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|Ref Type||Journal Article|
|Authors||Jurczak W, Zinzani PL, Gaidano G, Goy A, Provencio M, Nagy Z, Robak T, Maddocks K, Buske C, Ambarkhane S, Winderlich M, Dirnberger-Hertweck M, Korolkiewicz R, Blum KA|
|Title||Phase IIa study of the CD19 antibody MOR208 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.|
|Journal||Annals of oncology : official journal of the European Society for Medical Oncology|
|Date||2018 05 01|
|Abstract Text||This two-stage, phase IIa study investigated the antitumor activity and safety of MOR208, an Fc-engineered, humanized, CD19 antibody, in patients with relapsed or refractory (R-R) B-cell non-Hodgkin's lymphoma (NHL). CD19 is broadly expressed across the B-lymphocyte lineage, including in B-cell malignancies, but not by hematological stem cells.Patients aged ≥18 years, with R-R NHL progressing after ≥1 prior rituximab-containing regimen were enrolled into subtype-specific cohorts: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), other indolent (i)NHL and mantle cell lymphoma (MCL). Treatment was MOR208, 12 mg/kg intravenously, weekly, for 8 weeks. Patients with at least stable disease could continue treatment for an additional 4 weeks. Those with a partial or complete response after 12 weeks could receive extended MOR208 treatment (12 mg/kg, either monthly or every second week) until progression. The primary end point was overall response rate.Ninety-two patients were enrolled: DLBCL (n = 35), FL (n = 34), other iNHL (n = 11) and MCL (n = 12). Responses were observed in DLBCL, FL and other iNHL cohorts (26%, 29% and 27%, respectively). They lasted ≥12 months in 5/9 responding patients with DLBCL, 4/9 with FL and 2/3 with other iNHL. Responses in nine patients are ongoing (>26 months in five instances). Patients with rituximab refractory disease showed a similar response rate and progression-free survival time to patients with non-refractory disease. The most common adverse events (any grade) were infusion-related reactions (12%) and neutropenia (12%). One patient experienced a grade 4 infusion-related reaction and eight patients (9%) experienced grade 3/4 neutropenia. No treatment-related deaths were reported.MOR208 monotherapy demonstrated promising clinical activity in patients with R-R DLBCL and R-R FL, including in patients with rituximab refractory tumors. These efficacy data and the favorable safety profile support further investigation of MOR208 in phase II/III combination therapy trials in R-R DLBCL.NCT01685008.|
|Molecular Profile||Treatment Approach|
|Gene Name||Source||Synonyms||Protein Domains||Gene Description||Gene Role|
|Therapy Name||Drugs||Efficacy Evidence||Clinical Trials|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Gene||Variant||Impact||Protein Effect||Variant Description||Associated with drug Resistance|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||follicular lymphoma||not applicable||Tafasitamab-cxix||Phase II||Actionable||In a Phase II trial, follicular lymphoma patients tolerated Monjuvi (tafasitamab-cxix) treatment, and achieved an overall response rate of 29% (10/34, 3 complete and 7 partial response) with 4 patients responding over 12 months, a disease control rate of 76% (26/34), progression-free survival of 8.8 months at a median follow-up of 21 months, and a median duration of response was not reached (PMID: 29444231; NCT01685008).||29444231|
|Unknown unknown||mantle cell lymphoma||no benefit||Tafasitamab-cxix||Phase II||Actionable||In a Phase II trial, Monjuvi (tafasitamab-cxix) treatment was well-tolerated and resulted in stable disease as the best response in 50% (6/12) of patients with mantle cell lymphoma (PMID: 29444231; NCT01685008).||29444231|
|Unknown unknown||diffuse large B-cell lymphoma||not applicable||Tafasitamab-cxix||Phase II||Actionable||In a Phase II trial, diffuse large B-cell lymphoma patients tolerated Monjuvi (tafasitamab-cxix) treatment, and achieved an overall response rate of 26% (9/35, 2 complete and 7 partial response) with 5 patients responding over 12 months, a disease control rate of 40% (14/35), a median duration of response of 20.1 months and a progression-free survival of 2.7 months at a median follow-up of 21 months (PMID: 29444231; NCT01685008).||29444231|
|Unknown unknown||marginal zone B-cell lymphoma||not applicable||Tafasitamab-cxix||Phase II||Actionable||In a Phase II trial, Monjuvi (tafasitamab-cxix) treatment was well-tolerated, and resulted in 2 complete and 1 partial responses (n=9) in marginal zone lymphoma patients (PMID: 29444231; NCT01685008).||29444231|