30May

Acalabrutinib in treatment-naïve CLL: Mature results from Ph II study demonstrating durable remissions and longterm tolerability

Acalabrutinib in treatment-na¨ıve chronic lymphocytic leukemia: Mature results from phase II study demonstrating durable remissions and longterm tolerability


Abstract Number : 8024

Abstract Type : Poster Discussion Session

Indication : Chronic Lymphocytic Leukemia

Intervention : Acalabrutinib

Company : Acerta Pharma, a member of the AstraZeneca group

Technology : Small molecule


Result :

Ninety-nine pts (n = 62 100 mg BID; n = 37 200 mg QD), were treated [median age: 64 years, 47% Rai stage 3–4 disease, 10% del(17p), 62% unmutated IGHV]. At median followup of 53 months (range, 1–59), 85 (86%) pts remain on treatment; most discontinuations were due to AEs (n = 6) or PD (n = 3 [n = 1 Richter transformation]). Most common AEs (any grade) were diarrhea (52%), headache (45%), upper respiratory tract infection (44%), arthralgia (42%), and contusion (42%). Allgrade and grade $3 ECIs included infection (84%, 15%), bleeding events (66%, 3%), and hypertension (22%, 11%). Atrial fibrillation (all grades) occurred in 5% of pts (incidence: 1% in years 1, 2, 4; 3% in year 3). SPMs excluding nonmelanoma skin (all grades) occurred in 11%. Serious AEs were reported in 38% of pts; those in . 2 pts were pneumonia (n = 4) and sepsis (n = 3). ORR was 97% (7% complete response; 90% partial response). Median TTR was 3.7 months (range, 2–22). Response rates were similar across high-risk groups. Median DOR and median EFS were not reached; 48-month DOR rate was 97% (95% CI, 90%–99%), and 48-month EFS rate was 90% (95% CI, 82%–94%). Conclusions: Long-term data from ACE-CL-001 further support the favorable results with acalabrutinib in phase 3 studies and demonstrate durable responses with no new long-term safety issues


Refer to Chronic Lymphocytic Leukemia Market report for detailed Insights.