Ibrutinib plus venetoclax for patients with MCL and TP53 mutations: Results from the SYMPATICO trial

Results from the phase III SYMPATICO trial (NCT03112174) of ibrutinib plus venetoclax in patients with mantle cell lymphoma (MCL) and TP53 mutations (n = 74; relapsed/refractory, n = 45; first line, n = 29) were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting by Wang.¹

In the SYMPATICO trial, the median time in the study for the overall population of patients with MCL and TP53 mutations was 40 months, with a median treatment duration of 15.9 months.

The median progression-free survival and overall survival rates were 20.9 and 47.1 months, respectively.

The overall response rate was 84%, and the complete response rate was 57%. 

Outcomes were generally comparable in first-line and relapsed/refractory MCL. 

The safety profile of ibrutinib plus venetoclax was consistent with that of the individual agents.

The most frequent Grade ≥3 adverse events (in ≥10% of patients) were neutropenia (32%), anemia, and thrombocytopenia (15% each). 

The results from the SYMPATICO trial suggest that ibrutinib plus venetoclax could be a viable therapeutic option for the treatment of patients with MCL and TP53 mutations, a patient population for whom treatment with standard chemoimmunotherapy provides poor responses and short survival outcomes.