Phase 3 SYMPATICO Trial Shows Significant PFS Improvement with Ibrutinib-Venetoclax Combination in Relapsed/Refractory Mantle Cell Lymphoma

▎WuXi

Edited by Kant Content Team

Positive Results of SYMPATICO Phase 3 Clinical Trial Reported in Recently Published Abstracts at the 2023 American Society of Hematology (ASH) Annual Meeting. The trial evaluated the combination of Imbruvica (ibrutinib), co-developed by Johnson & Johnson and AbbVie, and Venclexta (venetoclax), co-developed by AbbVie and Genentech, a subsidiary of Roche, for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least one prior line of therapy.Analysis shows that, compared with Imbruvica monotherapy, patients receiving the combination therapy demonstrated a statistically significant improvement in progression-free survival (PFS).

The analysis shows,The median PFS for patients (n=134) receiving both Imbruvica and Venclexta was 31.9 months, compared to 22.1 months for those (n=133) on Imbruvica monotherapy, a difference that was statistically significant (HR=0.65, 95% CI: 0.47-0.88, P=0.0052).The PFS benefit in the combination therapy group was consistent across different patient subgroups, including MCL patients with TP53-mutated tumors and those with blastoid variant disease.

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PFS Analysis Results of the SYMPATICO Trial (Source: Reference [1])

In addition, the combination therapy group (54%) had a significantly higher complete response (CR) rate than the monotherapy group (32%) (P=0.0004). The median overall survival (OS) was 44.9 months in the combination therapy group and 38.6 months in the control group receiving only Imbruvica monotherapy.

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Efficacy Summary of the SYMPATICO Trial (Image Source: Reference [1])

In terms of safety,84% UtilizationPatients on the combination treatment regimen experienced grade 3 or higher adverse events, compared to 76% in the control group. The most common toxicities included neutropenia, pneumonia, thrombocytopenia, anemia, and diarrhea.

Imbruvica is a Bruton's tyrosine kinase (BTK) inhibitor., exerts its effect by inhibiting the proliferation of malignant B cells,Venclexta is a “first-in-class” BCL-2 inhibitor.

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According to the abstract to be presented at the ASH Annual Meeting, these two therapies have distinct and complementary mechanisms of action.

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