Combination treatment with targeted agents in CLL
(S804) HIGH RATE OF COMPLETE RESPONSE BUT MINIMAL RESIDUAL DISEASE STILL DETECTABLE AFTER FIRST-LINE TREATMENT COMBINING OBINUTUZUMAB AND IBRUTINIB IN CHRONIC LYMPHOCYTIC LEUKEMIA (CLL): ICLL07 FILO TRIAL
Anne-Sophie Michallet, et al. ABSTRACT
These preliminary results indicated that this 9 month « chemo-free » induction is associated with a high CR rate (41%) without excess of toxicity. However, the majority of the patients required subsequent immuno-chemotherapy because of detectable BM MRD.
(S805) HIGH, DURABLE MINIMAL RESIDUAL DISEASE (MRD) NEGATIVITY WITH VENETOCLAX + RITUXIMAB IN RELAPSED/REFRACTORY CLL: MRD KINETICS AND RESPONSES IN CYTOGENETIC RISK GROUPS IN PTS FROM PHASE 3 MURANO STUDY
Peter Hillmen, et al. ABSTRACT
The robust PB MRD and high concordance with BM MRD with VenR confirms the value of PB MRD for correlation with clinical outcome in patients with R/R CLL treated with this regimen. VenR achieves high, early, deep and durable PB MRD– regardless of risk features, unlike BR. Some reemergence of MRD+, mainly intermediate (10-4 to <10-2) level, is seen only in a small number of patients, and may not lead to clinical PD, consistent with the PFS benefit observed in the MURANO study. NCT02005471
Paolo Ghia, et al. ABSTRACT
These early study results support the safety, activity, and TLS risk reduction potential of ibr lead-in. The early data show promising activity of an I+V oral regimen with MRD(-) responses in 82% in first-line CLL. Safety profiles were consistent with AE profiles of single-agent ibr or ven. The protocol-specified efficacy analysis in the first 30 patients (including ORR) will be presented.
Matthew Davids, et al. ABSTRACT
dFCR is an effective regimen for the initial therapy of younger, fit CLL pts, leading to a high rate of BM-MRD negativity of 81%, although infectious and immune-mediated toxicities were observed.
Anthony R. Mato, et al. ABSTRACT
Umbralisib appears to be safe and effective in a KI intolerant CLL population. These are the first prospective data to confirm that switching from ibrutinib, acalabrutinib or idelalisib to an alternate PI3K-δ(umbralisib) can result in durable responses without recurrence of prior KI intolerance toxicities. Pre-umbralisib dosing samples are being analyzed for BTK resistance mutations and CYP-3A4 polymorphisms. Study enrollment is expected to be completed with 50 pts by the meeting.