|The following article features coverage from the American Society of Clinical Oncology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Previously untreated patients with chronic lymphocytic leukemia (CLL) and coexisting conditions who received fixed-duration venetoclax plus obinutuzumab had better survival outcomes compared with fixed-duration chemoimmunotherapy, showed results from the international, open-label, phase 3 CLL14 trial.
The trial results were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, and concurrently published in the New England Journal of Medicine.1,2
The CLL14 trial (ClinicalTrials.gov Identifier: NCT02242942) included 432 previously untreated patients with CLL and coexisting conditions, and patients were randomly assigned treatment with fixed-duration venetoclax plus obinutuzumab (216 individuals) or fixed-duration chlorambucil plus obinutuzumab (216 individuals).
The most common grade 3/4 event was neutropenia, affecting approximately half of patients in each arm. The most common grade 3/4 infection was pneumonia, affecting 4% in each arm. The venetoclax plus obinutuzumab arm had a higher incidence of fatal adverse events compared with the chlorambucil plus obinutuzumab, but this difference was not statistically significant (8% vs 4%).
“The increased number of events occurred after completion of therapy,” said study presenter Kirsten Fischer, MD, of the University of Cologne.
The overall response rate was significantly higher for the venetoclax plus obinutuzumab arm compared with the chlorambucil plus obinutuzumab arm (84.7% vs 71.3%; P <.0007); the complete response rate was also significantly higher (49.5% vs 23.1%; P <.001).
At a median follow-up of 28 months, the median progression-free survival (PFS) favored the venetoclax plus obinutuzumab arm over the chlorambucil plus obinutuzumab arm (hazard ratio, 0.35; 95% CI, 0.23-0.53; P <.001). The venetoclax plus obinutuzumab arm also had a superior 24-month PFS rate compared with the chlorambucil plus obinutuzumab arm (88% vs 64%), and the PFS benefit was seen regardless of IGHV or TP53 mutational status.
“We showed that fixed-duration targeted therapy with venetoclax and obinutuzumab can be applied safely to elderly patients with CLL and with relevant comorbidity,” concluded Dr Fischer. “This treatment provides superior outcome compared to chlorambucil and obinutuzumab.”
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- Fischer K, Al-Sawaf O, Bahlo J, et al. 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. Presented at: 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 7502.
- Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions
- . N Engl J Med. doi: 10.1056/NEJMoa1815281