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Valemetostat for R/R PTCL: Results from phase II VALENTINE-PTCL01 trial
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The phase II VALENTINE-PTCL01 trial (NCT04703192) is a multicenter, open-label, single-arm trial of valemetostat, a dual EZH2/EZH1 inhibitor, evaluating the efficacy and safety of valemetostat in patients with R/R PTCL. Results from the trial were published in The Lancet Oncology by Zinzani et al.1 Overall, 133 patients received valemetostat 200 mg/day in 28-day cycles until disease progression or unacceptable toxicity; the primary efficacy endpoint was ORR.1 |
| Key learnings |
| With a median follow-up of 12.3 months, ORR was 44% (CR was 14%; PR was 29%). |
| The median DoR was 11.9 months; median PFS was 5.5 months, and the median OS was 17 months. |
| The most common Grade 3−4 AEs reported were thrombocytopenia (23%), anemia (19%), and neutropenia (17%). Serious TEAEs were reported in 40% of patients with PTCL; 7% of them were treatment related. No treatment-related deaths were reported. |
| Overall, promising efficacy and safety data from the VALENTINE-PTCL01 study suggests that valemetostat could be a viable treatment option for patients with R/R PTCL. |
Abbreviations: DoR, duration of response; ETP, early T-cell precursor; hyperCVAD, hyperfractionated cyclophosphamide, vincristine, doxorubicin, dexamethasone; LBL, lymphoblastic lymphoma; pegAsp, pegylated asparaginase; PFS, progression-free survival; OS, overall survival; T-ALL, T-cell acute lymphoblastic leukemia.
- Zinzani PL, Izutsu K, Mehta-Shah N, et al. Valemetostat for patients with relapsed or refractory peripheral T-cell lymphoma (VALENTINE-PTCL01): A multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2024. Online ahead of print. DOI: 10.1016/S1470-2045(24)00503-5
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