ICML 2019 | CLL14 trial analysis
Othman Al-Sawaf, MD, University Hospital of Cologne, Cologne, Germany, discusses the general analysis of the CLL14 trial (NCT02242942), which investigated venetoclax-obinutuzumab for untreated chronic lymphocytic leukemia (CLL) patients with a higher age or reduced fitness. This interview took place at the 15th International Conference on Malignant Lymphoma (ICML), in Lugano, Switzerland.
Transcript (edited for clarity):
CLL14 is a randomized phase free trial that we conducted from 2014 to 2016, in which 432 patients were recruited to either receive chlorambucil-obinutuzumab over 12 cycles, or 12 cycles of veneto-obinutuzumab also a fixed duration treatment regimen. Patients were eligible if they had co-existing conditions which was assessed according to cumulative earnest rating scale. If they had 6 or more points on this source scale they were eligible to receive treatment within the clinical trial, and if they were previously untreated. We ultimately had 432 patients who did not have previous treatment who had clinically relevant coexisting conditions, and those patients were then treated for with this fixed duration regimen and the primary endpoint was progression-free survival for these patients.
We recruited quite quickly which indicated the urgent medical need for this particular group of patients which probably represents the biggest proportion of patients in CLL in general. The results of this clinical trial were quite clear. We did see that the primary endpoint was met last year, and we saw that there was a significant improvement of progression-free survival in patients receiving this chemotherapy-free regimen of venetoclax-obinutuzumab and it was significantly longer than patients receiving chlorambucil-obinutuzumab.
We also saw that this benefits of venetoclax- obinutuzumab was observed within all relevant major subgroups so we did see that patients with p53 aberrations benefited from this treatment, we did see that patients with unmutated IGSV status, also an adverse prognostic factor, also benefited from this chemotherapy-free regimen and we saw sustained deep molecular responses in all patients treated with venetoclax-obinutuzumab. Almost 80% of all patients had MRD negativity in the bone marrow which indicated these deep responses that we observed when treating with venetoclax.
Today we also saw in some deep analysis on the cytogenetic risk features of the patients. We saw that IGHV status was a predictive marker for patients who would particularly benefit from venetoclax-obinutuzumab and we also saw analyses on complex karyotype where again patients with venetoclax-obinutuzumab did seem to benefit particularly well from this regimen, so that we today see that when venetoclax-obinutuzumab should be a standard of care for patients with previously untreated CLL and co-existing conditions.
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