OBJECTIVES: Venetoclax is a selective BCL2 inhibitor approved as treatment in combination with obinutuzumab (VenO) and rituximab (VenR) for frontline (1L) and second-line CLL (2L), respectively. This study aims to assess real-world treatment patterns and outcomes in community settings.

METHODS: We conducted a retrospective cohort study using ConcertAI EHR-derived de-identified database. Eligible patients (pts) were diagnosed with CLL in the community setting, received an approved venetoclax-based regimen in 1L/2L on or before 04/30/2021 in the US and had ≥12 months of activity. We evaluated patient characteristics, treatment patterns and time to next treatment or death (TTNT-D) by lines of therapy.

RESULTS: A total of 254 pts were included. Among 128 1L pts, VenO was the most common regimen (59.4%), followed by venetoclax monotherapy (VenMono) and VenR (37.5% and 3.1%, respectively). Most pts did not receive subsequent treatment (73.4%), driven by pts on VenO (93.4%). The median duration of therapy (mDOT) was 12.7, 19.9 and 3.2 months for VenO, VenR and VenMono, respectively. At a median follow-up (mFU) of 23.1 months, the median TTNT-D was not reached for pts on VenO and VenR regimens. The median TTNT-D for VenMono was 13.5 months.

Among 126 2L pts, 62% received a prior-BTKi. The most frequently prescribed 2L regimens were VenMono (65.1%), VenO (17.5%) and VenR (17.5%). Similar to 1L, 67.5% pts did not receive additional treatment. The mDOT was 22.1, 12.1 and 9.5 months among VenR, VenO and VenMono, respectively. With a mFU of 27.5 months, median TTNT-D was not reached for pts on VenR and VenO; median TTNT-D was 27.9 months for VenMono.

CONCLUSIONS: Venetoclax-based regimens are effective in real-world community settings, as seen with low rates of subsequent treatment initiation and significantly prolonged TTNT-D. This study confirms the real-world benefit of venetoclax-based regimens as demonstrated in clinical trials with respect to sustained treatment-free remission.