Objective responses in relapsed T-cell lymphomas with single agent brentuximab vedotin
Mené sur 35 patients atteints d'un lymphome T périphérique CD30+ récidivant et/ou réfractaire, cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse objective, et la toxicité du brentuximab vendotin
This phase 2, open-label, multicenter study evaluated the efficacy and safety of brentuximab vedotin, a CD30-directed antibody-drug conjugate, in relapsed/refractory CD30+ non-Hodgkin lymphomas (NCT01421667). The primary endpoint was objective response rate (ORR). Key secondary endpoints included safety, correlation of CD30 expression with response, response duration, and progression-free survival (PFS). Brentuximab vedotin 1.8 mg/kg was administered every 3 weeks until disease progression or unacceptable toxicity. This planned subset analysis included patients enrolled on study with peripheral T-cell lymphomas (PTCLs) (n=35). Diagnoses included angioimmunoblastic T-cell lymphoma (AITL, n=13) and PTCL not otherwise specified (n=22). Median age was 64 years and 63% were refractory to most recent therapy. Of 34 evaluable patients, the ORR was 41% (8 complete remissions [CR], 6 partial remissions [PR]), and the ORR was 54% in AITL (5 CR, 2 PR) with a median PFS of 6.7 months thus far. No correlation between CD30 expression per central review and response was observed. Safety data were generally consistent with the known profile of brentuximab vedotin. The most frequently occurring ≥ Grade 3 events were neutropenia (14%), peripheral sensory neuropathy, and hyperkalemia (9% each). In summary, brentuximab vedotin showed antitumor activity in patients with relapsed PTCL overall, particularly AITL. This study was registered at ClinicalTrials.gov, identifier: NCT01421667.