Phase 2 study of acalabrutinib in ibrutinib intolerant patients with relapsed/refractory CLL

[Jm954]

This is another study reporting that Acalabrutinib is effective in patients who are intolerant of Ibruitnib.

This Phase 2 trial evaluated acalabrutinib, a highly selective, potent, covalent BTK inhibitor, in IBR-intolerant pts with R/R CLL.

Pts with R/R CLL (≥1 prior therapy) who discontinued IBR due to Grade 3/4 Adverse Events or persistent/recurrent Grade 2 AEs and had progressive disease (PD) after IBR discontinuation were eligible. Acalabrutinib was given at 100 mg BID PO in 28-d cycles until PD or unacceptable toxicity. The primary endpoint was overall response rate (ORR).

60 pts were treated (median age 70 y [range 43-88]). Pt characteristics included bulky disease ≥5 cm (33%), Rai stage III/IV (47%), del17p (28%), del11q (23%) and unmutated IGHV (79%).

52/55 (95%) pts with available baseline samples were wild type for BTK and PLCG2. Median number of prior therapies was 2 (range 1-10). Median duration of prior IBR therapy was 6 mo (range <1-55); common AEs that led to IBR discontinuation were atrial fibrillation/flutter (25%), diarrhea (12%), arthralgia (10%) and rash (12%). At a median follow-up of 19 mo (range 1-31), 67% of pts remained on acalabrutinib.

The ORR was 77% with the Median PFS not reached.

ascopubs.org/doi/abs/10.120...

The previous report was in 2016 when Justasheet1 posted about Acalabrutinib

healthunlocked.com/cllsuppo...

Jackie