Title :

Polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed or refractory non-hodgkin lymphoma: final results from a phase 2 randomised study (romulus)

Author(s) :

Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Flinn, Ian W. [Auteur]
Advani, Ranjana [Auteur]
Sehn, Laurie H. [Auteur]
Diefenbach, Catherine [Auteur]
Kolibaba, Kathryn [Auteur]
Press, Oliver W. [Auteur]
Salles, Gilles [Auteur]
Tilly, Herve [Auteur]
Chen, Andy I. [Auteur]
Assouline, Sarit [Auteur]
Cheson, Bruce D. [Auteur]
Dreyling, Martin H. [Auteur]
Hagenbeek, Anton [Auteur]
Zinzani, Pier Luigi [Auteur]
Jones, Surai [Auteur]
Cheng, Ji [Auteur]
Lu, Dan [Auteur]
Penuel, Elicia [Auteur]
Hirata, Jamie [Auteur]
Wenger, Michael [Auteur]
Chu, Yu-Waye [Auteur]
Sharman, Jeff P. [Auteur]

Journal title :

The Lancet. Haematology

Abbreviated title :

Lancet Haematol

Publication date :

2019-03-29

ISSN :

2352-3026

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

BACKGROUND: Antibody-drug conjugates (ADCs) polatuzumab vedotin (pola) and pinatuzumab vedotin (pina) showed clinical activity and tolerability in phase 1 trials. The aim of this multicentre, open-label, phase 2 study was ...
Show more >BACKGROUND: Antibody-drug conjugates (ADCs) polatuzumab vedotin (pola) and pinatuzumab vedotin (pina) showed clinical activity and tolerability in phase 1 trials. The aim of this multicentre, open-label, phase 2 study was to compare rituximab plus pola (R-pola) or pina (R-pina) in patients with relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma. METHODS: In this phase 2 randomised study at 39 investigational sites in six countries, patients were randomly assigned (1:1), by use of a dynamic hierarchical randomisation scheme, to receive R-pola or R-pina (375 mg/m2 RESULTS: 81 patients with diffuse large B-cell lymphoma and 42 with follicular lymphoma were recruited between Sept 27, 2012, and Oct 10, 2013, and were assigned to treatment. 81 patients with diffuse large B-cell lymphoma and 41 patients with follicular lymphoma were eligible for analysis. Of the 42 patients with diffuse large B-cell lymphoma who received R-pina, 25 (60%, 95% CI 43-74) achieved an objective response and 11 (26%, 95% CI 14-42) achieved a complete response. Of the 39 patients in this cohort who received R-pola, 21 (54%, 95% CI 37-70) achieved an objective response, and eight (21%, 95% CI 9-36) achieved a complete response. Of the 21 patients in the follicular lymphoma cohort who received R-pina, 13 (62%, 95% CI 38-82) achieved an objective response, and one (5%, 95% CI 0·1-24) achieved a complete response. Of the 20 patients in this cohort who received R-pola, 14 (70%, 95% CI 46-88) achieved an objective response, and nine (45%, 95% CI 23-68) achieved a complete response. In the diffuse large B-cell lymphoma cohort, grade 3-5 adverse events occurred in 33 (79%) of 42 patients receiving R-pina (most common were neutropenia [29%] and hyperglycaemia [10%]; nine [21%] grade 5 adverse events, five of which were infection-related), and in 30 (77%) of 39 patients receiving R-pola (most common were neutropenia [23%], anaemia [8%] and diarrhoea [8%]; no grade 5 adverse events). In the follicular lymphoma cohort, grade 3-5 adverse events occurred in 13 (62%) of 21 patients receiving R-pina (most common were neutropenia [29%] and hyperglycaemia [14%]; no grade 5 adverse events) and in ten (50%) of 20 patients receiving R-pola (most common were neutropenia [15%] and diarrhoea [10%]; one grade 5 adverse event). CONCLUSIONS: R-pina and R-pola are potential treatment options in patients with relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma. Pola was selected by the study funder for further development in non-Hodgkin lymphoma, partly because of longer durations of response than pina, and an overall benefit-risk favouring R-pola. BACKGROUND: F Hoffmann-La Roche.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
Université de Lille

Collections :

• Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365

Research team(s) :

Modélisation biopharmaceutique et pharmacocinétique

Submission date :

2019-12-16T14:06:39Z