Brentuximab Vedotin addition to Gemcitabine in Relapsed or Refractory Peripheral T-cell Lymphoma: a LYSA Phase II Study.
(2025) Blood Advances — Vol. 9, n° 24, p. 6292-6304 (2025)
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Tournilhac, Olivier 
Lecolant, Solene Damaj, Gandhi Laurent
- Abstract
- (en) We aim to evaluate the efficacy of brentuximab vedotin (BV) combined with gemcitabine followed by BV maintenance in relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL). Patients (pts) with at least 5% CD30-positive cells by immunohistochemistry received 4 GBV induction (28d) cycles of gemcitabine 1000 mg/m2 (d1;d15) plus BV 1.8 mg/kg (d8) followed in responding pts by up to 12 BV maintenance (21d) cycles. Primary end point was overall response rate (ORR) after 4 induction cycles by CT-scan-based Lugano criteria. Of the 71 enrolled pts (median age of 66 years), 80.3% had received 1 prior line, 60.6% were refractory. The diagnoses per pathology central review were TFHL (47.9%), ALCL, [ALK- (19.7%) and ALK+ (7%)], PTCL-NOS (12.7%) and other entities (12.7%). In the intention-to-treat analysis, ORR was 46.5% with 19.7% complete response. Twenty-eight pts received maintenance. Grade 3-4 adverse events reported in ≥10% of pts during induction comprised: of neutropenia (55%), thrombocytopenia (14%), anemia (21%), infection (14%); during maintenance comprised of neutropenia (39%), thrombocytopenia (21%) and peripheral neuropathy (14%). With a median follow-up of 32.6 months, the median duration of response (DOR), progression-free (PFS) and overall survival were 15.8, 4.5 and 12.9 months, respectively. Efficacy, higher in ALCL, was present in the TFHL and PTCL-NOS group with and ORR, CR, PFS and DOR of 37.2%, 18.6%, 4 and 12.5 months, respectively. A negative association of high baseline soluble CD30 on both response and survival was found, which in ad hoc analysis appeared highly relevant in TFHL and PTCL-NOS patients. EudraCT 2017-000409-1 and NCT03496779.
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Citations
Tournilhac, O., Bouabdallah, K., Lecolant, S., Hacini, M., Laribi, K., Bailly, S., Belmondo, T., Maerevoet, M. M. F., Ysebaert, L., Guidez, S., Le Gouill, S., Bonnet, C., André, M., Dupuis, J., Thieblemont, C., Bachy, E., Daguindau, N., Morschhauser, F., Tricot, S., et al. (2025). Brentuximab Vedotin addition to Gemcitabine in Relapsed or Refractory Peripheral T-cell Lymphoma: a LYSA Phase II Study. Blood Advances, 9(24), 6292-6304. https://doi.org/10.1182/bloodadvances.2024015787 (Original work published 2025)