RE-MIND STUDY: COMPARISON OF TAFASITAMAB + LENALIDOMIDE (L-MIND) VS LENALIDOMIDE MONOTHERAPY (REAL-WORLD DATA) IN TRANSPLANT-INELIGIBLE PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA
Author(s): ,
Pier Luigi Zinzani
Affiliations:
Institute of Hematology L e A Seràgnoli, University of Bologna,Bologna,Italy
,
Thomas Rodgers
Affiliations:
University of Rochester Medical Center,Rochester, NY,United States
,
Dario Marino
Affiliations:
Medical Oncology 1, Department of Oncology, Veneto Institute of Oncology IOV-IRCCS,Padua,Italy
,
Maurizio Frezzato
Affiliations:
Azienda ULSS 8 Berica,Vicenza,Italy
,
Anna Maria Barbui
Affiliations:
ASST Papa Giovanni XXIII,Bergamo,Italy
,
Claudia Castellino
Affiliations:
Hematology Division, Santa Croce and Carle Hospital,Cuneo,Italy
,
Erika Meli
Affiliations:
ASST Grande Ospedale Metropolitano Niguarda, Dipartimento di Ematologia e Oncologia, S.C. Ematologia,Milan,Italy
,
Annarita Conconi
Affiliations:
SSD Ematologia, Ospedale degli Infermi di Biella,Ponderano,Italy
,
Nicola Cascavilla
Affiliations:
Istituto di Ematologia, IRCCS Casa Sollievo della Sofferenza,San Giovanni Rotondo,Italy
,
Federica Cavallo
Affiliations:
Divisione Ematologia dell'Università di Torino, A.O.U. Citta della Salute e della Scienza di Torino,Turin,Italy
,
Nathan H. Fowler
Affiliations:
Department of Lymphoma/Myeloma,The University of Texas MD Anderson Cancer Center,Houston, TX,United States
,
Bruce Feinberg
Affiliations:
Cardinal Health Inc.,Dublin, OH,United States
,
Sascha Tillmanns
Affiliations:
MorphoSys AG,Planegg,Germany
,
Stephan Parche
Affiliations:
MorphoSys AG,Planegg,Germany
,
Günter Fingerle-Rowson
Affiliations:
MorphoSys AG,Planegg,Germany
,
Mark Winderlich
Affiliations:
MorphoSys AG,Planegg,Germany
,
Sumeet Ambarkhane
Affiliations:
MorphoSys AG,Planegg,Germany
,
Gilles Salles
Affiliations:
Hématologie, Hospices Civils de Lyon and Université de Lyon,Lyon,France
Grzegorz Nowakowski
Affiliations:
Division of Hematology, Mayo Clinic,Rochester, MN,United States
(Abstract release date: 05/14/20) EHA Library. Luigi Zinzani P. 06/12/20; 295058; S238
Prof. Dr. Pier Luigi Zinzani
Prof. Dr. Pier Luigi Zinzani
Contributions
Abstract

Abstract: S238

Type: Oral Presentation

Session title: Aggressive lymphomas: Observational studies

Background
Patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) ineligible for autologous stem cell transplant (ASCT) have a poor prognosis. Tafasitamab (MOR208) is an investigational, anti-CD19 humanized monoclonal antibody. Lenalidomide (LEN), an immunomodulatory drug, is active in patients with R/R DLBCL with modest activity. The combination of tafasitamab + LEN has shown encouraging results in the open-label, single-arm, Phase II L-MIND study (n=81, NCT02399085) in patients with R/R DLBCL ineligible for ASCT.

Aims
To estimate the tafasitamab contribution to the tafasitamab + LEN combination, we conducted a global study using real-world data (RWD) of patients treated with LEN monotherapy (RE-MIND, NCT04150328), applying estimated propensity score (ePS)-based matching methodology with the L-MIND cohort. Here, we present primary analysis results of a comparison between the two cohorts.

Methods
Patients treated with LEN monotherapy for R/R DLBCL were enrolled in the observational RE-MIND cohort. As in the L-MIND study, adult patients had 1–3 prior systemic therapies, including ≥1 CD20-targeting regimen, and were not eligible for ASCT. Baseline disease characteristics, LEN dosing information, and patient outcome data were collected retrospectively from health records.

A Nearest Neighbor 1:1 Matching Methodology, based on ePS, ensured that the two cohorts were adequately balanced for nine prespecified baseline covariates (age, stage, number of prior therapies, refractoriness to last prior therapy, primary refractoriness, prior ASCT, neutropenia, anemia, and elevated lactate dehydrogenase), with each L-MIND patient matched with a single observational cohort patient with similar baseline characteristics. The primary analysis set is the Matched Analysis Set 25 (MAS25), which includes ePS 1:1 matched patients who received a LEN starting dose of 25 mg/day (as in the L-MIND study).

The primary endpoint was investigator-assessed best objective response rate (ORR). Key secondary endpoints included overall survival (OS) and complete response (CR) rate.

Results
490 patients were enrolled in RE-MIND across 58 centers in the US and Europe, of which 140 fulfilled the inclusion criteria, had data on all baseline covariates, received a starting LEN dose of 25 mg/day, and qualified for the ePS-based 1:1 matching with the L-MIND cohort. The MAS25 included 76 patients each from the L-MIND and the observational cohorts. Baseline characteristics of the two cohorts, including the nine covariates used for 1:1 matching, were comparable.

The primary endpoint was met. A significantly better ORR of 67.1% (95% confidence interval [CI] 55.4–77.5) was reported for patients in the L-MIND cohort vs 34.2% (95% CI 23.7–46.0) for the observational cohort (odds ratio 3.89 [95% CI 1.90–8.14]; p<0.0001). Furthermore, a significant difference was observed in OS that favored the L-MIND cohort (hazard ratio 0.47 [95% CI 0.30–0.73]; Figure 1). CR rates were 39.5% (95% CI 28.4–51.4) in the L-MIND cohort vs 11.8% (95% CI 5.6–21.3) in the observational cohort.

Conclusion
Significantly better ORR, CR, and OS indicate potential synergistic effects of the tafasitamab + LEN combination in ASCT-ineligible R/R DLBCL. ePS-based 1:1 matching allows robust estimation of the treatment effect of tafasitamab when added to LEN. RE-MIND demonstrates the utility of RWD in interpreting non-randomized trials.

Session topic: 19. Aggressive Non-Hodgkin lymphoma - Clinical

Keyword(s): B cell lymphoma, CD19, DLBCL, Immune therapy

Abstract: S238

Type: Oral Presentation

Session title: Aggressive lymphomas: Observational studies

Background
Patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) ineligible for autologous stem cell transplant (ASCT) have a poor prognosis. Tafasitamab (MOR208) is an investigational, anti-CD19 humanized monoclonal antibody. Lenalidomide (LEN), an immunomodulatory drug, is active in patients with R/R DLBCL with modest activity. The combination of tafasitamab + LEN has shown encouraging results in the open-label, single-arm, Phase II L-MIND study (n=81, NCT02399085) in patients with R/R DLBCL ineligible for ASCT.

Aims
To estimate the tafasitamab contribution to the tafasitamab + LEN combination, we conducted a global study using real-world data (RWD) of patients treated with LEN monotherapy (RE-MIND, NCT04150328), applying estimated propensity score (ePS)-based matching methodology with the L-MIND cohort. Here, we present primary analysis results of a comparison between the two cohorts.

Methods
Patients treated with LEN monotherapy for R/R DLBCL were enrolled in the observational RE-MIND cohort. As in the L-MIND study, adult patients had 1–3 prior systemic therapies, including ≥1 CD20-targeting regimen, and were not eligible for ASCT. Baseline disease characteristics, LEN dosing information, and patient outcome data were collected retrospectively from health records.

A Nearest Neighbor 1:1 Matching Methodology, based on ePS, ensured that the two cohorts were adequately balanced for nine prespecified baseline covariates (age, stage, number of prior therapies, refractoriness to last prior therapy, primary refractoriness, prior ASCT, neutropenia, anemia, and elevated lactate dehydrogenase), with each L-MIND patient matched with a single observational cohort patient with similar baseline characteristics. The primary analysis set is the Matched Analysis Set 25 (MAS25), which includes ePS 1:1 matched patients who received a LEN starting dose of 25 mg/day (as in the L-MIND study).

The primary endpoint was investigator-assessed best objective response rate (ORR). Key secondary endpoints included overall survival (OS) and complete response (CR) rate.

Results
490 patients were enrolled in RE-MIND across 58 centers in the US and Europe, of which 140 fulfilled the inclusion criteria, had data on all baseline covariates, received a starting LEN dose of 25 mg/day, and qualified for the ePS-based 1:1 matching with the L-MIND cohort. The MAS25 included 76 patients each from the L-MIND and the observational cohorts. Baseline characteristics of the two cohorts, including the nine covariates used for 1:1 matching, were comparable.

The primary endpoint was met. A significantly better ORR of 67.1% (95% confidence interval [CI] 55.4–77.5) was reported for patients in the L-MIND cohort vs 34.2% (95% CI 23.7–46.0) for the observational cohort (odds ratio 3.89 [95% CI 1.90–8.14]; p<0.0001). Furthermore, a significant difference was observed in OS that favored the L-MIND cohort (hazard ratio 0.47 [95% CI 0.30–0.73]; Figure 1). CR rates were 39.5% (95% CI 28.4–51.4) in the L-MIND cohort vs 11.8% (95% CI 5.6–21.3) in the observational cohort.

Conclusion
Significantly better ORR, CR, and OS indicate potential synergistic effects of the tafasitamab + LEN combination in ASCT-ineligible R/R DLBCL. ePS-based 1:1 matching allows robust estimation of the treatment effect of tafasitamab when added to LEN. RE-MIND demonstrates the utility of RWD in interpreting non-randomized trials.

Session topic: 19. Aggressive Non-Hodgkin lymphoma - Clinical

Keyword(s): B cell lymphoma, CD19, DLBCL, Immune therapy

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