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A phase II , single‐arm, multicentre study of coltuximab ravtansine ( SAR 3419) and rituximab in patients with relapsed or refractory diffuse large B‐cell lymphoma
Author(s) -
Coiffier Bertrand,
Thieblemont Catherine,
Guibert Sophie,
Dupuis Jehan,
Ribrag Vincent,
Bouabdallah Réda,
Morschhauser Franck,
Navarro Robert,
Le Gouill Steven,
Haioun Corinne,
Houot Roch,
Casasnovas Olivier,
Holte Harald,
Lamy Thierry,
Broussais Florence,
Payrard Sandrine,
Hatteville Laurence,
Tilly Hervé
Publication year - 2016
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.13992
Subject(s) - rituximab , diffuse large b cell lymphoma , medicine , refractory (planetary science) , lymphoma , oncology , materials science , composite material
Summary In this phase II , multicentre, single‐arm study, 52 patients with relapsed/refractory diffuse large B‐cell lymphoma ( DLBCL ) received the anti‐ CD 19 antibody–drug conjugate coltuximab ravtansine (55 mg/m 2 ) and rituximab (375 mg/m 2 ) weekly for 4 weeks, then every 2 weeks for 8 weeks. The primary endpoint was objective response rate ( ORR ) by International Working Group Criteria. The primary objective was to reject the null hypothesis of an ORR of ≤40%. Among 45 evaluable patients, the ORR was 31·1% (80% confidence interval [ CI ]: 22·0–41·6%) and the primary objective was not met. The ORR appeared higher in patients with relapsed disease (58·3% [80% CI : 36·2–78·1%]) versus those refractory to their last (42·9% [80% CI : 17·0–72·1%]) or first‐line therapy (15·4% [80% CI : 6·9–28·4%]). Median progression‐free survival, overall survival and duration of response were 3·9 [80% CI : 3·22–3·98], 9·0 [80% CI : 6·47–13·67] and 8·6 (range: 0–18) months, respectively. The pharmacokinetics of both drugs were unaffected by co‐administration. Common adverse events included gastrointestinal disorders (52%) and asthenia (25%). No patients discontinued due to adverse events. In conclusion, coltuximab ravtansine with rituximab was well tolerated and yielded clinical responses in a subset of patients with relapsed/refractory DLBCL .