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)

Publication date: Available online 29 March 2019Source: The Lancet HaematologyAuthor(s): Franck Morschhauser, Ian W Flinn, Ranjana Advani, Laurie H Sehn, Catherine Diefenbach, Kathryn Kolibaba, Oliver W Press, Gilles Salles, Hervé Tilly, Andy I Chen, Sarit Assouline, Bruce D Cheson, Martin Dreyling, Anton Hagenbeek, Pier Luigi Zinzani, Surai Jones, Ji Cheng, Dan Lu, Elicia Penuel, Jamie HirataSummaryBackgroundAntibody–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.MethodsIn 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 rituximab plus 2·4 mg/kg ADCs) every 21 days until disease progression or unacceptable toxicity up to 1 year. Treatment allocations were not masked to the investigator, patients or sponsor after the patients were enrolled and randomly assigned. The primary objectives were safety and tolerability, and antitumour response. The study is registered with ClinicalTrials.gov, number NCT01691898, and is closed to accrual.Findings81 patients with diffuse large B-cell lymphoma and 42 with follicular lymphoma...
Source: The Lancet Haematology - Category: Hematology Source Type: research