Table 2 Key clinical trials of approved BCL-2 inhibitors for the treatment of CLL

Venetoclax (second-line or later monotherapy)

NCT01889186

Phase 2 single-arm study of the safety and efficacy of venetoclax in patients with del(17p) relapsed or refractory CLL

 ORR: 12.1-month median follow-up, 79.4%; final, 77%

 24-month PFS: 54%

 SAEs: 12.1-month median follow-up, 55%; final, 58%

[49, 50]

Venetoclax (first-line combination therapy)

CLL14 (NCT02242942)

Phase 3 study of the efficacy and safety of venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab in treatment-naïve patients with CLL who have coexisting conditions

Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab:

 24-month PFS: 88.2% versus 64.1%

  Results were similar for TP53 deletion/mutation or unmutated IGHV

 Grade ≥ 3 AEs: 78.8% versus 76.6%

[51]

Venetoclax (second-line or greater combination therapy)

MURANO (NCT02005471)

Phase 3 study of the efficacy and safety of venetoclax plus rituximab versus bendamustine plus rituximab in patients with relapsed or refractory CLL/SLL

Venetoclax plus rituximab versus bendamustine plus rituximab:

 24-month PFS: 84.9% versus 36.3%

  Results were similar for TP53 deletion or unmutated IGHV

 Grade ≥ 3 AEs: 82.0% versus 70.2%

[50]