First results for zanubrutinib plus venetoclax in del(17p)/TP53-mutated CLL/SLL

The combination was associated with deep and durable responses in previously untreated high-risk CLL, SLL, and del(17p) and/or TP53 mutations.

Arm D of the SEQUOIA trial (NCT03336333) exposed 66 participants with CLL/SLL and del(17p) and/or TP53 mutations to the combination regimen of the Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib plus the B-cell lymphoma 2 (BCL-2) inhibitor venetoclax. Prof. Paolo Ghia (University Vita-Salute San Raffaele, Italy) presented the preliminary results of this study1.

After a median follow-up of 31.6 months, the overall response rate was 100 % and the complete remission (CR) plus CR with incomplete count recovery rate was 48 %. Importantly, the best undetectable minimal residual disease (<10-4) rate was 59 % in at least 1 peripheral blood sample. Finally, the median progression-free survival was not reached at this point. The estimated 24-month progression-free survival rate was 94 %.

COVID-19 (55 %), diarrhoea (39 %), nausea (30 %), contusion (29 %), and fatigue (23 %) were the most frequently observed side effects with the combination regimen. “The safety profile was overall favourable and we did not see any unexpected issues,” commented Prof. Ghia.

In conclusion, zanubrutinib plus venetoclax delivered promising preliminary efficacy results in participants with newly diagnosed CLL/SLL with del(17p) and/or TP53 mutations.

Medical writing support was provided by Robert van den Heuvel.

Source
  1. Ma S, et al. Combination of Zanubrutinib plus venetoclax for treatment-naïve CLL/SLL with del(17p) and/or TP53: preliminary results from SEQUOIA arm D. Abstract #S160, EHA congress 2024, 13–16 June, Madrid, Spain.