.03−46.9) and for R/R pts was 15.3 mos (0.03−44.0).
In 28% (n=415) of pts, FISH testing was conducted and was more common in previously untreated vs. R/R pts (33 percent vs 21 percent ). In 11 percent (n=162) of pts, TP53 mutation testing was performed (previously untreated: 13 percent; R/R: 9 percent). IGHV mutational status testing was performed in 12 percent (n=171) of pts (previously untreated: 13 percent; R/R 10 percent). 24 percent (100/415) had del(17p), 27 percent (43/162) had TP53 mutation, and 71 percent (121/171) had unmutated IGHV from pts with prognostic biomarker monitoring.
Findings:
In the era of novel agents, the InformCLL registry offers an opportunity to prospectively analyze CLL treatment trends. The most common index medication was ibrutinib, and the majority of pts treated with ibrutinib remained on 2-year follow-up therapy; one-third of patients also received CIT (primarily BR). Particularly for TP53 and IGHV mutational status, the prognostic biomarker testing rates were low. InformCLL data also reveals an ‘awareness gap in terms of prognostic marker testing and therapy selection for pts with high-risk disease. The ongoing assessment of real-world treatment decisions and pt care that can not be answered by data from randomized clinical trials will enable data from the now full pt population and with ongoing follow-up.