​CHICAGO—During an Oral Abstract Session on Tuesday, June 4, from 8:45 a.m. to 12:45 p.m., researchers from around the country will present data from a number of studies on chronic lymphocytic leukemia. Some of the highlights are listed below.

Acalabrutinib with obinutuzumab (Ob) in treatment-naive (TN) and relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): Three-year follow-up (Abstract 7500)

Acalabrutinib is a highly selective, potent, covalent Bruton tyrosine kinase inhibitor. In this phase Ib/II trial, it was evaluated with the CD20 antibody obinutuzumab in treatment-naive and relapsed/refractory CLL. The primary endpoints were overall response rate (ORR) and safety. In 28-day cycles, acalabrutinib was administered at 100 mg BID or 200 mg QD PO until progressive disease; obinutuzumab was given in standard fashion for 6 cycles starting with cycle 2. Jennifer Ann Woyach, MD, will present initial findings from the trial, which determined acalabrutinib plus obinutuzumab was well-tolerated and yielded high response rates that were durable and deepened over time among these patients.

TRANSCEND CLL 004: Minimal residual disease (MRD) negative responses after lisocabtagene maraleucel (Liso-Cel; JCAR017), a CD19-directed CAR T cell product, in patients (pts) with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) (Abstract 7501)

Tanya Siddiqi, MD, will present an oral abstract on CAR T-cell therapy for chronic lymphocytic leukemia (CLL). Lisocabtagene maraleucel, also known as liso-cel and JCAR017, targets CD19-positive cancer cells. Eligible patients had CLL/SLL, received ≥2 prior lines of therapy (including Bruton's tyrosine kinase inhibitors unless medically contraindicated), and had ECOG PS ≤1, researchers reported. At data cutoff, 16 patients received liso-cel: DL1, n=6; DL2, n=10. 75 percent of patients had high-risk features (TP53 mutation, complex karyotype, or del17p); 100 percent had prior ibrutinib; and 50 percent had prior venetoclax. "In this study of heavily pretreated patients with standard- and high-risk CLL/SLL and previous ibrutinib treatment, liso-cel-related toxicities were manageable." Additional follow-up will be presented during the session.

Effect of fixed-duration venetoclax plus obinutuzumab (VenG) on progression-free survival (PFS), and rates and duration of minimal residual disease negativity (MRD–) in previously untreated patients (pts) with chronic lymphocytic leukemia (CLL) and comorbidities (Abstract 7502)

The multinational, open-label, phase III CLL14 trial compared fixed-duration targeted VenG treatment with chlorambucil-obinutuzumab (ClbG) in previously untreated patients with CLL and comorbidities. In this session, Kirsten Fischer, MD, will present endpoint analyses focusing on MRD- and PFS. The study enrolled 432 patients—216 in each treatment group (intent-to-treat population). Researchers reported that after 29 months median follow-up, superior PFS was observed with VenG versus ClbG (HR 0.35; 95% CI 0.23-0.53; P<0.0001). Additionally, findings showed that MRD− by ASO-PCR was significantly higher with VenG compared to ClbG in both peripheral blood (76% vs 35% [P<0.0001]) and bone marrow (57% vs. 17% [P<0.0001]) 3 months after treatment completion. "Fixed-duration VenG induced deep (<10-6 in 1/3 of pts), high, and long-lasting MRD− rates (with a low rate of conversion to MRD+ status 1 year after treatment) in previously untreated patients with CLL and comorbidities, translating into improved PFS," according to study authors.



