The ECHELON-2 Trial: 5-year results of a randomized, double-blind, phase 3 study of brentuximab vedotin and CHP (A plus CHP) versus CHOP in frontline treatment of patients with CD30-positive peripheral T-cell lymphoma
Iyer, S. Trumper, L. O'Connor, O. A. Pro, B. Illidge, Timothy M Advani, R. Bartlett, N. L. Christensen, J. H. Morschhauser, F. Domingo-Domenech, E.
Iyer, S.
Trumper, L.
O'Connor, O. A.
Pro, B.
Illidge, Timothy M
Advani, R.
Bartlett, N. L.
Christensen, J. H.
Morschhauser, F.
Domingo-Domenech, E.
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Abstract
Objective: Brentuximab vedotin (BV) plus cyclophosphamide,
doxorubicin, and prednisone (A+CHP) signifi cantly prolonged
progression-free survival (PFS) and overall survival (OS) versus
cyclophosphamide, doxorubicin, vincristine, and prednisone
(CHOP) in patients with systemic anaplastic large-cell lymphoma
(sALCL) or other CD30-positive peripheral T-cell lymphomas
(PTCL) in ECHELON-2 (Horwitz S et al., Lancet 2019). We
report updated results; median follow-up was 47.6 months for
PFS and 66.8 months for OS. Design: This phase 3, double blind study (NCT01777152) randomized patients aged 18 years
with previously untreated CD30-positive PTCL (targeting 75% ±
5% with sALCL) to A+CHP or CHOP for 6 or 8 cycles. Primary
endpoint of PFS was assessed per investigator in this updated
analysis. Key secondary endpoints included OS and PFS in sALCL.
BV or BV-containing regimens were permitted as subsequent/
retreatment therapies. Results: 452 patients were enrolled (226
patients in each arm); 316 (70%) patients had sALCL. Patients
with advanced disease were included (stage III [27%] and stage IV
[53%]; International Prognostic Index 2 [78%]). Data continues
to favor A+CHP: HRs were 0.70 (95% CI: 0.53–0.91, P=0.0077)
for PFS per investigator and 0.72 (95% CI: 0.53–0.99, P=0.0424)
for OS. 5-year PFS was 51.4% (95% CI: 42.8–59.4) with A+CHP
versus 43.0% (95% CI: 35.8–50.0) with CHOP; median PFS was
62.3 months (95% CI: 42.0–not evaluable) with A+CHP and
23.8 months (95% CI: 13.6–60.8) with CHOP. 5-year OS was
70.1% (95% CI: 63.3–75.9) and 61.0% (95% CI: 54.0–67.3) with
A+CHP and CHOP, respectively. Median OS was not reached in
either arm. PFS favored A+CHP (HR: 0.55 [95% CI: 0.39–0.79]) in
sALCL. 29 (13%) and 54 (24%) patients with A+CHP and CHOP
received subsequent BV, respectively. Treatment-emergent peripheral
neuropathy (PN), resolved/improved in 72% (n=84/117) and 78%
(n=97/124) of patients with PN on A+CHP and CHOP, respectively;
98% and 97% of ongoing PN events were grade 1/2 with A+CHP
and CHOP, respectively. Conclusions: At this important 5-year
milestone, A+CHP still provides clinically meaningful improvement
in both PFS and OS versus CHOP, with a manageable safety profi le,
including continued resolution/improvement of PN.
Authors
Iyer, S.
Trumper, L.
O'Connor, O. A.
Pro, B.
Illidge, Timothy M
Advani, R.
Bartlett, N. L.
Christensen, J. H.
Morschhauser, F.
Domingo-Domenech, E.
Rossi, G.
Kim, W. S.
Feldman, T.
Menne, T.
Belada, D.
Illes, A.
Tobinai, K.
Tsukasaki, K.
Yeh, S. P.
Shustov, A.
Huttmann, A.
Savage, K. J.
Yuen, S.
Zinzani, P. L.
Miao, H.
Bunn, V.
Fenton, K.
Fanale, M.
Puhlmann, M.
Horwitz, S.
Trumper, L.
O'Connor, O. A.
Pro, B.
Illidge, Timothy M
Advani, R.
Bartlett, N. L.
Christensen, J. H.
Morschhauser, F.
Domingo-Domenech, E.
Rossi, G.
Kim, W. S.
Feldman, T.
Menne, T.
Belada, D.
Illes, A.
Tobinai, K.
Tsukasaki, K.
Yeh, S. P.
Shustov, A.
Huttmann, A.
Savage, K. J.
Yuen, S.
Zinzani, P. L.
Miao, H.
Bunn, V.
Fenton, K.
Fanale, M.
Puhlmann, M.
Horwitz, S.
Description
Date
2021
Publisher
Collections
Keywords
Type
Other
Citation
Iyer S, Trumper L, O'Connor OA, Pro B, Illidge T, Advani R, et al. The ECHELON-2 Trial: 5-Year Results of a Randomized, Double-Blind, Phase 3 Study of Brentuximab Vedotin and CHP (A plus CHP) Versus CHOP in Frontline Treatment of Patients with CD30-Positive Peripheral T-Cell Lymphoma. Clinical Lymphoma Myeloma & Leukemia. 2021;21:S411-S.