News in Chronic Lymphocytic Leukemia
ASCO 2016. Abstract 7520. Outcomes with ibrutinib by line of therapy in patients with CLL: Analyses from phase III data.
Susan Mary O’Brien et al.
Susan Mary O’Brien et al.
Results: We analyzed data from two phase 3 trials of ibr: PCYC-1115/16 (RESONATE-2) in pts ≥ 65 with treatment naïve (TN) CLL; PCYC-1112 (RESONATE) in previously treated (PT) CLL, excluding pts with del17p for a more homogenous dataset for analysis. Progression-free survival (PFS) and overall response rate (ORR) were assessed by investigator.
In TN vs PT patients, median (med) age was 73 vs 66 yrs. PT patients had med 3 prior therapies including CD20 antibody (93%), purine analog (87%), or alkylating agents (93%; bendamustine 41%). Med PFS and OS were not reached (NR) for TN or PT patients, with 89- 92% progression free at 2 yrs for pts treated with ibr in 1st- or 2nd- line. ORR was high regardless of LoT (91% in TN, 92% in PT patients). Most pts continue ibr. Adverse event (AE) pro le was similar for both groups. Pts receiving ibr in earlier LoT were less likely to DC ibr due to progression (PD). Med OS post ibr DC is NR for pts who received ibr in 1st- or 2nd-line (n = 23) vs 7-9 m in 3rd-line and beyond (n = 34).
Conclusions: Ibr led to favorable PFS and OS, and high ORR regardless of LoT in pts with CLL. Pts who received ibr in 1st- or 2nd-line were less likely to progress and experienced better post-ibr survival outcomes. Clinical trial information: NCT01578707 and NCT01722487
CARE™ FACULTY PERSPECTIVE: This trial combines the patients from multiple trials and compares ibrutinib-based therapy with standard therapies. It is not surprising to see that ibrutinib-treated patients treated as part of primary or second-line therapies appear to have higher rates of PFS compared to patients who receive treatment later in the disease course.
