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SYMPATICO: Ibrutinib plus venetoclax in relapsed/refractory MCL
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The combination of ibrutinib, a BTK inhibitor, and venetoclax, a BCL-2 inhibitor, has shown efficacy in MCL in early clinical trials.1 Results from the phase III SYMPATICO trial (NCT03112174) evaluating the efficacy and safety of ibrutinib-venetoclax in R/R MCL were published in The Lancet Oncology by Wang et al.1 A total of 267 patients were randomly assigned to receive ibrutinib-venetoclax (n = 134) or ibrutinib-placebo (n = 133).1 The primary endpoint was investigator-assessed PFS in the intention-to-treat population.1 |
| Key learnings |
| The ibrutinib-venetoclax group had a significantly longer median PFS (31.9 months vs 22.1 months; HR, 0.65; 95% CI, 0.47–0.88; p = 0.0052) and a higher estimated 24-month PFS rate (57% vs 45%) than the ibrutinib-placebo group. |
| The CRR was significantly higher in the ibrutinib-venetoclax vs ibrutinib-placebo group (54% vs 32%; p = 0.0004). The ORR was 82% vs 74%, with the median TTNT not reached vs 35.4 months (HR, 0.60; 95% CI, 0.40–0.89; p = 0.0096), respectively. |
| The most common Grade 3–4 AEs included neutropenia (31% vs 11%), thrombocytopenia (13% vs 8%), and pneumonia (12% vs 11%) in the ibrutinib-venetoclax and ibrutinib-placebo groups, respectively. |
| SAEs were reported in 60% of patients in each group, with treatment-related deaths reported in 2% of patients in each group. |
| Results from the SYMPATICO trial show that ibrutinib-venetoclax vs ibrutinib-placebo improved PFS, with higher ORR and CR rates in patients with R/R MCL, while maintaining a tolerable safety profile. |
Abbreviations: AE, adverse event; BTK, Bruton’s tyrosine kinase; BCL, B-cell lymphoma; CI, confidence interval; CRR, complete response rate; HR, hazard ratio; MCL, mantle cell lymphoma; ORR, overall response rate; PFS, progression-free survival; R/R, relapsed/refractory; SAE, serious adverse event; TTNT, time to next treatment.
- Wang M, Jurczak W, Trneny M, et al. Ibrutinib plus venetoclax in relapsed or refractory mantle cell lymphoma (SYMPATICO): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol. 2025;26(2):200-213. DOI: 10.1016/S1470-2045(24)00682-X
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